| CTRI Number |
CTRI/2025/08/093343 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
How surgical closure techniques affect recovery after emergency abdominal surgery |
|
Scientific Title of Study
|
Assessing the outcome of fascial closure techniques on wound complications in emergency laparotomy : A three-arm randomized controlled 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 |
Garima |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of general surgery , AIIMS Bathinda
4th floor
C and D block
PUNJAB
151001
India |
| Phone |
8683910286 |
| Fax |
|
| Email |
rajranik111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahendra Pratap Singh |
| Designation |
Head of department |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of general surgery, AIIMS Bathinda
4 th floor
C and D block
Bathinda
PUNJAB
151001
India |
| Phone |
9407549239 |
| Fax |
|
| Email |
drmpsingh2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahendra Pratap Singh |
| Designation |
Head of department |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of general surgery, AIIMS Bathinda
4 th floor
C and D block
Bathinda
PUNJAB
151001
India |
| Phone |
9407549239 |
| Fax |
|
| Email |
drmpsingh2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences , ,Bathinda , India, 151001
|
|
|
Primary Sponsor
|
| Name |
AIIMS Bathinda |
| Address |
All India Institute of Medical Sciences, Bathinda , India, 151001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Garima |
AIIMS Bathinda |
Department of general surgery,
4 th floor
C and D block
AIIMS Bathinda
AIIMS Bathinda
Bathinda
PUNJAB |
8683910286
rajranik111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K565||Intestinal adhesions [bands] withobstruction (postinfection), (2) ICD-10 Condition: K271||Acute peptic ulcer, site unspecified, with perforation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continuous large bite |
10 mm using PDS No. 1 double loop |
| Intervention |
Continuous small bite |
5 mm using PDS No 1 double loop |
| Intervention |
Interrupted large bite suture |
10 mm using PDS No.1 single loop |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing primary closure of fascial incision |
|
| ExclusionCriteria |
| Details |
History of previous laparotomy
Pregnant/ lactating female
Patient with metastatic cancer with chemotherapy within 14 days prior to surgery
Patients with history of abdominal radiotherapy or chemotherapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of surgical site infection in different fascial closure techniques |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time each technique takes per cm fascial wound closure |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="252"
Sample Size from India="252"
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 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
assessing the outcome of fascial closure techniques on wound complications in emergency laparotomy: a three-arm randomised controlled trial Intervention arm continuous small bite suture and interrupted large bite suture Control arm continuous large bite suture Primary objective is to compare the incidence of wound complications in different fascial closure techniques and secondary objective is to compare the time each technique takes per cm fascial wound closure |