Impact Of The Nurse Enhanced Recovery After Surgery Coordinator On The Compliance In Colorectal Surgery (nursERAS-BCN)
NCT ID: NCT05231473
Last Updated: 2025-09-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
206 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-05-01
Study Completion Date
2025-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Purpose. The aim of this study is to evaluate the impact of the implementation of the Nurse Enhanced Recovery After Surgery Coordinator (NEC), within the Enhanced Recovery After Surgery (ERAS) program, in relation to the compliance of patients undergoing colorectal surgery.
Methods. Quasi-experimental study with a control group, an intervention group and without random assignment in a multicenter trial; between December 2021 and November 2023. Patients older than 18 years with planned elective intervention of major colorectal surgery will be included; excluding those without social support, with psychiatric illness, cognitive difficulty, planning of simultaneous or emergency surgery. In the intervention arm they will have NEC and in the control group they will not have that resource. Compliance will be the main variable of the study and, in addition, the study aims to assess secondary endpoints such as quality of life (QOL).
Conclusions. NEC could increase compliance to ERAS programs, improving health outcomes and QOL perceived by the patient. The applicability in the different hospital centers could generate an opportunity to advance professionally in the nursing figure within the ERAS program. The fact of having NEC could also increase the efficiency of the program due to the cost-effectiveness of the nursing position, although this is not the object of the study. It would be applicable in improving perceived health and QOL, so it could also have an economic impact on the health system.
Methods. Quasi-experimental study with a control group, an intervention group and without random assignment in a multicenter trial; between December 2021 and November 2023. Patients older than 18 years with planned elective intervention of major colorectal surgery will be included; excluding those without social support, with psychiatric illness, cognitive difficulty, planning of simultaneous or emergency surgery. In the intervention arm they will have NEC and in the control group they will not have that resource. Compliance will be the main variable of the study and, in addition, the study aims to assess secondary endpoints such as quality of life (QOL).
Conclusions. NEC could increase compliance to ERAS programs, improving health outcomes and QOL perceived by the patient. The applicability in the different hospital centers could generate an opportunity to advance professionally in the nursing figure within the ERAS program. The fact of having NEC could also increase the efficiency of the program due to the cost-effectiveness of the nursing position, although this is not the object of the study. It would be applicable in improving perceived health and QOL, so it could also have an economic impact on the health system.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol
NCT03012802
Perioperative Care
Postoperative Complications
Colorectal Surgery
+1 more
COMPLETED
Effects of Implementing an ERAS Protocol
NCT06010225
Enhanced Recovery After Surgery (ERAS) Protocol
Colorectal Surgery
Effectivity
+2 more
COMPLETED
Long-term Enlarged Survival After an Enhanced Recovery Protocol (LESAS).
NCT04305314
Major Surgery
UNKNOWN
ERAS in Colorectal Surgery: Benefits of Late Adoption
NCT05773248
Colorectal Cancer
Colorectal Neoplasms
Colorectal Disorders
COMPLETED
POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol
NCT06369194
Colorectal Surgery
Critical Pathways
Enhanced Recovery After Surgery
+2 more
ACTIVE_NOT_RECRUITING
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background. Fast-track Surgery or Enhanced Recovery After Surgery (ERAS), also called multimodal rehabilitation in Spain, constitutes the application of a series of perioperative measures and strategies aimed at those patients who undergo surgery with the objective to reduce surgical stress, promoting a better recovery of the patient by significantly reducing complications and mortality.
The ERAS programs have represented an important change in the surgical field since it opens a new line of action different from the traditional one. These protocols include a set of perioperative measures applied in a multidisciplinary way, whose advantages have been scientifically endorsed. However, these programs still face more traditional attitudes and practices, so their application is still limited today.
The Nurse ERAS Coordinator (NEC) was integrated into the multidisciplinary teams at the same time of implementation of the programs in the northern European countries, betting on their leadership and capacity from the beginning. This figure ensures that the ERAS guidelines advance in the process until their final approval and participate in the fulfillment of the protocol in the different phases. They carry out interventions based on as much evidence as possible and contribute to the collection of data for ongoing audits. In addition, they are characterized by high levels of communication skills, resourcefulness and innovation, these being key attributes of the ERAS coordinator and favoring the participation of the entire multidisciplinary team through organizational change.
