Clinical trial NCT03512366: Comparison Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia
Official title: Comparative Study Between Desarda and Lichtenstein's Technique for Inguinal Hernia Repair Under Local Anaesthesia: A Double Blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernias Inguinal Reducible
Local Anaesthesia
Keywords: inguinal hernia
lichtenstein's technique
desarda's technique
local anaesthesia
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 55
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 7 days
Secondary outcomes:
measure: Time required to return to work
timeFrame: 30 days
measure: Early recurrence within 6 months
timeFrame: 6 months
measure: Post operative pain
timeFrame: 6 month
measure: Presence of wound infection
timeFrame: 6 months
measure: Presence of seroma
timeFrame: 30 days
measure: Presence of haematoma
timeFrame: 30 days
measure: Loss or change in sensation in the operated groin
timeFrame: 30 days
measure: Foreign body sensation
timeFrame: 6 months
measure: Abdominal wall stiffness
timeFrame: 6 months
measure: Testicular edema/atrophy
timeFrame: 6 months
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences
state: Odisha
Study officials:
affiliation: Associate Professor, Dept. of General Surgery
name: Dr. Prakash Ku Sasmal, MBBS,MS,FNB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.