Comparing non-fixation of mesh to mesh fixation in laparoscopic inguinal hernia repair

• Conditions: Inguinal Hernia

• Registration Number: CTRI/2009/091/000020
• Lead Sponsor: Self

Brief Summary

Hernia repair is one of the most common surgery performed all over the world. The same is true about India. With more than a billion population, the number of hernia patients in our country perhaps run in millions. The laparoscopic repair is increasingly becoming popular in India. Decreased post operative pain and lesser morbidity are the main advantages of Total Extra Peritoneal Repair (TEP) over open hernia repair. Laparoscopic hernia repair is now recommended as the method of choice for bilateral and recurrent inguinal hernias. The disadvantages of TEP are requirement of general anesthesia (GA), need to fix the mesh, seroma formation and difficult learning curve. Fixation of mesh with metal staples, apart from increasing the cost, may lead to new post operative groin pain which even becomes chronic in small percentage of patients. This had led to various studies showing that the non-fixation of mesh is safe, cost effective and lead to no increased risk of hernia recurrence compared to the conventional open hernia repair10-16. Requirement of GA for TEP repair also had several disadvantages compared to regional anesthesia such as significant hemodynamic changes, delayed recovery, post operative nausea and vomiting, increased cost and inability to give anesthesia in high cardio-pulmonary risk patients. Several studies in recent past have demonstrated TEP is feasible and safe in regional anesthesia (epidural or spinal) as well. We reported that TEP repair could be done without fixation of the mesh under regional anesthesia. A retrospective analysis of recurrence rates, post operative pain outcomes and other morbidity factors was done in 1289 hernia repairs in 675 patients. Laparoscopic TEP hernia repair done under spinal anesthesia with non fixation of the mesh was compared to repairs done under general anesthesia with non fixation of the mesh and repairs done under spinal anesthesia (SA) with fixation of mesh. The results showed that TEP, done under SA and without fixation of the mesh, was safe, feasible and associated with recurrence rate, which was low and similar to TEP hernia repair done with fixation of the mesh or under general anesthesia. Since this procedure (TEP done under regional anesthesia without fixation of the mesh) didn?t have the disadvantages usually attributed to TEP (need for GA and fixation of mesh), it could perhaps be suggested as a first line procedure even for unilateral inguinal hernias.This study is a Randomized Controlled Trial (RCT) comparing the outcome of non-fixation of mesh during laparoscopic inguinal hernia repair with fixation of mesh under spinal anesthesia. The end points measured would be the recurrence level and pain in the post operative period. The patients undergoing laparoscopic total extra peritoneal (TEP) inguinal hernia repair under spinal anesthesia would be randomized in to either of the two groups- Fixation of mesh and Non-fixation of Mesh. The purpose of the study is?To verify the safety and efficacy of the laparoscopic total extra peritoneal inguinal hernia repair without fixation of the mesh under spinal anesthesia?To test whether non-fixation of mesh leads to less pain compared to the repair when the mesh is fixed.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

All reducible inguinal hernias will be included in the study.

Exclusion Criteria

• Irreducible hernia after anesthesia, obstructed and strangulated hernias, pediatric hernias and patients with associated other hernias like ventral hernias will be excluded from the study.
• Patients unfit for spinal anesthesia will also be excluded from the study.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence rate	6 months

Secondary Outcome Measures

Name	Time	Method
Pain	Post operative-6 hours, 24 hours, 1 week
Days to resume work	1 week

Trial Locations

Locations (1)

Moulana Hospital; 🇮🇳 India

Moulana Hospital

🇮🇳India

Dr Mohamed Ismail

Principal investigator

09447128511

mdismail13@gmail.com