Starting in the 1990s, two groups of surgeons presented different measures to improve the postoperative evolution of patients who underwent elective colorectal surgery. Both groups emphasized the importance of the information provided to the patient and its role in postoperative recovery. In Europe, specifically at the Hvidovre University Hospital in Denmark, the first group led by Kehlet emerged, who proposed different strategies to improve the postoperative period of these patients; also acting preoperatively and during surgery. Years later, the second group emerged in the United States, led by Delaney et al. from the Cleveland Clinic, who focused his studies on postoperative improvement based on the advances of the previous group, specifically in the administration of an early diet and the stimulation of early mobilization. In this way, the ERAS programs emerged.
However, it was not until 2001, when the ERAS group was formed, made up of different colorectal surgery units from 5 northern European countries (Scotland, Sweden, Denmark, Norway and the Netherlands). This group agreed on what they would call the ERAS project led by Kehlet. The recommended actions began at the moment of diagnosis and sought to recognize the individual needs of the patient to optimize their treatment before, during and after surgery.
Most of the studies whose objective has been to evaluate the efficacy of the measures that make up the ERAS program, agree that their implementation is beneficial for patients and is directly related to compliance with these measures in each of the perioperative phases.
In this sense, it is essential to consider the following key points of the program, extracted from the consensus of experts and published guides:
1. All patients participating in the protocol must start it preoperatively, which allows them a faster recovery from surgery and postoperative convalescence, minimizing physical and psychological stress.
2. The prior preparation of the patient is essential and ensures that he is in the best possible condition, identifying personal risks in the preoperative.
3. The treatment is comprehensive and includes pre, intra and postoperative measures in which the investigators act actively.
4. Patients have an active role and must take responsibility to improve their recovery.
5. Preoperative or prehabilitation period: to optimize the physical, nutritional, emotional, medical and pharmacological status of the patient; to arrive at surgery in the best possible conditions.
6. Intraoperative period: laparoscopic surgery, fluid restriction, pain control, multimodal analgesia.
7. Postoperative period: ambulation and early intake, antithrombotic measures, respiratory physiotherapy.
The implementation of ERAS programs also contributes to the improvement in the QOL perceived by the patient during the first phases of recovery. Furthermore, as a consequence, it produces a reduced general economic cost due to the decrease in the average stay in most cases.
Despite all the above, there is no evidence available that evaluates the direct impact of the NEC figure, which was implemented in 2001 in Northern Europe, the United States and Canada with a fundamental role. This is the first trial that analyzes the impact on compliance and, therefore, on health and QOL results in patients with colorectal surgery within ERAS programs.
Ethics. The study will be carried out in accordance with the Declaration of Helsinki and the Spanish laws and regulations for biomedical research. The trial protocol and patient information have been approved by the competent Ethics Committees of all participating trial centers. The data collection is part of the usual clinical practice of each participating center. For the present study, the data will be collected from the electronic medical record; therefore, the Research Ethics Committee is requested to exempt the informed consent.
During the trial, the database will not contain any identifying information about the patient. A separate document will contain the relationship of each patient with the assignment of an alphanumeric code, to which only the main researcher of the project will have access. Trials findings will be stored in accordance with Spanish data protection law (Law 15/1999 on the protection of personal data) and will be handled in strictest confidence. For protection of these data, organizational procedures are implemented to prevent distribution of data to unauthorized people.
Management of patients and Follow-up. The program was presented to the Ethics and Research Committees Clinic of both centers to, after approval, be coordinated by the NEC in BUH. NEC will be in charge of informing and training all professionals involved in any service and discipline. She will be responsible for appointing a referral from each specialty, with whom she will communicate constantly and through which all the information will be distributed through the different professionals.
Before starting the program, meetings will be convened with the heads of anesthesiology service, general and digestive surgery and nursing. The purpose of these meetings initially will be to establish synergies and align shared objectives.
Data will be collected by different professionals at each stage, but it will be the NEC who ensures and supervises the correct completion of them throughout the process. In the preadmission stage will be registered by the NEC, as well as in the immediate preoperative stage. To intraoperative level, the responsible anesthesiologist will register it. Finally, the team of surgeons will record the variables in the postoperative period. The measurement of the compliance variable will be based on the indicators of colorectal process: 17 process indicators and 2 result indicators will be evaluated following the ERAS Society audit guidelines.
