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

NCT03512366 | Unknown

• 1 other identifier: IECAIIMSBBSRPGThesis/17-18/38
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hernias Inguinal Reducible; Local Anaesthesia

Keywords

inguinal hernia; lichtenstein's technique; desarda's technique; local anaesthesia

Outcome Measures

Primary Outcomes (1)

• To compare Desarda and Lichtenstien's inguinal hernia repair techniques under local anaesthesia, in terms of time taken to return to normal gait with comfort post surgery.

  Time taken to return to normal gait comfortably after the surgery is calculated based on the ability to walk comfortably or move freely after surgery, as measured by ability to bend, squat, kneel ,stoop.

  7 days

Secondary Outcomes (10)

• Time required to return to work

  30 days

• Early recurrence within 6 months

  6 months

• Post operative pain

  6 month

• Presence of wound infection

  6 months

• Presence of seroma

  30 days

Study Arms (2)

Desarsda's technique

EXPERIMENTAL

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.

Procedure: Desarda's technique

Lichtenstein's technique

ACTIVE COMPARATOR

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.

Procedure: Lichtenstein's technique

Interventions

Desarda's technique 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.

Also known as: Desarda's No mesh repair

Desarsda's technique

Lichtenstein's technique 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.

Also known as: Lichtenstein's tension free mesh hernioplasty

Lichtenstein's technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Male patients are only included in the trial
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences

Bhubaneswar, Odisha, 751019, India

RECRUITING

Related Publications (2)

• Szopinski J, Dabrowiecki S, Pierscinski S, Jackowski M, Jaworski M, Szuflet Z. Desarda versus Lichtenstein technique for primary inguinal hernia treatment: 3-year results of a randomized clinical trial. World J Surg. 2012 May;36(5):984-992. doi: 10.1007/s00268-012-1508-1.

  PMID: 22392354 BACKGROUND

• Sasmal PK, Sahoo A, Mishra TS, Das Poddar KK, Ali SM, Singh PK, Kumar P. Feasibility and outcomes of Desarda vs Lichtenstein hernioplasty by local anesthesia for inguinal hernia: a noninferiority randomized clinical trial. Hernia. 2023 Oct;27(5):1155-1163. doi: 10.1007/s10029-023-02837-5. Epub 2023 Jul 15.

  PMID: 37452974 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Prakash Ku Sasmal, MBBS,MS,FNB

  Associate Professor, Dept. of General Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Prakash K. Sasmal, MBBS,MS,FNB

CONTACT

9438884255; drpksasmal@gmail.com

Dr. Ankit Sahoo, MBBS

CONTACT

7504294760; ankitsahoo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR, DEPT. OF GENERAL SURGERY

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 30, 2018
• Study Start: December 9, 2017
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)