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CTRI Number  CTRI/2024/05/068146 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 27/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of two techniques for primary inguinal hernia repair( Lichenstein versus Desarda technique) in adolescents and young adults. 
Scientific Title of Study   A Randomised Control Trial to compare Lichenstein versus Desarda technique for primary inguinal hernia repair in adolescents and young adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IM012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohit Kapoor 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Room No. 608, Sixth Floor, Hospital Building
All India Institute of Medical Sciences, Dalmau Road, munshiganj, Raebareli
Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9453193753  
Fax    
Email  rohit.kapoor13081988@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rohit Kapoor 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Room No. 608, Sixth Floor, Hospital Building
All India Institute of Medical Sciences, Dalmau Road, munshiganj, Raebareli

UTTAR PRADESH
229405
India 
Phone  9453193753  
Fax    
Email  rohit.kapoor13081988@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rohit Kapoor 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Room No. 608, Sixth Floor, Hospital Building
All India Institute of Medical Sciences, Dalmau Road, munshiganj, Raebareli

UTTAR PRADESH
229405
India 
Phone  9453193753  
Fax    
Email  rohit.kapoor13081988@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raebareli, Dalmau Road, Munshiganj, Raebareli, U.P. India-229405 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Raebareli 
Address  All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Raebareli, U.P, India- 229405 
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 Rohit Kapoor  All India Institute of Medical Sciences, Raebareli  All India Institute of Medical Sciences, Raebareli, Almau road, Munshiganj, Raebareli, U.P. India-229405
Rae Bareli
UTTAR PRADESH 
9453193753

rohit.kapoor13081988@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BIOETHICS CELL, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAEBARELI  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 
Intervention  Desarda procedure  Desarda mesh free tissue repair that was described by Dr Mohan P Desarda in 2001. Involves use of External oblique Aponeurosis to strengthen posterior wall of inguinal canal without use of mesh 
Comparator Agent  Licheinstein repair  Involves use of Prolene mesh to strengthen posterior wall/ floor of the inguinal canal.  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  All adolescents and young adults aged between 13 years to 25 years diagnosed as case of inguinal hernia in department of paediatric surgery and department of general surgery and fit for regional/general anaesthesia. 
 
ExclusionCriteria 
Details  Patients below 13 years and above 25 years of age.
Patients with an aponeurosis that was divided, tiny, and/or weak.
Patients with recurrent or strangulated hernias.
American Society of Anesthesiologists(ASA) scale at more than 3  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Hernia recurrence in one year of follow-up.
Occurrence of any chronic pain- defined as moderate (VAS 30 to 54) or strong (VASgreater than 54) pain lasting more than 6 months after surgery.
 
1 year.
6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
General and local complications(graded as per clavein dindo classification)  1 year 
ï‚§ Length of time to return to various levels of everyday activity{Return to normal activity will be defined as the patient’s ability to perform elementary activities [i.e., dressing, walking, bathing (basic activity)]; usual activities at home [i.e., preparing food, cleaning house (home activity)]; and returning to all previously performed activities (work activity)}  1 year 
ï‚§ Presence or absence of foreign body sensation, and abdominal wall stiffness in the groin area.  1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   15/06/2024 
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 Yet Recruiting 
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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 (Others) -  A cloud link will be shared as soon as final data is compiled for analysis

  6. For how long will this data be available start date provided 27-05-2026 and end date provided 27-05-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Inguinal hernia is generally defined as protrusion of the contents of the abdominal cavity or preperitoneal fat through a defect in the inguinal area. Although incidence and prevalence reported in literature vary and is not precisely known, the lifetime chance of a person being operated for inguinal hernia is quiet high, 27% in men and 3% in women. As per European hernia society(EHS) guidelines published in 2009 for management of adult hernias state that Lichenstein technique or endoscopic methods should be used for repair of inguinal hernias in adults. This is in contrast to practice in paediatric population where high ligation of hernia sac is recommended. However, adolescent patients represent a “gray zone” between children and adults, and there is no consensus on the most appropriate surgery for inguinal hernias in these patients. Type of operation in these patients largely depends on the surgeon. Adult surgeons prefer to repair adolescent hernias with a mesh repair and pediatric surgeons tend to repair them with a high ligation of the sac. Although, mesh has been shown to be quite beneficial in terms of decreasing recurrence rates in inguinal hernias in adults, there are potential morbidities related to mesh use, such as chronic pain, seromas, infections, and infertility. Because of this, the avoidance of mesh may be preferable in inguinal hernia repairs in adolescents and young adults, if not at the sacrifice of increased hernia recurrence. Due to this, various mesh free tissue repair techniques have been described in literature. The most popular is the Shouldice repair technique, which is considered best among the non-mesh repair techniques with strength of recommendation level 1A. However, although the Shouldice method has recurrence rates of less than 1%, its technically demanding nature can potentially increase the incidence of recurrence of up to 15% with the less experienced and less trained hands. Therefore, other mesh free tissue repair techniques have been described throughout the literature one of which is Desarda mesh free tissue repair that was described by Dr Mohan P Desarda in 2001. The technique requires no complicated dissection or suturing, and is easy to learn as its developer claimed. Moreover, It does not require any foreign material and does not use weakened muscles or transversalis fascia for repair. Some authors have therefore concluded that the Desarda repair has the potential to become the new gold standard particularly in low-income and middle-income countries. Also, as results of Desarda technique appears promising in various studies in literature, a randomised control trial can be planned to compare this comparatively newer technique with the standard Lichtenstein technique of inguinal hernia repair, especially in adolescent and young adult population.

 
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