Regarding the measurement of QOL, a self-administered questionnaire on the first visit of the program by the NEC, re-administering the same at 90 days postoperative: SF-12 to all patients, EORTC QLQ C30 and CR-29 in case of neoplasia.
In HGTiP, the hospital which does not have NEC, it will be the lead surgeon or head of the program who assumes this role in all the stages.
Sample size of the study. The sample size for two independent proportions (compliance), accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 103 subjects are necessary in first group and 103 in the second to find as statistically significant a proportion difference, expected to be of 0.5 in intervention group and 0.3 in control group. It has been anticipated a drop-out rate of 10%.
Statistical analysis. Descriptive methods will be used to present the distribution of variables in the study groups, with frequencies and percentages with the corresponding 95% confidence interval (CI) for categorical variables, and mean and standard deviation (SD) or median and interquartile range (25th-75th percentile) for quantitative variables. The chi-square (χ2) test will be used for the comparison of categorical variables. Clinically relevant or statistically significant variables in the bivariate analysis as well as possible confounding variables will be analyzed in a binary logistic regression model. The Mann-Whitney test will be used for the comparison of continuous variables. Also, a longitudinal analysis of variables collected at follow-up (QOL) will be performed. Statistical significance is set at P\< 0.05. All analyses will be done using SPSS program, version 26.0.
Discussion. ERAS programs incorporate a series of evidence-based strategies with the aim of reducing the stress triggered by surgery and increasing functional recovery. This implies a reduction in postoperative complications, hospital stay and generates health savings. Monitoring the degree of compliance with the different strategies is necessary, not only to assess its quality and identify points for improvement, but also because the level of compliance with the program influences the patients' health results.
Despite heterogeneity in coordination and management, ERAS programs are evaluated as successful from a nurse's perspective. Continuous staff education and coordination beyond the implementation period appear to be of the utmost importance for a sustained program and the role of NEC is very important.
The available evidence suggests patients suffer no detriment to satisfaction or QOL with use of ERAS protocols, and may suffer less fatigue and return to activities sooner. The use of ERAS protocols in colorectal surgery achieves a positive influence, not only by decreasing surgical-related complications but also in terms of functional recovery, by decreasing the negative effects of surgery on patient QOL.
The main objective of this study is to demonstrate that the tertiary hospitals that integrate the NEC in the ERAS programs, obtain a higher compliance than the hospitals that do not; improving health outcomes and perceived QOL of elective colorectal surgery patients.
The investigators believe that the NEC can be a key element in the implementation of ERAS programs, commonly coordinated by surgeons and anaesthesiologists, since as described above, they are part of the implementation team and would only require a role of competencies enlarged; having more prominence in the status of projects.
In addition, the investigators consider that having this figure could lead to an improvement in the QOL perceived by the patient within the ERAS programs, due to the monitoring carried out by the ERAS Nurse Coordinator throughout the perioperative process according to the definition of its functions and the possible increase in compliance with the protocol it causes, improving health outcomes.
At the same time, lower secondary morbidity can translate into lower hospital costs (fewer stays and fewer admissions).
The ERAS programs have represented an important change in the surgical field since it opens a new line of action different from the traditional one. These protocols include a set of perioperative measures applied in a multidisciplinary way, whose advantages have been scientifically endorsed. However, these programs still face more traditional attitudes and practices, so their application is still limited today.
The Nurse ERAS Coordinator (NEC) was integrated into the multidisciplinary teams at the same time of implementation of the programs in the northern European countries, betting on their leadership and capacity from the beginning. This figure ensures that the ERAS guidelines advance in the process until their final approval and participate in the fulfillment of the protocol in the different phases. They carry out interventions based on as much evidence as possible and contribute to the collection of data for ongoing audits. In addition, they are characterized by high levels of communication skills, resourcefulness and innovation, these being key attributes of the ERAS coordinator and favoring the participation of the entire multidisciplinary team through organizational change.
Starting in the 1990s, two groups of surgeons presented different measures to improve the postoperative evolution of patients who underwent elective colorectal surgery. Both groups emphasized the importance of the information provided to the patient and its role in postoperative recovery. In Europe, specifically at the Hvidovre University Hospital in Denmark, the first group led by Kehlet emerged, who proposed different strategies to improve the postoperative period of these patients; also acting preoperatively and during surgery. Years later, the second group emerged in the United States, led by Delaney et al. from the Cleveland Clinic, who focused his studies on postoperative improvement based on the advances of the previous group, specifically in the administration of an early diet and the stimulation of early mobilization. In this way, the ERAS programs emerged.
