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CTRI Number  CTRI/2024/04/065139 [Registered on: 03/04/2024] Trial Registered Prospectively
Last Modified On: 31/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Application of abdominal binder after incisional hernia surgery]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of postoperative abdominal binder on outcomes of open incisional hernia repair 
Scientific Title of Study   Role of postoperative abdominal binder on outcomes of open incisional hernia repair in a tertiary care institute 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashesh Kumar Jha 
Designation  Additional Professor 
Affiliation  AIIMS, Patna 
Address  Room no.-306 Department of General Surgery AIIMS Patna Bihar
Danapur Patna Bihar
Patna
BIHAR
801505
India 
Phone  9582199339  
Fax    
Email  asheshjha04@gmil.com  
 
Details of Contact Person
Scientific Query
 
Name  Ashesh Kumar Jha 
Designation  Additional Professor 
Affiliation  AIIMS, Patna 
Address  Room - 306 Department of General Surgery AIIMS Patna Bihar
Danapur Patna Bihar

BIHAR
801505
India 
Phone  9582199339  
Fax    
Email  asheshjha04@gmil.com  
 
Details of Contact Person
Public Query
 
Name  Ashesh Kumar Jha 
Designation  Additional Professor 
Affiliation  AIIMS, Patna 
Address  Room - 306 Department of General Surgery AIIMS, Patna Bihar
Danapur Patna Bihar

BIHAR
801505
India 
Phone  9582199339  
Fax    
Email  asheshjha04@gmil.com  
 
Source of Monetary or Material Support  
Department of General Surgery AIIMS, Patna, Bihar - 801505 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  Department of General Surgery AIIMS, Patna Phulwarisharif Bihar - 801505 
Type of Sponsor  Research institution and hospital 
 
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 Ashesh Kumar Jha  AIIMS, Patna  Department of General Surgery, AIIMS, Patna
Patna
BIHAR 
09582199341

asheshjha04@gmil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committeee, AII India Institute of Medical Sciences, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K432||Incisional hernia without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  After open incisional hernia repair no abdominal binder will be applied  In this group of participants after incisional hernia repair no abdominal binder will be applied 
Intervention  Application of abdominal binder after open incisional hernia repair  Patients undergoing incisional hernia repair meeting the inclusion criteria and willing to participate in this study and based on group allocation will be offered abdominal binder after open incisional hernia surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Midline incisional hernia with a defect size of up to 10cms
• ASA I and II
• Age group 18 to 65 years
 
 
ExclusionCriteria 
Details  Age less than 18 and more than 65 years old
BMI more than 30
Diabetes, COPD and known immunosuppressive conditions
Loss of domain and recurrent hernia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare post operative seroma formation in both the groups  24 hours drain output as long as drain remains in situ and thereafter at one month by USG abdomen 
 
Secondary Outcome  
Outcome  TimePoints 
- The length of hospital stays in days
- To measure the pain in both group at various time interval by applying VAS
- Patient comfort by Carolina comfort scale and ability to mobilize by functional ambulation categories at different time intervals in patients with and without use of abdominal binder after open incisional hernia repair
 
Hourly and daily based on outcomes 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   22/04/2024 
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="6"
Days="15" 
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  

Incisional hernia repair is a common surgical procedure, which usually accounts for 15 to 18% of all surgeries.  Both minimally invasive or open surgical methods of hernia repair has been described. Understandably, minimally invasive approach causes less pain, lower surgical site occurrences and post-operative discomfort in comparison to the open surgical technique of incisional hernia repair. Moreover, these relatively common post-operative sequalae of open hernia repair can increase the post operative morbidity and prolong the hospital stay of the patients.

 

Apart from prescribing routine postoperative care, some alternative methods are also practiced to minimize the chances of postoperative pain, surgical site occurrences and patient’s discomfort. One such practice is the application of elastic abdominal binders.  It’s beneficial effect after midline laparotomies is being reported by the various studies. Abdominal binders are proposed to reduce stress on wounds, abdominal muscle actions during mobilization and increase vascularity to the incision site and mitigate surgical site edema (seroma)                                                   

There is a paucity of literature highlighting the beneficial effects of elastic abdominal binder after open incisional hernia repair. Therefore, we are conducting this study to evaluate the role of abdominal binder in cases of open incisional hernia repair.

 

 
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