Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery
NCT ID: NCT03771456
Last Updated: 2018-12-11
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
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Recruitment Status
UNKNOWN
Total Enrollment
1748 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-01-07
Study Completion Date
2019-12-31
Brief Summary
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Prospective observational multicenter study on the influence of adherence to enhanced recovery pathways on early outcomes (anastomotic leakage, morbidity, mortality, readmission, reoperation rates and length of postoperative stay) after elective colorectal surgery in Italy.
Detailed Description
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BACKGROUND
Anastomotic leakage (AL) is a dreaded major complication after colorectal surgery. The overall incidence of anastomotic dehiscence and subsequent leaks is 2 to 7 percent when performed by experienced surgeons. The lowest leak rates are found with ileocolic anastomoses (1 to 3 percent) and the highest occur with coloanal anastomosis (10 to 20 percent). Leaks usually become apparent between five and seven days postoperatively. Almost half of all leaks occur after the patient has been discharged, and up to 12 percent occur after postoperative day (POD) 30. Late leaks often present insidiously with low-grade fever, prolonged ileus, and nonspecific symptoms attributable to other postoperative infectious complications. Small, contained leaks present later in the clinical course and may be difficult to distinguish from postoperative abscesses by radiologic imaging, making the diagnosis uncertain and underreported.
There is no uniform definition of an anastomotic dehiscence and leak. In a review of 97 studies, as an example, 56 different definitions of an anastomotic leak were used. The majority of reports define an anastomotic leak using clinical signs, radiographic findings, and intraoperative findings. The clinical signs include: Pain, Fever, Tachycardia, Peritonitis, Feculent drainage, Purulent drainage. The radiographic signs include: Fluid collections, Gas containing collections. The intraoperative findings include: Gross enteric spillage, Anastomotic disruption.
Risk factors for a dehiscence and leak are classified according to the site of the anastomosis (extraperitoneal or intraperitoneal). A prospective review of 1598 patients undergoing 1639 anastomotic procedures for benign or malignant colorectal disease found a significantly increased risk of anastomotic leak with extraperitoneal compared with intraperitoneal anastomoses (6.6 versus 1.5 percent; 2.4 percent overall).
Major risk factors for an extraperitoneal AL include: The distance of the anastomosis from the anal verge (Patients with a low anterior resection and an anastomosis within 5 cm from the anal verge are the highest risk group for an anastomotic leak), Anastomotic ischemia, Male gender, Obesity.
Major risk factors for an intraperitoneal AL include: American Society of Anesthesiologists (ASA) score Grade III to V, Emergent surgery, Prolonged operative time, Hand-sewn ileocolic anastomosis.
Controversial, inconclusive, or pertinent negative associations between the following variables and AL have been reported: Neoadjuvant radiation therapy, Drains, Protective stoma, Hand-sewn colorectal anastomosis, Laparoscopic procedure, Mechanical bowel preparation, Nutritional status, Perioperative corticosteroids.
Enhanced Recovery After Surgery (ERAS) programs for colorectal surgery have been extensively studied during the last 20 years. It is now clear that they offer a consistent reduction of overall morbidity rates, postoperative length of stay and costs, and that there is a clear dose-effect relation between adherence to at least 60-70% of the program items and these outcomes. On the other hand, little is known concerning the potential benefit of ERAS programs over AL rates or if adherence to specific items of the program may reduce AL rates.
Therefore, the investigators planned this study to prospectively evaluate AL rates after colorectal resections and their interaction with known risk factors and ERAS program items.
METHODS
Prospective enrollment from January to December 2019 in 41 Italian surgical centers. All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after having provided a written informed consent. A total of 1,750 patients is expected based on a mean of 43 cases/year per center.
Outcome measures
1. Preoperative risk factors of anastomotic leakage (age, gender, obesity, nutritional status, diabetes, cardiovascular disease, chronic liver disease, renal failure, inflammatory bowel disease, perioperative steroid therapy, ASA class I-II vs III)
2. Operative parameters (approach, procedure, anastomotic technique, length of operation, disease stage)
3. ERAS program items (prehabilitation, counseling, nutritional evaluation, immuno-nutrition, deep venous thrombosis prophylaxis, antibiotic prophylaxis, bowel preparation, preoperative carbohydrates load, standardized anesthesia protocol, restrictive i.v. fluid administration, control of body temperature, nausea and vomit prophylaxis, multimodal approach to opioid-sparing pain control, restrictive use of surgical drains, laparoscopic surgery, removal of nasogastric tubes before reversal of anesthesia, early removal of urinary catheter, early mobilization, early oral intake of fluids and solids, use of chewing gums and laxatives, intake of protein-rich nutritional supplements, prepare for early discharge, audit).
