Comparison Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-09

Study Completion Date

2020-11-30

Brief Summary

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Inguinal hernia repair is done by two methods. The conventional method uses a prosthetic mesh for strengthening the defect but has been associated with complications. Another new method uses a strip of the external oblique aponeurosis to do the same.There is a necessity to conduct studies comparing the two methods of hernia repair under local anaesthesia in terms of feasibility, economic benefits, faster ambulation with less complications. The purpose of the study is to find a method that will lead to faster disposal of patients and early return to activities, thereby reducing the waiting list of patients that compromises their financial and social spheres and overwhelms the welfare system.

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Detailed Description

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Inguinal hernia is one of the most common treatable surgical conditions. The synthetic prostheses most often used in the inguinal area may in some cases create new clinical problems, such as foreign body sensation in the groin, discomfort, and abdominal wall stiffness, surgical site infections, migration of mesh and may affect procreation and sexual function, The cost and availability of mesh prostheses in smaller towns and underdeveloped regions proves to be a major hindrance. The requirement of the hour is to find a technique that is simple, cost effective, easy to perform, does not require extensive dissection or use of a foreign body, and also gives an acceptable recurrence rate without any major intra or post-operative complications and can be performed as a day care procedure to reduce the burden of cases in our community. A possible option for this is the Desarda method, presented in 2001, which uses an undetached strip of aponeurosis of the external oblique muscle instead of a mesh and has shown to have promising results in studies conducted so far. Several retrospective and randomized controlled trials have shown that local anaesthesia provides the best clinical and economic benefits to patients undergoing inguinal hernia repair. As there have been no studies till date comparing the outcomes for patients operated by these methods under local anaesthesia only, hence this study has been planned to assess if Desarda's technique is suitable to be used as a day care procedure with early return to normal activities after surgery, less post operative discomfort and minimum dose of analgesics and acceptable recurrence rates. This will help reduce the burden of the hospitals as these patients can be operated on a day care basis with minimal discomfort.

Conditions

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Hernias Inguinal Reducible Local Anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

DESARDA'S NO MESH REPAIR:

It will be performed according to the surgical technique described by Dr. Desarda. A strip will be separated from the upper leaf of the external oblique aponeurosis keeping its insertion and continuity with the muscle intact. This strip will be sutured with the inguinal ligament below and the newly formed upper leaf of EOA above behind the spermatic cord to form the new inguinal floor. Continuous non absorbable prolene 2-0 suture will be used to secure the aponeurotic strip to the inguinal ligament inferiorly , and the strip will be secured superiorly to the internal oblique muscle using interrupted absorbable vicryl sutures. This strip will be put under tension by muscular contraction and works as a shield to prevent recurrence as it gives additional strength to the weakened internal oblique and transverses abdominis muscles.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

This will be a double blind trial .The patient will not be revealed about the technique being performed. The investigator who will follow up the patients post operatively in the out-patient clinic will also be blinded about the procedure performed on the patient.

Study Groups

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Desarsda's technique

These patients wil be operated by the Desarda's technique without using any prosthetic mesh. A strip of external oblique aponeurosis will be used to strengthen the defect.

Both field block and local infiltration with tumescent anaesthesia techniques will be used for anaesthesia

Intervention:

A strip will be separated from the upper leaf of the external oblique aponeurosis keeping its insertion and continuity with the muscle intact. This strip will be sutured with the inguinal ligament below and the muscle arch or conjoint tendon above behind the spermatic cord to form the new inguinal floor. Continuous non absorbable prolene 2-0 suture will be used to secure it to the inguinal ligament inferiorly , and will be secured superiorly to the internal oblique muscle using interrupted absorbable vicryl sutures.

Group Type EXPERIMENTAL

Desarda's technique

Intervention Type PROCEDURE

It will be performed by separating a strip from the upper leaf of the external oblique aponeurosis in continuity with the muscle and suturing it with the inguinal ligament below and the newly formed upper leaf of EOA above behind the spermatic cord to form the new inguinal floor. This strip will be put under tension by muscular contraction and works as a shield to prevent recurrence.

Lichtenstein's technique

These patients will be operated using prosthetic mesh described as Lichtenstein's tension free mesh hernioplasty.

Both field block and local infiltration with tumescent anaesthesia techniques will be used for anaesthesia.

Intervention :

A 6 × 11 cm polypropylene mesh will be fashioned to fit the posterior wall of the inguinal canal and sutured to the fibro-periosteum of the pubic bone and continued laterally, suturing the inferior edge of the mesh to the shelving edge of the inguinal ligament to a point 2 cm lateral to the internal ring. Laterally, 2 cm silt will be made through the mesh to accommodate the cord. while the two tails will be sutured to create a new deep ring made of mesh.

Group Type ACTIVE_COMPARATOR

Lichtenstein's technique

Intervention Type PROCEDURE

A 6 × 11 cm polypropylene mesh will be fashioned to fit the posterior wall of the inguinal canal and sutured to the fibro-periosteum of the pubic bone and continued laterally, suturing the inferior edge of the mesh to the shelving edge of the inguinal ligament to a point 2 cm lateral to the internal ring.

Interventions

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Desarda's technique

It will be performed by separating a strip from the upper leaf of the external oblique aponeurosis in continuity with the muscle and suturing it with the inguinal ligament below and the newly formed upper leaf of EOA above behind the spermatic cord to form the new inguinal floor. This strip will be put under tension by muscular contraction and works as a shield to prevent recurrence.

Intervention Type PROCEDURE

Lichtenstein's technique

A 6 × 11 cm polypropylene mesh will be fashioned to fit the posterior wall of the inguinal canal and sutured to the fibro-periosteum of the pubic bone and continued laterally, suturing the inferior edge of the mesh to the shelving edge of the inguinal ligament to a point 2 cm lateral to the internal ring.

Intervention Type PROCEDURE

Other Intervention Names

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Desarda's No mesh repair Lichtenstein's tension free mesh hernioplasty

Eligibility Criteria

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Inclusion Criteria

* Primary uncomplicated inguinal hernia
* Male patients aged more than 18 years and less than 80 years
* BMI less than 30kg/sq m
* American Society of Anaesthesiologists (ASA) scale less than III

Exclusion Criteria

* Patients with recurrent, irreducible or strangulated inguinal hernias
* Patients unable to interpret VAS or give consent
* Patients participating in other clinical trials
* Patients with infection in the inguinal region or epididymo-orchitis
* Patients allergic to local anaesthetics

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes