- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06712212
Non-mesh Repair of Inguinal Hernia: Desarda Versus Darn
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inguinal hernia is one of the most common types of abdominal hernias with a prevalence of 75% of all abdominal hernias. Inguinal hernia repair is one of the most encountered surgeries all over the world. The use of mesh for inguinal hernia repair is the most commonly applied technique. However, being a foreign body, mesh repair has its own disadvantages. These include Postoperative hematoma and seroma, foreign body reaction, infection, mesh rejection, mesh migration, and fistula formation. Moreover, the use of mesh in potentially contaminated operating field is not advisable. Infectious complication and their consequences have restricted the use of mesh in emergency settings. In addition, mesh repair is not available in every part of the world since it increases the cost of the operation. Therefore, the non-mesh repair of inguinal hernia has been recently revisited. Different techniques for non-mesh inguinal hernia repair are available including Bassini, Shouldice, Desarda and Darn. In 2001,Indian Surgeon Dr. Desarda, introduced a novel technique of a tissue- based hernia repair without mesh with almost zero recurrence rates in which an undetached strip of the external oblique aponeurosis is sutured to the inguinal ligament below and the muscle arch above, behind the cord, to form a new posterior wall. External oblique muscle gives additional strength to the weakened muscle arch to keep this strip physiologically dynamic. In 1948, Moloney described a suture inguinal herniorrhaphy in which two layers of continuous monofilament non-absorbable suture lines with no tension were inserted. The first suture line is between the lower edge of the internal oblique muscle/aponeurosis and the inguinal ligament. The second superficial layer is between the rectus sheath and the inguinal ligament. All sutures should be placed without tension but with no slack .
Literature are deficient in comparing Desarda technique and Darn technique in the repair of inguinal hernia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Assiut, Egypt, 71151
- Assiut University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- inguinal hernia
- Age more than 18
- Male patients
Exclusion Criteria:
• simultaneous performance of other surgical procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Inguinal hernia
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A splitting incision is made in this sutured medial leaf, partially separating a strip 1.5-2 cm wide.
This splitting incision is extended medially up to the pubic symphysis and 1-2 cm beyond the abdominal ring laterally.
The medial insertion and lateral continuation of this strip is kept intact.
The upper free border of the strip is now sutured to the internal oblique with number 1 Monofilament Polydioxanone Violet continuous sutures all along its length.
This will result in the strip of the EOA being placed behind the cord to form a new posterior wall of the inguinal canal.
The spermatic cord is placed in the inguinal canal and the lateral leaf of the EOA is sutured to the newly formed medial leaf of the EOA in front of the cord.
As before, number 1 Monofilament Polydioxanone Violet continuous sutures were used.
Undermining of the newly formed medial leaf on both its surfaces and excision of the bulky cremasteric muscle facilitate its approximation to the lateral leaf
Other Names:
Skin and fascia are incised using a regular, oblique inguinal incision to expose the external oblique aponeurosis (EOA) the inguinal canal is opened into by dividing the external oblique aponeurosis through the external ring.
After dealing with the hernia sac, a 0-size monofilament suture was used to reconstruct the inguinal bed with a tension-free darn starting with a good strong bite of the tough tendinous structures near the pubic tubercle and emerging out through the lateral edge of the internal oblique/rectus sheath from one side and through the inguinal ligament on the other side.
The loosely interwoven bites continued laterally and the back-forming two rows of continuous stitches were placed in a staggered manner to spread the tension between the fibres of the inguinal ligament.
Afterwards, the external oblique and other superficial layers with the skin are classically closed
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Short term recurrence of hernia
Time Frame: From the day post operative to 6 months after the operation
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From the day post operative to 6 months after the operation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Inguinal hernia repair
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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