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Clinical Trials/CTRI/2026/02/104800
CTRI/2026/02/104800Not yet recruitingPhase 3

Effect of Extended Peritoneal Lavage on Post operative Outcome in Open Abdominal Surgeries for Gastrointestinal, Hepatopancreatobiliary and Gynecological Malignancies: An Open label Randomized Controlled Trial

AIIMS Bhubaneswar1 site in 1 country126 target enrollmentStarted: March 9, 2026Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Enrollment
126
Locations
1

Study Overview

Brief Summary

Peritoneal lavage following resection has been widely used following surgeries prior to closure of abdomen,  for ensuring hemostasis and removing debris. It has been in practice following hollow viscus perforation but standard volume of lavage has not yet been defined. Though results have been promising in terms of reduction of surgical site infection, there is heterogeneity in terms of volume of lavage, nature of fluid used (normal saline vs antiseptic vs cytotoxic agents), temperature of fluid (warm vs room-temperature) which contribute to differences in outcomes. Most high-quality RCTs focus on gastric cancer. There are limited number of RCTs on impact of routine extended intraoperative lavage (EIPL) in hepatocellular cancer, colorectal, gynecologic and hepatobiliary malignancies. Lastly, most of the previous studies on EIPL in abdominal surgeries for malignancies have focussed on recurrence free survival and disease free survival. The impact on short term outcomes has been less frequently studied. This study aims to assess the impact of extended intraperitoneal lavage on postoperative outcome in surgeries for abdominal malignancies.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Open abdominal oncologic surgery with planned resection (e.g., gastric, colorectal, hepatic resections) under curative intent Complete hemostasis during surgery ASA I, II Willing to provide informed consent.

Exclusion Criteria

  • Pre-existing peritonitis Bowel Perforation Gross Intraoperative Spillage Bowel Obstruction Uncontolled Diabetes Renal, Liver, Heart failure Pregnancy.

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dripta Ramya Sahoo

AIIMS Bhubaneswar

Study Sites (1)

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