However, it was not until 2001, when the ERAS group was formed, made up of different colorectal surgery units from 5 northern European countries (Scotland, Sweden, Denmark, Norway and the Netherlands). This group agreed on what they would call the ERAS project led by Kehlet. The recommended actions began at the moment of diagnosis and sought to recognize the individual needs of the patient to optimize their treatment before, during and after surgery.
Most of the studies whose objective has been to evaluate the efficacy of the measures that make up the ERAS program, agree that their implementation is beneficial for patients and is directly related to compliance with these measures in each of the perioperative phases.
In this sense, it is essential to consider the following key points of the program, extracted from the consensus of experts and published guides:
1. All patients participating in the protocol must start it preoperatively, which allows them a faster recovery from surgery and postoperative convalescence, minimizing physical and psychological stress.
2. The prior preparation of the patient is essential and ensures that he is in the best possible condition, identifying personal risks in the preoperative.
3. The treatment is comprehensive and includes pre, intra and postoperative measures in which the investigators act actively.
4. Patients have an active role and must take responsibility to improve their recovery.
5. Preoperative or prehabilitation period: to optimize the physical, nutritional, emotional, medical and pharmacological status of the patient; to arrive at surgery in the best possible conditions.
6. Intraoperative period: laparoscopic surgery, fluid restriction, pain control, multimodal analgesia.
7. Postoperative period: ambulation and early intake, antithrombotic measures, respiratory physiotherapy.
The implementation of ERAS programs also contributes to the improvement in the QOL perceived by the patient during the first phases of recovery. Furthermore, as a consequence, it produces a reduced general economic cost due to the decrease in the average stay in most cases.
Despite all the above, there is no evidence available that evaluates the direct impact of the NEC figure, which was implemented in 2001 in Northern Europe, the United States and Canada with a fundamental role. This is the first trial that analyzes the impact on compliance and, therefore, on health and QOL results in patients with colorectal surgery within ERAS programs.
Ethics. The study will be carried out in accordance with the Declaration of Helsinki and the Spanish laws and regulations for biomedical research. The trial protocol and patient information have been approved by the competent Ethics Committees of all participating trial centers. The data collection is part of the usual clinical practice of each participating center. For the present study, the data will be collected from the electronic medical record; therefore, the Research Ethics Committee is requested to exempt the informed consent.
During the trial, the database will not contain any identifying information about the patient. A separate document will contain the relationship of each patient with the assignment of an alphanumeric code, to which only the main researcher of the project will have access. Trials findings will be stored in accordance with Spanish data protection law (Law 15/1999 on the protection of personal data) and will be handled in strictest confidence. For protection of these data, organizational procedures are implemented to prevent distribution of data to unauthorized people.
Management of patients and Follow-up. The program was presented to the Ethics and Research Committees Clinic of both centers to, after approval, be coordinated by the NEC in BUH. NEC will be in charge of informing and training all professionals involved in any service and discipline. She will be responsible for appointing a referral from each specialty, with whom she will communicate constantly and through which all the information will be distributed through the different professionals.
Before starting the program, meetings will be convened with the heads of anesthesiology service, general and digestive surgery and nursing. The purpose of these meetings initially will be to establish synergies and align shared objectives.
Data will be collected by different professionals at each stage, but it will be the NEC who ensures and supervises the correct completion of them throughout the process. In the preadmission stage will be registered by the NEC, as well as in the immediate preoperative stage. To intraoperative level, the responsible anesthesiologist will register it. Finally, the team of surgeons will record the variables in the postoperative period. The measurement of the compliance variable will be based on the indicators of colorectal process: 17 process indicators and 2 result indicators will be evaluated following the ERAS Society audit guidelines.
Regarding the measurement of QOL, a self-administered questionnaire on the first visit of the program by the NEC, re-administering the same at 90 days postoperative: SF-12 to all patients, EORTC QLQ C30 and CR-29 in case of neoplasia.
In HGTiP, the hospital which does not have NEC, it will be the lead surgeon or head of the program who assumes this role in all the stages.
Sample size of the study. The sample size for two independent proportions (compliance), accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 103 subjects are necessary in first group and 103 in the second to find as statistically significant a proportion difference, expected to be of 0.5 in intervention group and 0.3 in control group. It has been anticipated a drop-out rate of 10%.
