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

2014-08-27 03:13:54 | BioPortfolio

Summary

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Inguinal Hernia

Intervention

Mesh Non Fixation

Location

Moulana Hospital
Perintalmanna
Kerala
India
679322

Status

Active, not recruiting

Source

Moulana Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:54-0400

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Medical and Biotech [MESH] Definitions

An abdominal hernia with an external bulge in the GROIN region. It can be classified by the location of herniation. Indirect inguinal hernias occur through the internal inguinal ring. Direct inguinal hernias occur through defects in the ABDOMINAL WALL (transversalis fascia) in Hesselbach's triangle. The former type is commonly seen in children and young adults; the latter in adults.

A protrusion of abdominal structures through the retaining ABDOMINAL WALL. It involves two parts: an opening in the abdominal wall, and a hernia sac consisting of PERITONEUM and abdominal contents. Abdominal hernias include groin hernia (HERNIA, FEMORAL; HERNIA, INGUINAL) and VENTRAL HERNIA.

A groin hernia occurring inferior to the inguinal ligament and medial to the FEMORAL VEIN and FEMORAL ARTERY. The femoral hernia sac has a small neck but may enlarge considerably when it enters the subcutaneous tissue of the thigh. It is caused by defects in the ABDOMINAL WALL.

The tunnel in the lower anterior ABDOMINAL WALL through which the SPERMATIC CORD, in the male; ROUND LIGAMENT, in the female; nerves; and vessels pass. Its internal end is at the deep inguinal ring and its external end is at the superficial inguinal ring.

Any woven or knit material of open texture used in surgery for the repair, reconstruction, or substitution of tissue. The mesh is usually a synthetic fabric made of various polymers. It is occasionally made of metal.

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