Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)

NCT ID: NCT03629626

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2021-12-31

Brief Summary

Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.

Detailed Description

The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.

Conditions

Gynecologic Disease; Gynecologic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Perioperative (SP) care

Conventional Perioperative (SP) care

Group Type: NO_INTERVENTION

No interventions assigned to this group

ERAS protocol

preoperative / intraoperative/ postoperative management

Group Type: EXPERIMENTAL

ERAS protocol

Intervention Type: PROCEDURE

preoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling

intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.

postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV.

It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function.

Interventions

ERAS protocol

preoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling

intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.

postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV.

It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age >18 and <70 years old
• Patients candidated for elective gynecological surgery for benign pathology
• Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery
• Signed consent form

Exclusion Criteria

• Contraindication to loco-regional anaesthesia
• Patients with ileus or subocclusive condition prior surgery
• Coagulation disorders
• Organ failure or severe disfunction (heart, renal, pulmonary, hepatic)
• Uncontrolled hypertension (>180/95)
• Alcohol or drug abuser (current or previous)
• Psychiatric condition or language barriers
• Planned Intensive Care Recovery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Beihua Kong

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beihua Kong, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Countries

China

References

Xing N, Wang H, Huang Y, Peng J. Enhanced recovery after surgery program alleviates neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio in patients undergoing gynecological surgery. Front Med (Lausanne). 2023 Apr 17;10:1057923. doi: 10.3389/fmed.2023.1057923. eCollection 2023.

Reference Type: DERIVED

PMID: 37138751 (View on PubMed)

Peng J, Dong R, Jiao J, Liu M, Zhang X, Bu H, Dong P, Zhao S, Xing N, Feng S, Yang X, Kong B. Enhanced Recovery After Surgery Impact on the Systemic Inflammatory Response of Patients Following Gynecological Oncology Surgery: A Prospective Randomized Study. Cancer Manag Res. 2021 Jun 1;13:4383-4392. doi: 10.2147/CMAR.S294718. eCollection 2021.

Reference Type: DERIVED

PMID: 34103993 (View on PubMed)

Other Identifiers

ERASGS-01

Identifier Type: -

Identifier Source: org_study_id