Statistical analysis. Descriptive methods will be used to present the distribution of variables in the study groups, with frequencies and percentages with the corresponding 95% confidence interval (CI) for categorical variables, and mean and standard deviation (SD) or median and interquartile range (25th-75th percentile) for quantitative variables. The chi-square (χ2) test will be used for the comparison of categorical variables. Clinically relevant or statistically significant variables in the bivariate analysis as well as possible confounding variables will be analyzed in a binary logistic regression model. The Mann-Whitney test will be used for the comparison of continuous variables. Also, a longitudinal analysis of variables collected at follow-up (QOL) will be performed. Statistical significance is set at P\< 0.05. All analyses will be done using SPSS program, version 26.0.
Discussion. ERAS programs incorporate a series of evidence-based strategies with the aim of reducing the stress triggered by surgery and increasing functional recovery. This implies a reduction in postoperative complications, hospital stay and generates health savings. Monitoring the degree of compliance with the different strategies is necessary, not only to assess its quality and identify points for improvement, but also because the level of compliance with the program influences the patients' health results.
Despite heterogeneity in coordination and management, ERAS programs are evaluated as successful from a nurse's perspective. Continuous staff education and coordination beyond the implementation period appear to be of the utmost importance for a sustained program and the role of NEC is very important.
The available evidence suggests patients suffer no detriment to satisfaction or QOL with use of ERAS protocols, and may suffer less fatigue and return to activities sooner. The use of ERAS protocols in colorectal surgery achieves a positive influence, not only by decreasing surgical-related complications but also in terms of functional recovery, by decreasing the negative effects of surgery on patient QOL.
The main objective of this study is to demonstrate that the tertiary hospitals that integrate the NEC in the ERAS programs, obtain a higher compliance than the hospitals that do not; improving health outcomes and perceived QOL of elective colorectal surgery patients.
The investigators believe that the NEC can be a key element in the implementation of ERAS programs, commonly coordinated by surgeons and anaesthesiologists, since as described above, they are part of the implementation team and would only require a role of competencies enlarged; having more prominence in the status of projects.
In addition, the investigators consider that having this figure could lead to an improvement in the QOL perceived by the patient within the ERAS programs, due to the monitoring carried out by the ERAS Nurse Coordinator throughout the perioperative process according to the definition of its functions and the possible increase in compliance with the protocol it causes, improving health outcomes.
At the same time, lower secondary morbidity can translate into lower hospital costs (fewer stays and fewer admissions).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
ERAS
Enhanced Recovery
Compliance, Treatment
Compliance, Patient
Nurse's Role
Colon Disease
Rectum Disease
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
This study is designed as a quasi-experimental study with a control group, an intervention group, without random assignment and multicenter trial; which is carried out at two centers in Barcelona, Spain: Bellvitge University Hospital (BUH) and Hospital Germans Trias i Pujol (HGTiP), between December 2021 and November 2023. The participants are assigned according to the implanted and functioning program of each center, to one of two arms: a control arm, in which they join the ERAS program without NEC (group I), and an intervention arm, in which the participants will be included in the ERAS program with NEC (group II).
In HGTiP, the ERAS program without NEC is carried out in a standardized way, and in BUH it is carried out with NEC for all patients. The study directly compares both programs and their compliance in patients who are candidates for elective colorectal surgery.
In HGTiP, the ERAS program without NEC is carried out in a standardized way, and in BUH it is carried out with NEC for all patients. The study directly compares both programs and their compliance in patients who are candidates for elective colorectal surgery.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard
The participants are assigned according to the implanted and functioning program of each center. In this case, without Nurse Enhanced Recovery After Surgery Coordinator. It will be the control group. ERAS program will be working without this role.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Nurse Coordinator
The participants are assigned according to the implanted and functioning program of each center. In this case, with Nurse Enhanced Recovery After Surgery Coordinator. It will be the intervention group. ERAS program will be working with this role.
Group Type
EXPERIMENTAL
Nurse Enhanced Recovery After Surgery participation
Intervention Type
OTHER
Bellvitge University Hospital will include the NEC participation along Enhanced Recovery After Surgery program.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nurse Enhanced Recovery After Surgery participation
Bellvitge University Hospital will include the NEC participation along Enhanced Recovery After Surgery program.
