FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
NIL 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar- 751019 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
Close