Endpoints
1. Anastomotic leakage rate
2. Minor and major complications
3. Length of postoperative hospital stay
4. Readmission and reoperation rates Recorded data and follow-up Potential patient-specific and intraoperative risk factors will be recorded: gender, body mass index, nutritional status according to the Mini Nutritional Assessment short-form, surgical indication (cancer, polyps, chronic inflammatory bowel disease, diverticular disease), preoperative albuminemia, use of steroids, renal failure and dialysis, cardiovascular or respiratory disease, American Society of Anesthesia class, bowel preparation (decision made by operating surgeon), laparoscopy or laparotomy, level of anastomosis and technique (mechanical or hand-sewn, intra- or extra-corporeal), operative time, presence of drainage, and perioperative blood transfusion(s). During the postoperative period, patients will be examined by the attending surgeon daily. Fever (central temperature \> 38 °C), pulse, abdominal signs, bowel movements, volume and aspect of drainage (if present) will be recorded daily. The attending surgeon will make any decision for complementary exams and imaging according to his own criteria. The rate of any complication will be calculated and graded including all leaks (independently of clinical significance), wound infection (according to the definitions of the Centers for Disease Control and Prevention and wound culture), pneumonia (clinical symptoms, and physical and radiological examinations), central line infection (positive blood culture), urinary tract infection (positive urine culture with bacterial count ). Patients will be followed-up in the outpatient clinic up to 6 weeks after discharge from the hospital.
Main endpoint is anastomotic dehiscence (intended as any deviation from the planned postoperative course related to the anastomosis, or presence of pus or enteric contents within the drains, presence of abdominal or pelvic collection in the area of the anastomosis on postoperative CT scan, performed at the discretion of the attending surgeon, leakage of contrast through the anastomosis during enema or evident anastomotic dehiscence at reoperation for postoperative peritonitis). Thus, all detected leaks will be considered independently of clinical significance. No imaging will be performed routinely in order to search for leakage.
Secondary endpoints are morbidity and mortality rates, postoperative length of stay, readmission and reoperation rates.
After anonymization, all data of each single case will be prospectively uploaded by every local investigator on a protected web-based database. Thereafter, all data will be incorporated into a spreadsheet (MS Excel) for data analysis, checking for any discrepancy, that will be addressed and solved through strict cooperation between chief investigator, data manager and participating center.
Statistical Analysis Quantitative values will be expressed as mean ± standard deviation, median and range; categorical data with percentage frequencies. Mean values of duration of stay will be compared according to the presence or absence of fistulas using Student's two-sided t test (allowing for heterogeneity of variances) or with a non-parametric Mann-Whitney test. Both univariate analysis and multivariate analysis will be performed to assess risk factors for leakage and overall complications. The odds ratio (OR) will be presented followed by its 95% confidence interval (95% CI). For all statistical tests the significant level is fixed at p \< .05.
Statistical analyses will be carried out using STATA software (Stata Corp. College Station, Texas, USA).
Sample size Considering that adherence to 70% of the items of an ERAS program determines a significant reduction in surgical complications after colorectal surgery, an estimation of the OR for AL and ERAS program adherence at 70% of the items is equal to 0.55 (95% c.i. 0.36-0.87); assuming a maximum error equal to 0.04, the required sample size is n=1,748 (about 874 cases per arm expected in low vs high adherence to ERAS programs).
Anastomotic leakage (AL) is a dreaded major complication after colorectal surgery. The overall incidence of anastomotic dehiscence and subsequent leaks is 2 to 7 percent when performed by experienced surgeons. The lowest leak rates are found with ileocolic anastomoses (1 to 3 percent) and the highest occur with coloanal anastomosis (10 to 20 percent). Leaks usually become apparent between five and seven days postoperatively. Almost half of all leaks occur after the patient has been discharged, and up to 12 percent occur after postoperative day (POD) 30. Late leaks often present insidiously with low-grade fever, prolonged ileus, and nonspecific symptoms attributable to other postoperative infectious complications. Small, contained leaks present later in the clinical course and may be difficult to distinguish from postoperative abscesses by radiologic imaging, making the diagnosis uncertain and underreported.