Intervention Type
OTHER
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
NEC participation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients over 18 years of age
* Candidates to elective major colorectal surgery due to benign or malignant pathology
* Candidates to elective major colorectal surgery due to benign or malignant pathology
Exclusion Criteria
* Rejection of the patient to participate in ERAS program
* Inadequate social support that makes it difficult to comply with a discharge planned hospital
* Associated psychiatric illness, mental or organic disorders which could interfere with receiving treatments or indications about the program
* Patients with combined surgeries or simultaneous with other specialties by synchronism.
* Patients with emergency surgery
* Inadequate social support that makes it difficult to comply with a discharge planned hospital
* Associated psychiatric illness, mental or organic disorders which could interfere with receiving treatments or indications about the program
* Patients with combined surgeries or simultaneous with other specialties by synchronism.
* Patients with emergency surgery
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Germans Trias i Pujol Hospital
OTHER
Sponsor Role
collaborator
University of Barcelona
OTHER
Sponsor Role
collaborator
Hospital Universitari de Bellvitge
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
José Antonio Jerez González
Enhanced Recovery After Surgery Coordinator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jose Antonio Jerez-Gonzalez, MSc
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge
M.Carmen Moreno-Arroyo, PhD
Role: STUDY_DIRECTOR
University of Barcelona
Miguel Angel Hidalgo-Blanco, PhD
Role: STUDY_DIRECTOR
University of Barcelona
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bellvitge University Hospital
L'Hospitalet de Llobregat, Barcelona, Spain
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Spain
References
Explore related publications, articles, or registry entries linked to this study.
Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.
Reference Type
BACKGROUND
Kehlet H, Wilmore DW. Fast-track surgery. Br J Surg. 2005 Jan;92(1):3-4. doi: 10.1002/bjs.4841. No abstract available.
Reference Type
BACKGROUND
Gustafsson UO, Oppelstrup H, Thorell A, Nygren J, Ljungqvist O. Adherence to the ERAS protocol is Associated with 5-Year Survival After Colorectal Cancer Surgery: A Retrospective Cohort Study. World J Surg. 2016 Jul;40(7):1741-7. doi: 10.1007/s00268-016-3460-y.
Reference Type
BACKGROUND
Baimas-George M, Cochran A, Tezber K, Kirks RC, Addor V, Baker E, Martinie J, Iannitti D, Vrochides D. A 2-Year Experience With Enhanced Recovery After Surgery: Evaluation of Compliance and Outcomes in Pancreatic Surgery. J Nurs Care Qual. 2021 Apr-Jun 01;36(2):E24-E28. doi: 10.1097/NCQ.0000000000000487.
Reference Type
BACKGROUND
Watson DJ. Nurse coordinators and ERAS programs. Nurs Manage. 2018 Jan;49(1):42-49. doi: 10.1097/01.NUMA.0000527718.90264.89. No abstract available.
Reference Type
BACKGROUND
Gillissen F, Hoff C, Maessen JM, Winkens B, Teeuwen JH, von Meyenfeldt MF, Dejong CH. Structured synchronous implementation of an enhanced recovery program in elective colonic surgery in 33 hospitals in The Netherlands. World J Surg. 2013 May;37(5):1082-93. doi: 10.1007/s00268-013-1938-4.
Reference Type
BACKGROUND
Delaney CP, Fazio VW, Senagore AJ, Robinson B, Halverson AL, Remzi FH. 'Fast track' postoperative management protocol for patients with high co-morbidity undergoing complex abdominal and pelvic colorectal surgery. Br J Surg. 2001 Nov;88(11):1533-8. doi: 10.1046/j.0007-1323.2001.01905.x.
Reference Type
BACKGROUND
Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
Reference Type
BACKGROUND
Anderson AD, McNaught CE, MacFie J, Tring I, Barker P, Mitchell CJ. Randomized clinical trial of multimodal optimization and standard perioperative surgical care. Br J Surg. 2003 Dec;90(12):1497-504. doi: 10.1002/bjs.4371.
Reference Type
BACKGROUND
Delaney CP, Zutshi M, Senagore AJ, Remzi FH, Hammel J, Fazio VW. Prospective, randomized, controlled trial between a pathway of controlled rehabilitation with early ambulation and diet and traditional postoperative care after laparotomy and intestinal resection. Dis Colon Rectum. 2003 Jul;46(7):851-9. doi: 10.1007/s10350-004-6672-4.
