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CTRI Number  CTRI/2024/03/064359 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 28/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Abdominal closure after emergency laparotomy  
Scientific Title of Study   Abdominal Closure after Emergency Laparotomy (ACE) trial: Comparison of Mass closure and Small bites techniques for closure after emergency laparotomy 
Trial Acronym  ACE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshant 
Designation  Senior Resident  
Affiliation  Dr Babasaheb Ambedkar Hospital  
Address  Department of general surgery, Dr BSA Hospital, Rohini sector 6

North
DELHI
110085
India 
Phone  9953558813  
Fax    
Email  akshantp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Akshant 
Designation  Senior Resident  
Affiliation  Dr Babasaheb Ambedkar Hospital  
Address  Department of general surgery, Dr BSA Hospital, Rohini sector 6

North
DELHI
110085
India 
Phone  9953558813  
Fax    
Email  akshantp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Akshant 
Designation  Senior Resident  
Affiliation  Dr Babasaheb Ambedkar Hospital  
Address  Department of general surgery, Dr BSA Hospital, Rohini sector 6


DELHI
110085
India 
Phone  9953558813  
Fax    
Email  akshantp@gmail.com  
 
Source of Monetary or Material Support  
Dr Babasaheb Ambedkar Hospital and Medical College  
 
Primary Sponsor  
Name  Dr Babasaheb Ambedkar Hospital  
Address  SECTOR 6 ROAD, NEAR ROHINI WEST METRO STATION, ROHINI 
Type of Sponsor  Government medical college 
 
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 Akshant  Department of General Surgery   Emergency Surgical Ward, Department of Surgery
North
DELHI 		 9953558813

akshantp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committeee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K650||Generalized (acute) peritonitis, (2) ICD-10 Condition: K913||Postprocedural intestinal obstruction, (3) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (4) ICD-10 Condition: K566||Other and unspecified intestinal obstruction, (5) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mass closure of abdominal wall  At the time of rectus sheath closure after laparotomy, all the layers of the abdominal wall, namely, anterior rectus sheath, rectus muscle and posterior sheath are incorporated in the bite taken. The stitch is placed in a continuous pattern with 1 cm by 1 cm distance between the bites. The closure is done with 2-0 PDS suture.  
Intervention  Small bites closure of abdominal wall   At time of rectus sheath closure after laparotomy, bites are taken from the rectus sheath anterior and posterior layers, excluding the rectus muscle, in a pattern of 0.5 cm by 0.5 cm without incorporating the muscle layers in a continuous fashion. Closure is to be done with 2-0 PDS.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients undergoing emergency laparotomy with a midline abdominal incision  
 
ExclusionCriteria 
Details  1. Pregnant women
2. Patients with non midline incision used to open the abdomen
3. Patients undergoing damage control laparotomy  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of Incisional Hernia postoperatively   3 months, 6 months, 12 months, 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Burst abdomen  3 days, 7 days, 14 days, 28 days post operatively 
 
Target Sample Size   Total Sample Size="296"
Sample Size from India="296" 
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)   01/04/2024 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [akshantp@gmail.com].

  6. For how long will this data be available start date provided 01-05-2026 and end date provided 30-04-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Randomised, double blinded trial comparing small bites closure to mass closure with regards to their effect on rates of incisional hernia after emergency laparotomy. Mass closure is the current standard of care, however, small bites closure has been shown to reduce incidence of incisional hernia in elective surgery. Calculated sample size is 148 patients per arm. Primary outcome measure is incidence of incisional hernia post procedure. Secondary outcome measure is incidence of burst abdomen post procedure. Total duration of followup is 2 years from index procedure.  
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