There is no uniform definition of an anastomotic dehiscence and leak. In a review of 97 studies, as an example, 56 different definitions of an anastomotic leak were used. The majority of reports define an anastomotic leak using clinical signs, radiographic findings, and intraoperative findings. The clinical signs include: Pain, Fever, Tachycardia, Peritonitis, Feculent drainage, Purulent drainage. The radiographic signs include: Fluid collections, Gas containing collections. The intraoperative findings include: Gross enteric spillage, Anastomotic disruption.
Risk factors for a dehiscence and leak are classified according to the site of the anastomosis (extraperitoneal or intraperitoneal). A prospective review of 1598 patients undergoing 1639 anastomotic procedures for benign or malignant colorectal disease found a significantly increased risk of anastomotic leak with extraperitoneal compared with intraperitoneal anastomoses (6.6 versus 1.5 percent; 2.4 percent overall).
Major risk factors for an extraperitoneal AL include: The distance of the anastomosis from the anal verge (Patients with a low anterior resection and an anastomosis within 5 cm from the anal verge are the highest risk group for an anastomotic leak), Anastomotic ischemia, Male gender, Obesity.
Major risk factors for an intraperitoneal AL include: American Society of Anesthesiologists (ASA) score Grade III to V, Emergent surgery, Prolonged operative time, Hand-sewn ileocolic anastomosis.
Controversial, inconclusive, or pertinent negative associations between the following variables and AL have been reported: Neoadjuvant radiation therapy, Drains, Protective stoma, Hand-sewn colorectal anastomosis, Laparoscopic procedure, Mechanical bowel preparation, Nutritional status, Perioperative corticosteroids.
Enhanced Recovery After Surgery (ERAS) programs for colorectal surgery have been extensively studied during the last 20 years. It is now clear that they offer a consistent reduction of overall morbidity rates, postoperative length of stay and costs, and that there is a clear dose-effect relation between adherence to at least 60-70% of the program items and these outcomes. On the other hand, little is known concerning the potential benefit of ERAS programs over AL rates or if adherence to specific items of the program may reduce AL rates.
Therefore, the investigators planned this study to prospectively evaluate AL rates after colorectal resections and their interaction with known risk factors and ERAS program items.
METHODS
Prospective enrollment from January to December 2019 in 41 Italian surgical centers. All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after having provided a written informed consent. A total of 1,750 patients is expected based on a mean of 43 cases/year per center.
Outcome measures
1. Preoperative risk factors of anastomotic leakage (age, gender, obesity, nutritional status, diabetes, cardiovascular disease, chronic liver disease, renal failure, inflammatory bowel disease, perioperative steroid therapy, ASA class I-II vs III)
2. Operative parameters (approach, procedure, anastomotic technique, length of operation, disease stage)
3. ERAS program items (prehabilitation, counseling, nutritional evaluation, immuno-nutrition, deep venous thrombosis prophylaxis, antibiotic prophylaxis, bowel preparation, preoperative carbohydrates load, standardized anesthesia protocol, restrictive i.v. fluid administration, control of body temperature, nausea and vomit prophylaxis, multimodal approach to opioid-sparing pain control, restrictive use of surgical drains, laparoscopic surgery, removal of nasogastric tubes before reversal of anesthesia, early removal of urinary catheter, early mobilization, early oral intake of fluids and solids, use of chewing gums and laxatives, intake of protein-rich nutritional supplements, prepare for early discharge, audit).