Reference Type
BACKGROUND
Gatt M, Anderson AD, Reddy BS, Hayward-Sampson P, Tring IC, MacFie J. Randomized clinical trial of multimodal optimization of surgical care in patients undergoing major colonic resection. Br J Surg. 2005 Nov;92(11):1354-62. doi: 10.1002/bjs.5187.
Reference Type
BACKGROUND
Khoo CK, Vickery CJ, Forsyth N, Vinall NS, Eyre-Brook IA. A prospective randomized controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer. Ann Surg. 2007 Jun;245(6):867-72. doi: 10.1097/01.sla.0000259219.08209.36.
Reference Type
BACKGROUND
Muller S, Zalunardo MP, Hubner M, Clavien PA, Demartines N; Zurich Fast Track Study Group. A fast-track program reduces complications and length of hospital stay after open colonic surgery. Gastroenterology. 2009 Mar;136(3):842-7. doi: 10.1053/j.gastro.2008.10.030. Epub 2008 Nov 1.
Reference Type
BACKGROUND
Serclova Z, Dytrych P, Marvan J, Nova K, Hankeova Z, Ryska O, Slegrova Z, Buresova L, Travnikova L, Antos F. Fast-track in open intestinal surgery: prospective randomized study (Clinical Trials Gov Identifier no. NCT00123456). Clin Nutr. 2009 Dec;28(6):618-24. doi: 10.1016/j.clnu.2009.05.009. Epub 2009 Jun 17.
Reference Type
BACKGROUND
Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.
Reference Type
BACKGROUND
Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.
Reference Type
BACKGROUND
Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.
Reference Type
BACKGROUND
Shanahan JL, Leissner KB. Prehabilitation for the Enhanced Recovery After Surgery Patient. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):880-882. doi: 10.1089/lap.2017.0328. Epub 2017 Jul 28.
Reference Type
BACKGROUND
Brooks NA, Kokorovic A, McGrath JS, Kassouf W, Collins JW, Black PC, Douglas J, Djaladat H, Daneshmand S, Catto JWF, Kamat AM, Williams SB. Critical analysis of quality of life and cost-effectiveness of enhanced recovery after surgery (ERAS) for patient's undergoing urologic oncology surgery: a systematic review. World J Urol. 2022 Jun;40(6):1325-1342. doi: 10.1007/s00345-020-03341-6. Epub 2020 Jul 9.
Reference Type
BACKGROUND
Watson DJ. The role of the nurse coordinator in the enhanced recovery after surgery program. Nursing. 2017 Sep;47(9):13-17. doi: 10.1097/01.NURSE.0000522018.00182.c7. No abstract available.
Reference Type
BACKGROUND
Balfour A, Burch J, Fecher-Jones I, Carter FJ. Understanding the benefits and implications of Enhanced Recovery After Surgery. Nurs Stand. 2019 Jul 5;34(7):70-75. doi: 10.7748/ns.2019.e11306.
Reference Type
BACKGROUND
Elias KM, Stone AB, McGinigle K, Tankou JI, Scott MJ, Fawcett WJ, Demartines N, Lobo DN, Ljungqvist O, Urman RD; ERAS(R) Society and ERAS(R) USA. The Reporting on ERAS Compliance, Outcomes, and Elements Research (RECOvER) Checklist: A Joint Statement by the ERAS(R) and ERAS(R) USA Societies. World J Surg. 2019 Jan;43(1):1-8. doi: 10.1007/s00268-018-4753-0.
Reference Type
BACKGROUND
Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
Reference Type
BACKGROUND
Calderon C, Ferrando PJ, Lorenzo-Seva U, Ferreira E, Lee EM, Oporto-Alonso M, Obispo-Portero BM, Mihic-Gongora L, Rodriguez-Gonzalez A, Jimenez-Fonseca P. Psychometric properties of the Spanish version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Qual Life Res. 2022 Jun;31(6):1859-1869. doi: 10.1007/s11136-021-03068-w. Epub 2021 Dec 20.
Reference Type
BACKGROUND
Arraras JI, Suarez J, Arias de la Vega F, Vera R, Asin G, Arrazubi V, Rico M, Teijeira L, Azparren J. The EORTC Quality of Life questionnaire for patients with colorectal cancer: EORTC QLQ-CR29 validation study for Spanish patients. Clin Transl Oncol. 2011 Jan;13(1):50-6. doi: 10.1007/s12094-011-0616-y.
