Comparison of two different mesh outcomes in laparoscopic inguinal hernia surgery

Recruiting

Conditions: Unilateral inguinal hernia, without obstruction or gangrene,

Registration Number: CTRI/2023/06/054523

Lead Sponsor: Kodidala Sri Charitha

Brief Summary: lHernioplasty by prosthetic mesh has become gold standard for repair of Inguinal hernia. Mesh repair has become so important in hernia surgery that some understanding of mesh technology is essential for the modern surgeon. The composition and structure of prosthetic meshes varies widely, which influence in the healing process following meshplasty. The use of synthetic mesh substantially reduce the risk of hernia recurrence.

However, polypropylene meshes have been found to cause chronic inflammatory reactions that persist for years and can have potentially negative effects. These effects include chronic pain and feeling of a foreign body in the groin area, which can influence the patientâ€™s quality of life. It was recorded that the incidence of chronic pain after mesh inguinal hernia happens in about 11 % of patients, and still, 3 % report severe pain 1 year after hernia repair. It has been surmised that the extent of the foreign body reaction with its provoked scar tissue is correlated with the amount of the synthetic material used. This led to the development of so-called lightweight mesh characterized by a reduction in the polypropylene volume, an increase in the pore size, or different web structure.

The light weight mesh (LWM) has larger pore size (3-5mm), low weight per unit area(<50gm/m2), stimulates less inflammatory reaction and provides greater elasticity and more flexibility.

The Ultralight weight mesh (ULWM) has larger pore size , lowest weight per unit (<35gm/m2)

The Aim of this study is to compare Light weight mesh vs Ultralight weight mesh repair outcome in Laparoscopic Inguinal Hernia Repair. The objectives are to qualitatively and quantitatively compare the immediate post-operative and chronic inguinal pain. To assess the two types of meshes in terms of their propensity to have post-operative seroma formation, wound infection. To compare chronic inguinal stiffness/Inguinodynia. To evaluate for incidence of recurrence on follow up.

Inclusion criteria: All adult patients (>18 years) with unilateral /Bilateral groin hernia who underwent elective laparoscopic inguinal hernia repair

Exclusion Criteria: 1. Recurrent inguinal hernia 2. Patients with history of previous surgery in the inguino-scrotal region 3. Patients who underwent any other surgery concurrent with laparoscopic inguinal hernia repair.

Patient will be approached for participating in the study and will be explained the details of this study. Once the patient agrees, informed consent will be taken. The case will then be recruited into the study in either Light weight mesh or Ultralight weight mesh group depending on intra-op decisions made by the treating surgeon. There will be no pre study randomization. We will assess the factors like intra operative complications, post-operative pain on immediate post-operative days(POD) as follows- POD1, POD2. We will also assess postoperative complications, days of hospital stay after surgery and patients will be followed up at the end of 1, 3 and 6 months via telephonic conversation postoperatively for any chronic pain, recurrence.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 62

Inclusion Criteria

All adult patients with unilateral /Bilateral groin hernia who underwent elective laparoscopic inguinal hernia repair.

Exclusion Criteria

Recurrent inguinal hernia 2.
Patients with history of previous surgery in the inguino-scrotal region 3.
Patients who underwent any other surgery concurrent with laparoscopic inguinal hernia repair.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare outcomes of light weight mesh vs ultralight weight mesh in laparoscopic inguinal hernia repair in terms of Postoperative pain (Postoperative day 0,1,2), Chronic groin pain, Seroma formation	Day 0, Day 1, Day 2

Secondary Outcome Measures

Name	Time	Method
To compare outcomes of light weight mesh vs ultralight weight mesh in laparoscopic inguinal hernia repair in terms of Hospital stay, Other intraoperative & postoperative complications, Mesh infection, Time to return to routine activities, Recurrence	1 month, 3 months, 6 months

Trial Locations

Locations (1): Kasturba Medical College and Hospital
🇮🇳
Udupi, KARNATAKA, India
Kasturba Medical College and Hospital
🇮🇳Udupi, KARNATAKA, India
Dr Kodidala Sri Charitha
Principal investigator
7760750058
kodidala.kmcmpl2022@learner.manipal.edu