Comparison of Different Meshes in Laparoscopic Hernia Repair

NCT ID: NCT02712827

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-07-31

Brief 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.

Detailed 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.

Conditions

Hernia, Inguinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Progrip

The Progrip group is the intervention group. Patients will undergo laparoscopic total extraperitoneal repair of inguinal hernia. The surgeon will use a self-gripping mesh to repair the hernia. No fixation is required for the mesh.

Group Type: EXPERIMENTAL

Progrip

Intervention Type: PROCEDURE

Self-fixating mesh

Non-Progrip

The Non-Progrip group is the control group.

Operation is performed under general anesthesia. A standard three-trocar technique is used: one infra-umbilical camera trocar (1cm) and two 5mm trocars placed at midline between the umbilicus and pubic bone (or one at the side of inguinal hernia). A laparoscope is inserted to the preperitoneal space through the incision. The space is insufflated with carbon dioxide. Dissection is performed, hernia content (if any) is reduced.

A non self-gripping synthetic mesh is placed. Fibrin glue is used for fixation.

Group Type: ACTIVE_COMPARATOR

Non-Progrip

Intervention Type: PROCEDURE

Non self-fixating mesh with the use of glue

Interventions

Progrip

Self-fixating mesh

Intervention Type: PROCEDURE

Non-Progrip

Non self-fixating mesh with the use of glue

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age≥18
• Unilateral inguinal hernia with large hernia defect size (>3cm)
• Bilateral inguinal hernias
• American Society of Anesthesiologists (ASA) score: 1-2
• Provision of written informed consent

Exclusion Criteria

• Any prior surgery for ipsilateral inguinal hernia (i.e. recurrent inguinal hernia)
• American Society of Anesthesiologists (ASA) score: 3 or above
• History of major abdominal surgery that may result in difficulty in development of preperitoneal space
• Subject is pregnant or breast feeding
• Any serious concomitant illness with short life expectancy
• Subject who is not able to attend follow up postoperatively

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Dominic C.C. Foo

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominic, Chi Chung Foo, MBBS

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Tung Wah Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

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Other Identifiers

UW 16-042

Identifier Type: -

Identifier Source: org_study_id