| CTRI Number |
CTRI/2024/11/077375 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| 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
|
Can the Right Suture Technique Reduce Post Surgery Abdominal Complications? |
|
Scientific Title of Study
|
Abdominal fascial dehiscence in continuous and figure of eight interrupted suture technique for rectus sheath closure following an emergency laparotomy:A 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 |
Dr. Shah Kashish Bhanu |
| Designation |
Academic Junior Resident |
| Affiliation |
Aiims Jodhpur |
| Address |
525,5B OPD Block,A Block,AIIMS JODHPUR,RAJASTHAN-342001
Jodhpur RAJASTHAN 342001 India |
| Phone |
9974013808 |
| Fax |
|
| Email |
shahkashish88888@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Satyaprakash Meena |
| Designation |
Additional Professor |
| Affiliation |
Aiims Jodhpur |
| Address |
525,5B OPD Block,A Block,AIIMS JODHPUR,RAJASTHAN-342001
Jodhpur RAJASTHAN 342001 India |
| Phone |
8010861072 |
| Fax |
|
| Email |
drsatyaprakash04@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Satyaprakash Meena |
| Designation |
Additional Professor |
| Affiliation |
Aiims Jodhpur |
| Address |
525,5B OPD Block,A Block, AIIMS JODHPUR,RAJASTHAN-342001.
Jodhpur RAJASTHAN 342001 India |
| Phone |
8010861072 |
| Fax |
|
| Email |
drsatyaprakash04@gmail.com |
|
|
Source of Monetary or Material Support
|
| 525,5B OPD Block,A Block,AIIMS JODHPUR,RAJASTHAN,INDIA-342001 |
|
|
Primary Sponsor
|
| Name |
Dr Shah Kashish Bhanu |
| Address |
525,5B OPD Block,A Block,AIIMS JODHPUR,RAJASTHAN-342001 |
| 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 Kashish Shah |
AIIMS JODHPUR |
525,5B OPD Block,A Block,AIIMS JODHPUR,RAJASTHAN,INDIA-342001 Jodhpur RAJASTHAN |
9974013808
shahkashish88888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aiims Jodhpur |
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 suture technique |
Patients undergoing Rectus sheath closure with Continuous suture technique using monofilament Polydioxanone 1-0 suture material
|
| Intervention |
Figure of eight suture technique |
Patients undergoing Rectus sheath closure with Figure of eight interrupted suture technique using monofilament Polydioxanone 1-0 suture materialight suture |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All the consenting patients more than 18 year age undergoing abdominal
closure in an emergency midline laparotomy |
|
| ExclusionCriteria |
| Details |
1.Age more than 80 years
2.Patient undergoing re-laparotomy within 6 months
3.Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine rectus sheath dehiscence in 30 days postoperative period.
|
30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To measure Operative time for fascial closure in minutes.
2) To measure wound infection (Southampton wound grading system)
3)To measure the VAS score at 12 hour, 24 hour & 72 hour after surgery in the same hospital stay |
at 12 hour, 24 hour & 72 hour after surgery in the same hospital stay
|
|
|
Target Sample Size
|
Total Sample Size="128" Sample Size from India="128"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/12/2024 |
| 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 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
|
In emergency surgery, midline exploratory laparotomy is crucial in diagnosing and treating a wide range of life-threatening abdominal conditions [1] Abdominal fascial dehiscence remains a formidable challenge in surgical practice, particularly in emergency laparotomies, where the urgency of intervention often complicates procedural considerations.. Following emergency midline laparotomy, patients are at risk of experiencing a spectrum of complications, both early and late in their postoperative course.Early complications of emergency midline laparotomy may includes burst abdomen and partial dehiscence, while late complications could involve incisional hernia.[2] The risk of fascial dehiscence is notably higher in emergency midline laparotomy compared to elective procedures. This elevated risk stems from the challenges inherent in emergency situations, where preoperative assessment may not be conducted as thoroughly, and the procedure is often performed with multiple risk factors. Malnutrition emerges as a significant risk factor in such scenarios, contributing to increased rates of fascial dehiscence. Consequently, postoperative management necessitates the administration of adequate protein supplementation to decrease this risk and promote optimal healing outcomes.[3] Wound dehiscence rate was found to be 12.4% in emergency midline laparotomy [4]
|