Endpoints
1. Anastomotic leakage rate
2. Minor and major complications
3. Length of postoperative hospital stay
4. Readmission and reoperation rates Recorded data and follow-up Potential patient-specific and intraoperative risk factors will be recorded: gender, body mass index, nutritional status according to the Mini Nutritional Assessment short-form, surgical indication (cancer, polyps, chronic inflammatory bowel disease, diverticular disease), preoperative albuminemia, use of steroids, renal failure and dialysis, cardiovascular or respiratory disease, American Society of Anesthesia class, bowel preparation (decision made by operating surgeon), laparoscopy or laparotomy, level of anastomosis and technique (mechanical or hand-sewn, intra- or extra-corporeal), operative time, presence of drainage, and perioperative blood transfusion(s). During the postoperative period, patients will be examined by the attending surgeon daily. Fever (central temperature \> 38 °C), pulse, abdominal signs, bowel movements, volume and aspect of drainage (if present) will be recorded daily. The attending surgeon will make any decision for complementary exams and imaging according to his own criteria. The rate of any complication will be calculated and graded including all leaks (independently of clinical significance), wound infection (according to the definitions of the Centers for Disease Control and Prevention and wound culture), pneumonia (clinical symptoms, and physical and radiological examinations), central line infection (positive blood culture), urinary tract infection (positive urine culture with bacterial count ). Patients will be followed-up in the outpatient clinic up to 6 weeks after discharge from the hospital.
Main endpoint is anastomotic dehiscence (intended as any deviation from the planned postoperative course related to the anastomosis, or presence of pus or enteric contents within the drains, presence of abdominal or pelvic collection in the area of the anastomosis on postoperative CT scan, performed at the discretion of the attending surgeon, leakage of contrast through the anastomosis during enema or evident anastomotic dehiscence at reoperation for postoperative peritonitis). Thus, all detected leaks will be considered independently of clinical significance. No imaging will be performed routinely in order to search for leakage.
Secondary endpoints are morbidity and mortality rates, postoperative length of stay, readmission and reoperation rates.
After anonymization, all data of each single case will be prospectively uploaded by every local investigator on a protected web-based database. Thereafter, all data will be incorporated into a spreadsheet (MS Excel) for data analysis, checking for any discrepancy, that will be addressed and solved through strict cooperation between chief investigator, data manager and participating center.
Statistical Analysis Quantitative values will be expressed as mean ± standard deviation, median and range; categorical data with percentage frequencies. Mean values of duration of stay will be compared according to the presence or absence of fistulas using Student's two-sided t test (allowing for heterogeneity of variances) or with a non-parametric Mann-Whitney test. Both univariate analysis and multivariate analysis will be performed to assess risk factors for leakage and overall complications. The odds ratio (OR) will be presented followed by its 95% confidence interval (95% CI). For all statistical tests the significant level is fixed at p \< .05.
Statistical analyses will be carried out using STATA software (Stata Corp. College Station, Texas, USA).
Sample size Considering that adherence to 70% of the items of an ERAS program determines a significant reduction in surgical complications after colorectal surgery, an estimation of the OR for AL and ERAS program adherence at 70% of the items is equal to 0.55 (95% c.i. 0.36-0.87); assuming a maximum error equal to 0.04, the required sample size is n=1,748 (about 874 cases per arm expected in low vs high adherence to ERAS programs).
Conditions
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Colorectal Neoplasms
Anastomotic Leak
Surgery--Complications
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
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Colorectal resections
Colorectal resections
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
1. Patients submitted to laparoscopic/robotic/open/converted ileo-colo-rectal resection with anastomosis (both intra- and extra-corporeal), including planned Hartmann's reversals.
