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CTRI Number  CTRI/2025/12/099416 [Registered on: 18/12/2025] Trial Registered Prospectively
Last Modified On: 18/12/2025
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   Randomized trial comparing short-term outcomes of Desarda vs. Lichtenstein hernia repair 
Scientific Title of Study   Comparison of Short-term outcomes between Desardas tissue repair and Lichtensteins meshplasty in Inguinal hernia surgery: A Double blinded Randomized control trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kommu Siddhartha Raj 
Designation  Junior resident  
Affiliation  JIPMER, Pondicherry 
Address  Dept. of general surgery, 2nd floor, Old IPD building, JIPMER, Pondicherry Pin-605006
Dept. of general surgery, 2nd floor, Old IPD building, JIPMER, Pondicherry Pin-605006
Pondicherry
PONDICHERRY
605006
India 
Phone  9381577534  
Fax    
Email  siddhartharaj2k@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Uday Shamrao Kumbhar 
Designation  Professor 
Affiliation  JIPMER, Pondicherry 
Address  Dept. of general surgery, 2nd floor, Old IPD building, JIPMER, Pondicherry Pin-605006
Dept. of general surgery, 2nd floor, Old IPD building, JIPMER, Pondicherry Pin-605006
Pondicherry
PONDICHERRY
605006
India 
Phone  9940306513  
Fax    
Email  k26uday74@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Kommu Siddhartha Raj 
Designation  Junior resident  
Affiliation  JIPMER, Pondicherry 
Address  Dept. of general surgery, 2nd floor, Old IPD building, JIPMER, Pondicherry Pin-605006
Dept. of general surgery, 2nd floor, Old IPD building, JIPMER, Pondicherry Pin-605006
Pondicherry
PONDICHERRY
605006
India 
Phone  9381577534  
Fax    
Email  siddhartharaj2k@gmail.com  
 
Source of Monetary or Material Support  
Dean research office, 1st floor, JISPH building,JIPMER campus road, Dhanavantari nagar, Gorimedu, Puducherry Pin: 605006 
 
Primary Sponsor  
Name  JIPMER (IMRF) 
Address  JIPMER campus, JIPMER road, Gorimedu, Dhanavantari nagar, Puducherry Pin- 605006 
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 Siddhartha Raj  JIPMER, Pondicherry  Dept. of general surgery, 2nd floor, Old IPD building, JIPMER, Pondicherry Pin-605006
Pondicherry
PONDICHERRY 
9381577534

