| CTRI Number |
CTRI/2026/02/103337 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
ROLE OF MECHANICAL BOWEL PREPARATION WITH ORAL ANTIBIOTICS IN COLORECTAL SURGERIES |
|
Scientific Title of Study
|
Combined Oral Antibiotics with Mechanical Bowel Preparation Outcomes in Colorectal Surgery- A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
COMBO-CRS Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammed Fahim Ali A |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of General Surgery
Indira Gandhi Medical College
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
09600207610 |
| Fax |
|
| Email |
a.fahimali26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Mahajan |
| Designation |
Professor and Head Department of General Surgery |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of General Surgery
Indira Gandhi Medical College
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418151939 |
| Fax |
|
| Email |
Puneetdr1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammed Fahim Ali A |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of General Surgery
Indira Gandhi Medical College
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
09600207610 |
| Fax |
|
| Email |
a.fahimali26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College, Shimla, Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College |
| Address |
Indira Gandhi Medical College
Shimla
Himachal Pradesh
pin code-171001 |
| 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 |
| Mohammed Fahim Ali A |
Indira Gandhi Medical College |
Department of General Surgery
Indira Gandhi Medical College
Shimla
171001
Shimla
HIMACHAL PRADESH |
09600207610
a.fahimali26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INDIRA GANDHI MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mechanical bowel preparation with Oral Antibiotics |
2L POLYETHYLENE GLYCOL to be taken at 1800 h
Oral METRONIDAZOLE 2G at 1900 h and oral RIFAXIMIN 550 MG at 2200 h
|
| Comparator Agent |
Mechanical bowel preparation with placebo |
2L POLYETHYLENE GLYCOL to be taken at 1800 h
Oral placebo at 1900 h and oral placebo at 2200 h
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All Patients requiring colorectal surgery |
|
| ExclusionCriteria |
| Details |
Patient not willing for the study
Emergency surgeries
Patients who did not follow the designated protocol due to medical contraindications
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of SSIs |
any time up to 30 days postoperative period and up to discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Length of hospital stay
|
upto discharge from hospital |
| Time to return to normal activities |
upto discharge from hospital & 30 days postoperative period |
| Anastomotic leakage |
upto discharge from the hospital & 30 days postoperative period |
| Postop ileus |
upto discharge from the hospital & 30 days postoperative period |
| Mortality |
upto discharge from the hospital & 30 days postoperative period |
| Readmission rates |
upto discharge from the hospital & 30 days postoperative period |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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 4 |
|
Date of First Enrollment (India)
|
19/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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
|
There are many studies worldwide on Mechanical bowel preparation and oral antibiotics (MOAB). Different authors have varied opinions about the use of bowel preparation and antibiotics before colorectal surgeries. In this study, we aim to identify the advantages of Mechanical bowel preparation when combined with oral antibiotics compared with Mechanical bowel preparation alone. A combination of antibiotics along with MBP could improve postoperative outcomes by reducing the risk of infections in colorectal cancer surgeries. Hence, benefiting the patient in postoperative recovery. |