2. American Society of Anesthesiologists' (ASA) class I, II or III
3. Elective or delayed urgency surgery
4. Patients' written acceptance to be included in the study.
2. American Society of Anesthesiologists' (ASA) class I, II or III
3. Elective or delayed urgency surgery
4. Patients' written acceptance to be included in the study.
Exclusion Criteria
1. American Society of Anesthesiologists' (ASA) class IV-V
2. Patients with stoma before or at operation
3. Simple stoma closure
4. Transanal procedure
5. Pregnancy
6. Hyperthermic intraperitoneal chemotherapy for carcinomatosis.
2. Patients with stoma before or at operation
3. Simple stoma closure
4. Transanal procedure
5. Pregnancy
6. Hyperthermic intraperitoneal chemotherapy for carcinomatosis.
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ospedale C & G Mazzoni
OTHER
Sponsor Role
lead
Responsible Party
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Marco Catarci
Director, General Surgery Unit
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Marco Catarci, MD FACS
Role: STUDY_CHAIR
Ospedale C & G Mazzoni - Ascoli Piceno
Gianluca Guercioni, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale C & G Mazzoni - Ascoli Piceno
Locations
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UOC Chirurgia Generale - Ospedale Profili - Fabriano (AN) - ASUR MARCHE AV2
Fabriano, AN, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Ospedale "C. Urbani" Jesi - AV2 - ASUR Marche
Iesi, AN, Italy
Site Status
RECRUITING
UOC Chirurgia Generale e d'Urgenza - Ospedale Regionale "U. Parini" - Aosta
Aosta, AO, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Ascoli Piceno - AV5 - ASUR Marche
Ascoli Piceno, AP, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - San Benedetto del Tronto (AP) - AV5 - ASUR Marche
San Benedetto del Tronto, AP, Italy
Site Status
RECRUITING
UOC Chirurgia Generale Universitaria - Ospedale San Salvatore - L'Aquila
L’Aquila, AQ, Italy
Site Status
RECRUITING
UOC Chirurgia Oncologica - AORN San Giuseppe Moscati - Avellino
Avellino, AV, Italy
Site Status
RECRUITING
Clinica Chirurgica, Università di Brescia - UOC Chirurgia Generale 3, ASST Spedali Civili di Brescia - Brescia
Brescia, BS, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Ospedale Montichiari (BS) - ASST Spedali Civili di Brescia
Montichiari, BS, Italy
Site Status
RECRUITING
S.C. Chirurgia Generale e Oncologica - Azienda Ospedaliera S. Croce e Carle - Cuneo, Italia
Cuneo, CN, Italy
Site Status
RECRUITING
UOC Chirurgia Generale 1 - Chirurgia laparoscopica - Università di Ferrara
Ferrara, FE, Italy
Site Status
RECRUITING
UOC di Chirurgia Addominale IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo - Foggia
San Giovanni Rotondo, FG, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Ospedale S. Maria Annunziata - Firenze - ASL Toscana Centro
Florence, FI, Italy
Site Status
RECRUITING
UOC Chirurgia Generale ad Indirizzo Oncologico - IRCCS San Martino IST - Genova
Genova, GE, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Ospedale"San Giovanni di Dio", ASP di Crotone (KR)
Crotone, KR, Italy
Site Status
RECRUITING
UOC Chirurgia Generale e d'Urgenza - Ospedale Cardinale Panico - Tricase (LE)
Tricase, LE, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - ASST Nord - Sesto San Giovanni (MI)
Sesto San Giovanni, MI, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Ospedale di Esine (BS) - ASST Valcamonica
Esine, NS, Italy
Site Status
RECRUITING
UOC Chirurgia Generale e D'Urgenza - Pescara
Pescara, PE, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Foligno (PG) - USL UMBRIA 2
Foligno, PG, Italy
Site Status
RECRUITING
SC Chirurgia Generale e Oncologica - AO Marche Nord - Pesaro
Pesaro, PU, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Ragusa
Ragusa, RG, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Ospedale "Regina Apostolorum" Albano Laziale (RM)
Albano Laziale, RM, Italy
Site Status
RECRUITING
UOC Chirurgia Generale e d'Urgenza - Policlinico Casilino - Roma
Roma, RM, Italy
Site Status
RECRUITING
UOC Chirurgia Generale e D'Urgenza . Azienda Ospedaliera San Camillo Forlanini Roma
Roma, RM, Italy
Site Status
RECRUITING
UOC Chirurgia Generale e Oncologica - Ospedale San Filippo Neri - ASL Roma1
