Enhanced Recovery After Surgery(ERAS) Following Gynaecological Oncology Surgery in a Tertiary Level Hospital

NCT07087366 | Recruiting DMC

• 1 other identifier: 1139
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. The principle of ERAS is to optimize the patient's health before surgery, minimize stress to the body, and restore function to normal rapidly by taking steps before, during, and after surgery, to decrease the length of stay in the hospital, reduce recovery time, prevent complications, readmissions, same day discharge (SDD) and patient's satisfaction. The aim of this study is to introduce the ERAS recommendations into the management of gynaecological surgical procedures in compared to conventional procedures. After taking permission from Institutional Review Board (IRB) of BSMMU, the proposed study will be started. After taking informed written consent and matching eligibility criteria, a total 160 patients will be selected in this prospective randomized control study. This study will be conducted in the Department of gynecological oncology, BSMMU for two years from April 2024 to March 2026. There will be two group in this study, patients of Group A will be selected for ERAS protocol from preoperative to postoperative event up to follow up. Patients of Group B will be selected for conventional method. Outcome of both procedure in terms of hospital stay, costs, requirement of analgesia and complications will be compared. Statistical analyses of the results will be obtained by using window-based computer software devised with Statistical Packages for Social Sciences (SPSS-25).

Conditions

ERAS; Cancer

Keywords

RCT

Outcome Measures

Primary Outcomes (1)

• hospital stay

  duration of hospital stay in ERAS group

  3 to 4 days

Secondary Outcomes (7)

• Day of first flatus

  upto 24 hours

• postoperative nausea and vomiting

  upto 24 hours

• pain score by the visual analogue scale with score minimum 0 and maximum 10

  upto 48 hours

• complications related to the intervention

  upto 2 weeks

• readmission rate

  upto 21days

Study Arms (2)

ERAS group

EXPERIMENTAL

Preoperative: * Education * No bowel preparation * Fasting up to 6 h before surgery * Oral carbohydrate solution (50 G in 200 mL water, 2 hours before surgery Day of surgery: * Insertion of Foley catheter * Antiembolic stockings * Fluid restriction (4-5 L) * 0.2% Bupivacaine during incision closure * Sip of water 2 hours later after surgery * Postoperative LMWH injection * Antiembolic stockings * Foley removal as early as possible * Drain removal as early as possible * Ambulation at morning \& continue and encourage ambulation * Fluid restriction (1-2 L * NSAIDs/ Paracetamol bid for 3 days for analgesia IV PCA (Epidural) * Semifluid diet in POD1 * Soft blended diet in POD2

Procedure: ERAS protocol

Conventional Group

NO INTERVENTION

Before and after Surgery: * Bowel preparation * Midnight fasting * Insertion of Foley catheter * Antiembolic stockings * Fluid (5-6L) * Fluid (2L-3L) * Semifluid diet after first flatus Post-operative: * Use of Narcotic analgesia * Prolonged immobilization * NPO till bowel sound * Prolonged catheterization

Interventions

ERAS protocol PROCEDURE

Procedure: ERAS protocol

ERAS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the age of 18-70 years,
• diagnosed case with cervical, uterine or ovarian cancer,
• Admitted for surgical management .

You may not qualify if:

• Patients with severe comorbidity, including DM,CRD,CLD
• patients with American Society of Anesthesiologists risk ≥ 4,
• severe organ dysfunction or failure.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Jannat Ferdous

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• JANNAT FERDOUS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DR.Jannatul Ferdous, professor

CONTACT

01711607919; jannat@bsmmu.edu.bd

Dr.Shaheda Anwar, MBBS,PhD

CONTACT

01791094506; shahedaanwar@bsmmu.edu.bd

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of gynaecological-oncology

Model Details: Patients between the age of 18-70 years, who will diagnosed with cervical tumors, uterine tumors or ovarian tumors, and admitted for surgical management will be eligible for enrollment.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 28, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)