| CTRI Number |
CTRI/2025/02/081409 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to study the rates of surgical site infections with intraoperative versus long duration post operative prophylactic antibiotic therapy in class 2 luminal gastrointestinal surgeries |
|
Scientific Title of Study
|
Incidence of surgical site infection rates with intraoperative antibiotic prophylaxis vs long duration post operative prophylactic antibiotic therapy in luminal gastrointestinal surgeries : a non inferiority randomized control trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishika Dhekial Pyrbot |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research , Chandigarh |
| Address |
Department of general surgery ,
5th level , B-block , Nehru Hospital ,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872276653 |
| Fax |
|
| Email |
rdpmatu1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RN Naga Santosh Irrinki |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of general surgery ,
5th level , B-block , Nehru Hospital ,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914492255 |
| Fax |
|
| Email |
narayanairrinki@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rishika Dhekial Pyrbot |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research , Chandigarh |
| Address |
Department of general surgery ,
5th level , B-block , Nehru Hospital ,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872276653 |
| Fax |
|
| Email |
rdpmatu1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of medical Education and Research, Chandigarh, 160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
PGIMER, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr RN Naga Santosh Irrinki |
Post Graduate Institute of Medical Educaiton and Research |
Department of General Surgery, 5th floor , B-block, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
9914492255
narayanairrinki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH , CHANDIGARH, INSTITUTIONAL ETHICS COMMITTEE (INTRAMURAL) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTINUATION OF POST OPERATIVE ANTIBIOTIC THERAPY IN PATIENTS UNDERGOING LUMINAL GASTROINTESTINAL SURGERIES |
All patients undergoing luminal gastrointestinal surgeries will receive prophylactic intra operative antibiotic according to institutional protocol. After the surgery the patients will be divided into case and control group through the use of a sealed envelop method of generated random numbers. The assignments are stratified according to the patient details and were kept in sealed, sequentially numbered envelops until use. The control group will continue to receive post op antibiotic prophylaxis according to the condition of the patient and surgeons discretion. |
| Intervention |
OMISSION OF CONTINUED POST OPERATIVE ANTIBIOTIC THERAPY IN PATIENTS UNDERGOING LUMINAL GASTROINTESTINAL SURGERIES |
All patients undergoing luminal gastrointestinal surgeries will receive prophylactic intra operative antibiotic according to institutional protocol. After the surgery the patients will be divided into case and control group through the use of a sealed envelop method of generated random numbers. The assignments are stratified according to the patient details and were kept in sealed, sequentially numbered envelops until use. The case group will not receive continuation of prophylactic antibiotic therapy . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give consent to be a participant in this study
Patients with at least one month of follow up
Patients undergoing luminal gastrointestinal surgeries in elective settings (open and laparoscopic)
Patients undergoing surgeries of stomach, small bowel and large bowel(colonic)
Patients with class 2 wounds
|
|
| ExclusionCriteria |
| Details |
Patients not consenting to participate in study
Patients who have undergone oesophageal surgeries
Patients requiring ICU admission during post-operative period
Patients who have received blood transfusions during intra-operative period
Patients who develop organ failure (requiring mechanical ventilation, requiring pressure support)
Patients with an open abdomen (intra -op bogota application)
Patients who were operated outside
Patients who are lost to follow up, leaving against medical advice or patients who have absconded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess incidence of surgical site infections in patients receiving intraoperative prophylactic antibiotic dose alone v/s continued post-operative antibiotic prophylaxis |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the post-operative length of stay.
30-day perioperative morbidity and mortality associated with SSI in the two groups.
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/03/2025 |
| 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="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is to assess incidence of surgical site infections in patients receiving intraoperative prophylactic antibiotic dose alone v/s continued post-operative antibiotic prophylaxis and to compare the post-operative length of stay and 30-day perioperative morbidity and mortality associated with SSI in the two groups. The purpose of this study is to assess the need for post operative antibiotic prophylaxis and the associated SSI rates and morbidities and mortality associated in the two groups in class 2 GI luminal study . It has been seen that antibiotics are not required in class 1 wounds |