| 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
|
|
|
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
|
|
|
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 |
|
|
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 Desarda’s 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 studies, and 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.
|