siddhartharaj2k@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee-Interventional studies, JIPMER, Pondicherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DESARDAS TISSUE REPAIR FOR INGUINAL HERNIA  Desarda operation is tension-free, mesh-free inguinal hernia repair. It involves reinforcing the posterior wall of the inguinal canal with a strip of the patients own external oblique aponeurosis, rather than by the use of a synthetic mesh. Below are the overall steps of the Desarda surgical procedure: Incision: A routine oblique incision is performed in the groin to approach the external oblique aponeurosis. Dissection: The spermatic cord is dissected free and the hernia sac is located. Gently, herniated organs are returned to the abdomen. The hernia sac is usually dissected free and removed. Formation of the Aponeurotic Strip: A strip of tissue is formed from the external oblique aponeurosis. The strip is not completely detached; its medial and lateral attachments are left intact. The strip is usually 1-2 cm in width. Suturing the Strip: The bottom edge of the newly formed aponeurotic strip is sutured to the inguinal ligament. The top, free edge of the strip is now sutured to the internal oblique muscle or conjoined muscle. Closing the Canal: The upper remaining flap of the external oblique aponeurosis is sutured over the spermatic cord and the new strip, thus forming a two-layered, strengthened posterior wall for the inguinal canal. Closure: The wound is closed in layers with sutures. The method is intended to be a "physiological" repair, since the aponeurotic strip is a living tissue that remains within the active system of abdominal muscles. When the abdominal muscles contract, the strip tightens, giving a protective and compressive force to the inguinal canal, which protects against a recurrence of hernia. 
Comparator Agent  Lichtensteins meshplasty  These are the common steps of the Lichtenstein procedure: Incision: A routine oblique incision is performed in the groin, parallel to the inguinal ligament. Dissection: The external oblique aponeurosis and the spermatic cord (round ligament in the female) are exposed as the surgeon dissects through the layers of the abdominal wall. Hernia Sac Management: The hernia sac is dissected out and mobilized from the spermatic cord. The sac contents are displaced back into the abdominal cavity. The sac itself can be ligated and removed, or reduced back into the abdomen. Mesh Preparation: Synthetic mesh, usually polypropylene, is cut to a particular size and form. A slit is made in the mesh to fit over the spermatic cord, which forms two "tails" or "limbs." Mesh Positioning: The mesh is positioned over the posterior wall of the inguinal canal and covers the whole floor of the canal and extends beyond a point more superficial than the deep inguinal ring. The "tails" of the mesh are passed around the spermatic cord. Mesh Fixation: The mesh is secured by a non-absorbable suture. The medial aspect of the mesh is fixed to the strong pubic tubercle. The lower border of the mesh is tied to the inguinal ligament. The top border of the mesh is tied to the internal oblique aponeurosis. The "tails" of the mesh are passed over one another around the spermatic cord and tied together to form a new, supported internal inguinal ring. Closure: The external oblique aponeurosis and the layers of the abdominal wall are closed by the surgeon over the spermatic cord and the mesh. The subcutaneous tissue and skin are closed in sutures. The "tension-free" feature of this repair is a major advantage. By employing a mesh as a bridge to close the defect, the surgeon is able to avoid bringing the patients natural tissues together under tension. This decreases post-operative discomfort and dramatically reduces the risk of hernia recurrence compared with older tension-based repair methods. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All consenting patients above 18 years of age with primary unilateral uncomplicated inguinal hernia planned for elective open inguinal hernia repair 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine and compare the incidence of Chronic groin pain (at 3months) measured by visual analogue scale (VAS) following Lichtenstein’s tension free meshplasty and Desarda’s tissue repair in patients undergoing unilateral primary inguinal hernia repair  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Operating time  
Early Post operative pain  Day 0, Day 1, 1 week 
Duration of hospital stay post operatively  In days 
Incidence of Early post operative complications (Hematoma formation)  Day 1, 1 week 
Incidence of Early post operative complications (Seroma formation)  Day 8, 1 month, 3 months 
Early hernia recurrence  3 months 
Quality of life (using SF36 & EuraHS-QoL scale)  3 months 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   29/12/2025 
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="1"
Months="9"
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  

Hernia has been continuing as one of the oldest and one of the most common common surgical pathology. The surgical intervention for hernia has taken leaps over the past few years. Starting with simple open procedures as Shouldice and bassini repair to, it has evolved over time to such complex laparoscopic and robotic surgeries[11]

 

The comparison and contrast between Desardas tissue repair and Lichtenstein meshplasty for the repair of inguinal hernia has increasingly been discussed in medical literature to assess their effectiveness in both short-term and long-term outcomes. Desarda’s repair, described in the early 21st century, is a tension-free method that precludes the use of synthetic mesh by employing the external oblique aponeurosis to provide support to the abdominal wall. This technique has been recognized for its simplicity and the use of no foreign materials, thereby minimizing risks of complications such as chronic pain, infection, and rejection. Its shorter recovery time and lower incidences of post-operative pain have been noted in studiesand it is considered a promising alternative, especially in resource-limited environments.

The Lichtenstein meshplasty
, on the other hand, is still the gold standard in hernia repair because of its established capacity to reduce recurrence rates. This method uses a polypropylene mesh to provide reinforcement to the compromised abdominal wall through a tension-free repair.[12] 

 

Though effective, it has been known to have complications like chronic pain related to the mesh, foreign body sensation, and, rarely, mesh migration. Randomized controlled trials and meta-analyses have yielded inconsistent findings when the two methods are compared, with some reporting similar success rates and others supporting one method over the other based on particular patient groups or surgical settings.

 
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