Roma, RM, Italy
Site Status
RECRUITING
UOS Chirurgia Geriatrica - Università Campus BioMedico - Roma
Roma, RM, Italy
Site Status
RECRUITING
UOSD Chirurgia Mininvasiva e dell'Apparato Digerente - Università Tor Vergata - Roma
Roma, RM, Italy
Site Status
RECRUITING
UOC Chirurgia Generale, Ospedale "Ceccarini" di Riccione (RN)
Riccione, RN, Italy
Site Status
RECRUITING
UOC Chirurgia Generale e d'urgenza, Rimini, Novafeltria, Santarcangelo
Rimini, RN, Italy
Site Status
RECRUITING
UOC Chirurgia Generale I - Ospedale di La Spezia - ASL5 Spezzino
La Spezia, SP, Italy
Site Status
RECRUITING
UOC Chirurgia Generale 1 - Ospedale S. Chiara - APSS Trento
Trento, TN, Italy
Site Status
RECRUITING
UOC Chirurgia Generale e Mininvasiva, Ospedale San Camillo di Trento
Trento, TN, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Ospedale "E. Agnelli" di Pinerolo (TO) - ASL TO3
Pinerolo, TO, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Conegliano Veneto (TV) AULSS2 Marca trevigiana
Conegliano, TV, Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Ospedale Sacro Cuore Don Calabria Negrar Verona
Negrar, VR, Italy
Site Status
RECRUITING
U.O.C. di Chirurgia Generale e dell'Esofago e Stomaco - AOUI di Verona
Verona, VR, Italy
Site Status
RECRUITING
UOC Chirurgia Generale Epatobiliare - AOUI Verona
Verona, VR, Italy
Site Status
RECRUITING
UOC Chirurgia Generale Oncologica - Azienda Ospedaliera Belcolle - Viterbo
Viterbo, VT, Italy
Site Status
RECRUITING
SOC Chirurgia Colorettale - Istituto Nazionale dei Tumori - IRCCS Fondazione "G.Pascale" - Napoli
Napoli, , Italy
Site Status
RECRUITING
UOC Chirurgia Generale - Pozzuoli (NA) - ASL Napoli2 nord
Pozzuoli, , Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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Facility Contacts
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Augusto Verzelli, MD
Role: primary
Roberto Campagnacci, MD
Role: primary
Paolo Millo, MD
Role: primary
Gianluca Guercioni, MD
Role: primary
Walter Siquini, MD
Role: primary
Stefano Guadagni, MD
Role: primary
Francesco Crafa, MD
Role: primary
Gian Luca Baiocchi, MD
Role: primary
Nereo Vettoretto, MD
Role: primary
FELICE BORGHI
Role: primary
Gabriele Anania, MD
Role: primary
Matteo Scaramuzzi, MD
Role: primary
Marco Scatizzi, MD
Role: primary
STEFANO SCABINI, MD
Role: primary
Giuseppe Brisinda, MD
Role: primary
Massimo G Viola, MD
Role: primary
Gianandrea Baldazzi, MD
Role: primary
Lucio Taglietti, MD
Role: primary
Massimo Basti, MD
Role: primary
Graziano Ceccarelli, MD
Role: primary
Alberto Patriti, MD
Role: primary
Gianluca Di Mauro, MD
Role: primary
Andrea Liverani, MD
Role: primary
Graziano Longo, MD
Role: primary
Pierluigi Marini, MD
Role: primary
Stefano Mancini, MD
Role: primary
Marco Caricato, MD
Role: primary
Giuseppe S Sica, MD
Role: primary
Andrea Lucchi, MD
Role: primary
Gianluca Garulli, MD
Role: primary
Stefano Berti, MD
Role: primary
Alessandro Carrara, MD
Role: primary
Alberto Di Leo, MD
Role: primary
Andrea Muratore, MD
Role: primary
Maurizio Pavanello, MD
Role: primary
GIACOMO RUFFO, MD
Role: primary
Alberto Di Leo, MD
Role: primary
Corrado Pedrazzani, MD
Role: primary
Raffaele Macarone Palmieri, MD
Role: primary
PAOLO DEL RIO, MD
Role: primary
Felice Pirozzi, MD
Role: primary
References
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Boushey R, Williams LJ. Management of anastomotic complications of colorectal surgery. Uptodate 2017.
Reference Type
BACKGROUND
Slieker JC, Komen N, Mannaerts GH, Karsten TM, Willemsen P, Murawska M, Jeekel J, Lange JF. Long-term and perioperative corticosteroids in anastomotic leakage: a prospective study of 259 left-sided colorectal anastomoses. Arch Surg. 2012 May;147(5):447-52. doi: 10.1001/archsurg.2011.1690.
Reference Type
BACKGROUND
Kingham TP, Pachter HL. Colonic anastomotic leak: risk factors, diagnosis, and treatment. J Am Coll Surg. 2009 Feb;208(2):269-78. doi: 10.1016/j.jamcollsurg.2008.10.015. Epub 2008 Dec 4. No abstract available.
Reference Type
BACKGROUND
Hyman N, Manchester TL, Osler T, Burns B, Cataldo PA. Anastomotic leaks after intestinal anastomosis: it's later than you think. Ann Surg. 2007 Feb;245(2):254-8. doi: 10.1097/01.sla.0000225083.27182.85.
