Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair

Moulana Hospital

Status and phase: Completed; Phase 4

Conditions: Inguinal Hernia

Treatments: Procedure: Mesh Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT01117337

MH-ECN-04-08

Details and patient eligibility

About

The purpose of the study is

1. To compare the recurrence rate of the laparoscopic total extra peritoneal inguinal hernia repair without fixation of the mesh to mesh fixation under spinal anesthesia
2. To test whether non-fixation of mesh leads to less pain compared to the repair when the mesh is fixed.

Full description

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 India 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 repair. 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 earlier reported that TEP repair could be done without fixation of the mesh under regional anesthesia.

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 of the hernia and pain in the post operative period.

Enrollment: 104 patients

Sex: All

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All reducible inguinal hernias will be included in the study

Exclusion criteria

• Irreducible hernia after anesthesia
• Obstructed and strangulated hernias
• Pediatric hernias
• Associated other hernias like ventral hernias
• Unfit for spinal anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 1 patient group

Mesh Non Fixation Group

No Intervention group

Description:

Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed by ant means

Treatment:

Procedure: Mesh Fixation