Reference Type
BACKGROUND
Schmidt S, Vilagut G, Garin O, Cunillera O, Tresserras R, Brugulat P, Mompart A, Medina A, Ferrer M, Alonso J. [Reference guidelines for the 12-Item Short-Form Health Survey version 2 based on the Catalan general population]. Med Clin (Barc). 2012 Dec 8;139(14):613-25. doi: 10.1016/j.medcli.2011.10.024. Epub 2012 Jan 11. Spanish.
Reference Type
BACKGROUND
Ban KA, Berian JR, Ko CY. Does Implementation of Enhanced Recovery after Surgery (ERAS) Protocols in Colorectal Surgery Improve Patient Outcomes? Clin Colon Rectal Surg. 2019 Mar;32(2):109-113. doi: 10.1055/s-0038-1676475. Epub 2019 Feb 28.
Reference Type
BACKGROUND
Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
Reference Type
BACKGROUND
ERAS Compliance Group. The Impact of Enhanced Recovery Protocol Compliance on Elective Colorectal Cancer Resection: Results From an International Registry. Ann Surg. 2015 Jun;261(6):1153-9. doi: 10.1097/SLA.0000000000001029.
Reference Type
BACKGROUND
Pache, B., Hübner, M., Martin, D. et al. Requirements for a successful Enhanced Recovery After Surgery (ERAS) program: a multicenter international survey among ERAS nurses. Eur Surg 53, 246-250 (2021). https://doi.org/10.1007/s10353-021-00698-9
Reference Type
BACKGROUND
Leon Arellano M, Tejedor P, Guadalajara H, Ortega M, Garcia Olmo D, Pastor C. Evolution of perioperative quality of life in patients under enhanced recovery after surgery care in colorectal cancer. Rev Esp Enferm Dig. 2020 Feb;112(2):127-132. doi: 10.17235/reed.2020.6423/2019.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PR426/21
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER)
NCT03814681
UNKNOWN
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
NCT04595604
COMPLETED
NA
Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment
NCT06342687
COMPLETED
Well-being and Stress Control After Colorectal Surgery
NCT03844347
TERMINATED
NA
Effect of Implementation of Enhanced Recovery After Surgery on 3-year Survival After Colorectal Surgery for Cancer
NCT05002855
COMPLETED
Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer
NCT03865810
UNKNOWN
First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery
NCT06008834
UNKNOWN
NA
Enhanced Recovery Program in Laparoscopic Colorectal Surgery: an Observational Controlled Trial
NCT04378465
COMPLETED
Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care
NCT03760939
TERMINATED
NA
Enhanced Recovery After Colorectal Surgery
NCT01148394
COMPLETED
NA
Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial
NCT03928678
COMPLETED
NA
Quality of Life After Enhanced Recovery Protocol for Colorectal Surgery
NCT02824783
COMPLETED
Impact of a Colorectal Enhanced Recovery Program Implementation on Clinical Outcomes and Institutional Costs
NCT03382210
COMPLETED
"Impact of Pelvic Floor Prehabilitation Using Biofeedback on the Severity of the Low Anterior Resection Syndrome in Patients Undergoing a Total Mesorectal Excision for Rectal Cancer"
NCT03876561
UNKNOWN
NA
Enhanced Recovery After Surgery in Major Intrabdominal Procedures.
NCT01400711
COMPLETED
NA
Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.
NCT04612569
UNKNOWN
Multimodal Prehabilitation in Colorectal Cancer Patients
NCT06443203
ACTIVE_NOT_RECRUITING
NA
ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery
NCT04037787
COMPLETED
NA
Enhanced Recovery After Surgery in Colorectal Surgery: A Large-Scale Quality Improvement Project
NCT03189550
COMPLETED
ERAS in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery
NCT02527967
COMPLETED
Pragmatic Prehabilitation for Colorectal Surgery
NCT04247776
COMPLETED
NA
Prehabilitation Versus Enhanced Recovery Program for Elective Colorectal Cancer Surgery.
NCT03758209
COMPLETED
NA
Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS
NCT04896879
COMPLETED
Enhanced Recovery After Laparoscopic Colorectal Surgery Study
NCT04091815
UNKNOWN
NA
POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol After Gastric Surgery (POWER 4 + 3)
NCT06790238
ACTIVE_NOT_RECRUITING