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Use of Human Fibrin Glue Versus Staples for Mesh Fixation in Laparoscopic Transabdominal Preperitoneal Hernioplasty

NCT01641718 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-08-08

No results posted yet for this study

Summary

Inguinal hernia repairs belong to the most common surgical procedures worldwide. Increasingly they are performed using endoscopical techniques (laparoscopy). Many surgeons prefer to cover the hernia gap with a mesh to prevent recurrence. For it, the mesh must be fixed tightly, but tension free. During laparoscopic surgery the mesh is fixed commonly with staples or tissue glue. However, it is not uncommon that staples cause pain at the staple sites while moving. In addition, staples can cause scarring of the abdominal wall leading to chronic pain.

Aim of the study is to provide evidence that mesh fixation with tissue glue causes less postoperative pain compared to fixation with staples.

Patients with unilateral inguinal hernia will be randomized to receive either mesh fixation with tissue glue or staples (ratio 1:1).

Patients with bilateral inguinal hernia will receive mesh fixation with tissue glue on one side and staple fixation on the other side. The side treated with tissue glue will be randomized (ratio 1:1).

Conditions

  • Hernia, Inguinal

Interventions

DRUG

Tissue glue

The mesh fixation for the transabdominal preperitoneal patch plastic repair will be performed with 2 mL of tissue glue.

DEVICE

Staples

The mesh fixation for the transabdominal preperitoneal patch plastic repair will be performed with ProTack (Covidien) and Securestrap (Ethicon) staples.

Sponsors & Collaborators

  • Sascha Müller

    lead OTHER

Principal Investigators

  • Sascha A Müller, MD · Cantonal Hospital St. Gallen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01641718 on ClinicalTrials.gov