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

NCT01641718 | Completed

• 1 other identifier: TISTA
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

• Pain after physical stress

  Patient rates his pain on a scale from 0 to 10 (10 equals worst pain imaginable). (NRS numeric rating scale). Patient will be asked to bend the hip joint for 90° on the operated side (both sides for patients with bilateral hernia). Then they are asked for the pain rating (physical stress measurement).

  24 h after surgery

Secondary Outcomes (9)

• Pain at rest

  4, 8, 16, 24, 32, 48 h & 1 month after surgery

• Pain after physical stress

  4, 8, 16, 32, 48 h & 1 month after surgery

• Operating time

  4 h

• Length of hospital stay

  2 weeks

• Postoperative analgetic requirements

  1 month

Study Arms (4)

Single sided glue

EXPERIMENTAL

Mesh is fixed with Tisseel for single sided inguinal hernias.

Drug: Tissue glue

Single sided stapled

ACTIVE COMPARATOR

Mesh is fixed with staples for single sided inguinal hernias.

Device: Staples

Bilateral glue right

OTHER

For bilateral inguinal hernias mesh on the right side is fixed with Tisseel, on the left with staples. Experimental treatment and active comparator in the same patient.

Drug: Tissue glue; Device: Staples

Bilateral glue left

OTHER

For bilateral inguinal hernias mesh on the left side is fixed with Tisseel, on the right with staples. Experimental treatment and active comparator in the same patient.

Drug: Tissue glue; Device: Staples

Interventions

Tissue glue DRUG

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

Also known as: Tisseel (Baxter)

Bilateral glue left; Bilateral glue right; Single sided glue

Staples DEVICE

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

Also known as: ProTack (Covidien), Securestrap (Ethicon)

Bilateral glue left; Bilateral glue right; Single sided stapled

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary hernia repair (no re-operation for recurrent hernia)
• good compliance can be expected
• informed consent

You may not qualify if:

• chronic pain
• acute pain requiring analgesic others than paracetamol or more than a single dose non-steroidal anti-inflammatory drugs treatment within 48 h before surgery
• current treatment with psychopharmaceutical drugs
• mental incapacity
• known incompatibility (allergies) with the Tisseel compounds

Sponsors & Collaborators

• Sascha Müller: lead

Study Sites (1)

Cantonal Hospital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

Related Publications (1)

• Muller SA, Warschkow R, Beutner U, Luthi C, Ukegjini K, Schmied BM, Tarantino I. Use of human fibrin glue (Tisseel) versus staples for mesh fixation in laparoscopic transabdominal preperitoneal hernioplasty (TISTA): a randomized controlled trial (NCT01641718). BMC Surg. 2014 Apr 1;14:18. doi: 10.1186/1471-2482-14-18.

  PMID: 24690207 BACKGROUND

Related Links

• Website of the Department of Surgery, Cantonal Hospital St. Gallen (German only)

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Fibrin Tissue Adhesive; Sutures

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Sascha A Müller, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Oberarzt (attending physician)

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 17, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

CH (1)