| CTRI Number |
CTRI/2025/06/088133 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare early interrupted double X suture with continuous method for closure of abdominal wall incisions. |
|
Scientific Title of Study
|
Comparison of early outcomes of interrupted double X suture versus continuous far near-near far method for closure of abdominal wall incisions: A double blinded randomised 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 |
Dr Om Prakash |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 405,Surgical Block All India Institute of Medical Sciences, New Delhi.
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
8003991303 |
| Fax |
|
| Email |
Drprajapatiom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Om Prakash |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 405,Surgical Block All India Institute of Medical Sciences, New Delhi.
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
8003991303 |
| Fax |
|
| Email |
Drprajapatiom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arpita |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 208 , hostel 14
All India Institute of Medical Sciences, New Delhi.
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9304835624 |
| Fax |
|
| Email |
arpitamishra34pooja@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical SciencesNew Delhi |
| Address |
All India Institute of Medical Sciences,New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 |
| Dr Om Prakash |
surgery block Aiims new delhi |
Room No. 405,Surgical Block All India Institute of Medical Sciences, New Delhi.
New Delhi
DELHI
110029
India
New Delhi
DELHI |
8003991303
Drprajapatiom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, AIIMS, New Delhi |
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 |
Continuous far near-near far technique |
Abdominal wall closure using loop nylon No.1 with continuous manner |
| Intervention |
Interrupted double X suture |
Abdominal wall closure to be done by interrupted doubles X techniques using Prolene No 1 suture |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age > 18 years
Midline/ non midline incisions ( midline, paramedian, right subcostal, lumbar, pfannensteil ) > five cms in length
Elective / Emergency procedures |
|
| ExclusionCriteria |
| Details |
Age < 18 years
Patients undergoing re-laparotomy
Patients who underwent previous hernia repair
Patients with incisional hernia
Patients with documented collagen vascular diseases
Patients undergoing emergency laparotomy where fascial closure is not possible and requires a mesh laparostomy
Pregnancy
Patients unfit for general anaesthseia
Refusal for consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of burst abdomen following interrupted double ‘X’ suture vs Smead Jones far near - near far continuous method
To compare surgical site infection following interrupted double ‘X’ suture vs Smead Jones far near - near far continuous method |
At time of surgery
1 week
1 month
3 month
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of incisional hernia at the end of six months follow up between interrupted double ‘X’ suture vs Smead Jones far near - near far continuous method
To compare postoperative wound pain between interrupted double ‘X’ suture and Smead Jones far near - near far continuous method at 1 week, 1 month and 3 months using Visual Analog Scoring system of pain |
At 1 week
1 month
3 months |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
23/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/06/2025 |
| 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
|
Double X interrupted suture technique of abdominal wall closure will result in significant reduction in the incidence of burst abdomen, surgical site infection and incisional hernia as compared to continuous closure technique for abdominal wall incisions more than five centimeters (cm) in length.
|