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

StatusRecruiting
PhaseNot applicable
Started2025-06-01
View on ClinicalTrials.gov ↗

Amendment history

2025-08-02
Study Status, Outcome Measures v3
Secondary endpoints7 entries, revised
pain score by the visual analogue scale with score fromminimum 0 toand maximum 10
2025-07-30
Study Status, Outcome Measures v2
Secondary endpointsdetails revised at 1 of 7 entries
2025-07-28
Study Status, Study Description, Outcome Measures, Eligibility v1
Eligibility criteria-10 characters
Inclusion Criteria: 1. Patients between the age of 18-70 years, 2. diagnosed case with cervical, uterine or ovarian cancer, 3. Admitted for surgical management . - Exclusion Criteria: Patients with severe comorbidity, includ [...] thesiologists risk ≥ 4, severe organ dysfunction or failure. -
Secondary endpoints7 entries, revised
pain score by the visual analogue scale with score from 0 to 10
Study description-36 characters
Over 234 million major surgical procedures are performed globally each year1year and despite advances in surgical and anaesthetic care, morbidity after abdominal surgery is still high.2 Fasttrack or enhanced recovery after surgery (ERAS) clinica [...] f functional capacity and accelerating the recovery process.3 The ERAS pathways reduce the delay until full recovery afte [...] nes for ERAS in gynecologic oncology were published in 2019.4 Components of ERAS are preoperative, intraoperative and pos [...] y and intake of clear fluids until 2 hours prior to surgery.5 A Cochrane review reported that preoperative carboh [...] [...]
2025-07-24
Original filing
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).
Trial Details
NCT Number NCT07087366
Lead Sponsor Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Conditions ERAS, Cancer
Enrollment 130 participants
Start Date 2025-06-01
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-07