| CTRI Number |
CTRI/2026/02/104800 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of thorough saline washing following surgery for abdominal cancer on postoperative outcome |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dripta Ramya Sahoo |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Surgical Oncology, 3rd floor, AIIMS Bhubaneswar AIIMS Bhubaneswar, Sijua, Patrapada Khordha ORISSA 751019 India |
| Phone |
8547726737 |
| Fax |
|
| Email |
dripta@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Phanindra Kumar Swain |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Surgical Oncology, AIIMS Bhubaneswar AIIMS Bhubaneswar, Sijua, Patrapada Khordha ORISSA 751019 India |
| Phone |
8547726737 |
| Fax |
|
| Email |
pkskrzzy123@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Phanindra Kumar Swain |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Surgical Oncology, AIIMS Bhubaneswar AIIMS Bhubaneswar, Sijua, Patrapada Khordha ORISSA 751019 India |
| Phone |
8547726737 |
| Fax |
|
| Email |
pkskrzzy123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar- 751019 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dripta Ramya Sahoo |
AIIMS Bhubaneswar |
Department of Surgical Oncology, I+3, 3rd floor, AIIMS Bhubaneswar Sijua Patrapada Odisha- 751019 Khordha ORISSA |
08547726737
dripta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extended Intraperitoneal lavage |
Patients who will undergo extended intraoperative peritoneal lavage using warmed normal isotonic saline. 5 cycles of 1 L saline will be instilled and suctioned (5L) across the peritoneal cavity, ensuring distribution to subphrenic, paracolic gutters and pelvis, with final suction to dryness. |
| Comparator Agent |
Standard Lavage |
Patients who will undergo standard suction and irrigation as per routine practice (no systematic large-volume lavage). Small-volume irrigation will be allowed for haemostasis or visualization at surgeon’s discretion but no intentional large-volume lavage protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
Pre-existing peritonitis
Bowel Perforation
Gross Intraoperative Spillage
Bowel Obstruction
Uncontolled Diabetes
Renal, Liver, Heart failure
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of extended intra-operative peritoneal lavage on time to first bowel movement in hours (passage of stools) after elective oncologic abdominal surgery |
At baseline, first week post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of extended intraoperative peritoneal lavage on
Incidence of surgical site infection within 30 days postoperatively
Time to first flatus in hours
Overall postoperative complication rate within 30 days
Length of hospital stay in days
Readmission within 30 days
Postoperative pain scores, VAS score at 24, 48 hours
Post operative inflammatory markers like CRP, Procalcitonin |
At Baseline, at first week, at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="126" Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |