FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
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 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  
Status 
Not Applicable 
 
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]


 
Close