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

ConditionsERASCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients between the age of 18-70 years,

diagnosed case with cervical, uterine or ovarian cancer,

Admitted for surgical management .

Disqualifiers

Patients with severe comorbidity, including DM,CRD,CLD

patients with American Society of Anesthesiologists risk ≥ 4,

severe organ dysfunction or failure.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ERAS protocol

    Procedure/Surgery

    Procedure: ERAS protocol

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: ERAS groupExperimental treatment 1 intervention
Group B: Conventional GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

hospital stay

duration of hospital stay in ERAS group

Time frame
3 to 4 days

Secondary outcomes

1

Day of first flatus

day of first flatus

Time frame
upto 24 hours
2

postoperative nausea and vomiting

frequency of postoperative nausea and vomiting

Time frame
upto 24 hours
3

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

pain score from the scale that is higher score indicate worse and lower score indicate good

Time frame
upto 48 hours
4

complications related to the intervention

yes or no

Time frame
upto 2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Lead sponsor

Source ClinicalTrials.gov
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