Comparison of Different Meshes in Laparoscopic Hernia Repair

Hernia, Inguinal Clinical Trial

Official title: A Randomized Controlled Trial Comparing Short Term Outcomes of Self-gripping (Progrip) Mesh With Fibrin Glue Mesh Fixation in Laparoscopic Total Extraperitoneal (TEP) Inguinal Hernia Repair

Status Completed

Clinical Trial Summary

The placement of mesh is important in hernia surgery as it helps to reduce recurrence, yet the method of fixation of mesh may cause pain after surgery. In laparoscopic hernia repair, surgeon uses different methods to fix the mesh in large hernia defects or bilateral inguinal hernias. Progrip is a special mesh developed by manufacturer that it can be self-gripped to tissue, as a result no fixation is required after placement. There are few data about Progrip in laparoscopic hernia repair. In this randomized controlled trial we would like to compare the use of Progrip with the "conventional" mesh in laparoscopic hernia repair. Surgery is performed in the usual manner; prior to placement of mesh, surgeon will get the randomization result for that particular patient: Progrip and non-Progrip group. No fixation is required for Progrip group, while fixation with fibrin glue is needed for non-Progrip group. Intraoperative data (e.g. mesh deployment time, operative time, etc) will be collected. Patients will be assessed in clinic at 2-week, 3-month, 6-month and 1-year interval after surgery. Additional visits may be arranged if considered necessary. At follow up patient will be seen by surgeon first to review the wound condition and to look for any recurrence; while other post-operative data including total analgesic usage (number of tablets), return to normal activities (days), return to work (days), pain score etc will be assessed and recorded by a trained nurse who is blinded to the treatment that patient received. Any hernia recurrence will be recorded and treated accordingly. Primary aim of this study is to look for any difference of the 2 groups in terms of postoperative pain and quality of life scores.

Clinical Trial Description

Inguinal hernia repair is one of the common surgeries performed by general surgeon all over the world. Tension-free Lichtenstein repair is the most common technique used in open repair, while many surgeons perform laparoscopic hernia repair: total extraperitoneal repair (TEP) and transabdominal preperitoneal repair (TAPP). Laparoscopic surgery is considered to reduce postoperative pain, the incidence of wound complications and time to return to activities of daily living. Both techniques are based on the principle of tension free repair and rely on mesh placement in the preperitoneal space to exclude the inguinal defect and reinforce the abdominal wall; the recurrence rate following tension-free hernia repair is reported to be low and in the range of 1-4%.

Chronic pain after an inguinal hernia repair is a well recognized complication, irrespective of technique. The incidence of chronic pain is estimated to be around 5-10%. Many factors contributed to the development of chronic pain, and one of the factors being the type of mesh fixation method. Common types of mesh fixation methods in laparoscopic hernia repair are traumatic fixation - the use of tacks (absorbable or non-absorbable) or atraumatic fixation, e.g. the use of fibrin glue; while some surgeons do not fix the mesh. No fixation is practiced by some surgeons in unilateral repair as some studies showed that there was no difference in recurrence rate and incidence of chronic pain between fixation or no fixation groups, yet in these studies hernia opening was small (<3cm) or not measured. It is generally agreed that fixation is indicated in large hernias (defect size >3cm), bilateral hernias and recurrent hernias in order to avoid early mesh dislocation and hernia recurrence.

Study has shown that the use of tacks caused more early postoperative pain. Manufacturers try to develop self-gripping mesh with the aim to reduce chronic pain. ProgripTM (Covidien) is a lightweight, self-gripping mesh composed of monofilament polyester and polylactic acid (PLA) microgrips indicated for inguinal hernia repair. The resorbable microgrips provide immediate adherence to surrounding muscle and adipose tissue during hernia surgery, as a result no fixation method is required. Studies have shown that ProgripTM is associated with less pain in the early recovery period when used in open Lichtenstein repair, yet there are few studies of ProgripTM in laparoscopic hernia repair.

In Hong Kong, TEP is the preferred approach for most surgeons who perform laparoscopic hernia surgery. In this trial, patients with inguinal hernia who is suitable for TEP are recruited. TEP will be performed in the usual manner. Surgeon will assess the size of hernia defect prior to mesh insertion. For patients with large hernia defect or bilateral inguinal hernia that required mesh fixation, they will be randomized in two groups: ProgripTM and non-ProgripTM group. For ProgripTM no addition fixation is necessary, while for non-ProgripTM fixation is indicated. As tacks are known to be associated with postoperative pain, fibrin glue is designated as the fixation method in non- ProgripTM group in this study. ;

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

• NCT number: NCT02712827
• Study type: Interventional
• Source: The University of Hong Kong
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Completion date: July 2018