Reference Type
BACKGROUND
Park JS, Choi GS, Kim SH, Kim HR, Kim NK, Lee KY, Kang SB, Kim JY, Lee KY, Kim BC, Bae BN, Son GM, Lee SI, Kang H. Multicenter analysis of risk factors for anastomotic leakage after laparoscopic rectal cancer excision: the Korean laparoscopic colorectal surgery study group. Ann Surg. 2013 Apr;257(4):665-71. doi: 10.1097/SLA.0b013e31827b8ed9.
Reference Type
BACKGROUND
Dietz, DW, Bailey, HR. Postoperative complications. In: ASCRS Textbook of Colon and Rectal Surgery, Church, JM, Beck, DE, Wolff, BG, Fleshman, JW, Pemberton, JH, (Eds), Springer-Verlag New York, LLC, New York 2006. p.141.
Reference Type
BACKGROUND
Bruce J, Krukowski ZH, Al-Khairy G, Russell EM, Park KG. Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Br J Surg. 2001 Sep;88(9):1157-68. doi: 10.1046/j.0007-1323.2001.01829.x.
Reference Type
BACKGROUND
Law WI, Chu KW, Ho JW, Chan CW. Risk factors for anastomotic leakage after low anterior resection with total mesorectal excision. Am J Surg. 2000 Feb;179(2):92-6. doi: 10.1016/s0002-9610(00)00252-x.
Reference Type
BACKGROUND
Lipska MA, Bissett IP, Parry BR, Merrie AE. Anastomotic leakage after lower gastrointestinal anastomosis: men are at a higher risk. ANZ J Surg. 2006 Jul;76(7):579-85. doi: 10.1111/j.1445-2197.2006.03780.x.
Reference Type
BACKGROUND
Platell C, Barwood N, Dorfmann G, Makin G. The incidence of anastomotic leaks in patients undergoing colorectal surgery. Colorectal Dis. 2007 Jan;9(1):71-9. doi: 10.1111/j.1463-1318.2006.01002.x.
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
Ljungqvist O, Thanh NX, Nelson G. ERAS-Value based surgery. J Surg Oncol. 2017 Oct;116(5):608-612. doi: 10.1002/jso.24820. Epub 2017 Sep 5.
Reference Type
BACKGROUND
Nelson G, Kiyang LN, Crumley ET, Chuck A, Nguyen T, Faris P, Wasylak T, Basualdo-Hammond C, McKay S, Ljungqvist O, Gramlich LM. Implementation of Enhanced Recovery After Surgery (ERAS) Across a Provincial Healthcare System: The ERAS Alberta Colorectal Surgery Experience. World J Surg. 2016 May;40(5):1092-103. doi: 10.1007/s00268-016-3472-7.
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BACKGROUND
Neville A, Lee L, Antonescu I, Mayo NE, Vassiliou MC, Fried GM, Feldman LS. Systematic review of outcomes used to evaluate enhanced recovery after surgery. Br J Surg. 2014 Feb;101(3):159-70. doi: 10.1002/bjs.9324.
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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.
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BACKGROUND
Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
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BACKGROUND
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
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BACKGROUND
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
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BACKGROUND
Kaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony P, Charlton KE, Maggio M, Tsai AC, Grathwohl D, Vellas B, Sieber CC; MNA-International Group. Validation of the Mini Nutritional Assessment short-form (MNA-SF): a practical tool for identification of nutritional status. J Nutr Health Aging. 2009 Nov;13(9):782-8. doi: 10.1007/s12603-009-0214-7.
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BACKGROUND
Skipper A, Ferguson M, Thompson K, Castellanos VH, Porcari J. Nutrition screening tools: an analysis of the evidence. JPEN J Parenter Enteral Nutr. 2012 May;36(3):292-8. doi: 10.1177/0148607111414023. Epub 2011 Nov 1.
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BACKGROUND
Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8. No abstract available.
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BACKGROUND
Catarci M, Ruffo G, Viola MG, Garulli G, Pavanello M, Scatizzi M, Bottino V, Guadagni S; Italian ColoRectal Anastomotic Leakage (iCral) study group. Enhanced Recovery Independently Lowers Failure to Rescue After Colorectal Surgery. Dis Colon Rectum. 2025 May 1;68(5):616-626. doi: 10.1097/DCR.0000000000003655. Epub 2025 Feb 11.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2.0
Identifier Type: -
Identifier Source: org_study_id