Comparison of Self-adhering Mesh and Conventional Mesh in Inguinal Hernia Repair.

NCT01334775 | Terminated

• 1 other identifier: NL36322.068.11
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

Brief Summary

Inguinal hernia repair coincides with a high rate of postoperative pain, extending to over a year in 10-20% of patients. Although this is of major concern, early postoperative pain also has an important impact on patients and their ability to regain normal work and activities. Since inguinal hernia repair is the most frequently performed operation worldwide, a small reduction in loss of workdays can already have significant impact on financial issues. As for the origin of the pain, it might be the result of local inflammation caused by the mesh material, but also by nerve entrapment due to fixation techniques. The development of a new mesh which enables sutureless fixation, Cousin Biotech® Adhesix™, may overcome pain related to fixation techniques used in the open hernia repair procedure according to Lichtenstein. Furthermore, the Cousin Biotech® Adhesix™ mesh has already been in use in our institutions and surgeons familiarized themselves with the application. The investigators would like to conduct a multicentre randomised controlled clinical trial to compare the difference in early postoperative pain after unilateral primary inguinal hernia repair in males. The procedures will be performed in day surgery. Early postoperative pain is defined as the pain during the first month, with a special interest in the first two weeks. In addition, the investigators want to measure the possible benefit in terms of time to return to work, daily activities, quality of life, operation length, complications and long term postoperative pain.

Conditions

Inguinal Hernia

Keywords

Inguinal hernia; Postoperative pain; Surgical mesh

Outcome Measures

Primary Outcomes (1)

• Difference in early postoperative pain scores

  Measured with VAS-scores

  0-4 weeks after surgery

Secondary Outcomes (6)

• Difference in long-term postoperative pain scores

  4 weeks - 12 months after surgery

• Number of days to return to normal daily activities

  0-12 months after surgery

• Number of days to return to work

  0-12 months after surgery

• Differences in use of analgesics

  0-12 months after surgery

• Differences in reported Quality of life

  0-12 months after surgery

Study Arms (2)

Experimental - Cousin Biotech Adhesix

EXPERIMENTAL

Placement of a self-adhering (sutureless) surgical mesh in open anterior inguinal hernia repair

Procedure: Open anterior inguinal hernia repair

Conventional - Cousin Biotech Biomesh P8

ACTIVE COMPARATOR

Placement of the conventional (sutured) surgical mesh in open anterior inguinal hernia repair

Procedure: Open anterior inguinal hernia repair

Interventions

Open anterior inguinal hernia repair PROCEDURE

Placement of a surgical mesh in open anterior inguinal hernia repair.

Also known as: Cousin Biotech Adhesix, Cousin Biotech Biomesh P8

Conventional - Cousin Biotech Biomesh P8; Experimental - Cousin Biotech Adhesix

Eligibility Criteria

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

You may qualify if:

• Male
• Primary, unilateral inguinal hernia
• Age ≥18 years
• Social status: professionally employed
• ASA-score I-III
• Signed informed consent
• Elective surgery

You may not qualify if:

• Female
• Bilateral and/or recurrent inguinal hernia
• Femoral or scrotal hernia
• Vasectomy
• Social status: unemployed
• Chronic use of pain medication
• Symptomatic acute hernia (i.e. bowel obstruction, incarceration, strangulation, peritonitis or perforation of bowel contents)
• ASA-score IV or above
• Incapacitated adult or no signed informed consent
• Patient is unable to speak Dutch

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Orbis Medical Centre: collaborator
• VieCuri Medical Centre: collaborator

Study Sites (4)

Academic Medical Centre Amsterdam, dept. of Surgery

Amsterdam, 1105 AZ, Netherlands

Location

Maastricht University Medical Centre, dept. of General Surgery

Maastricht, 6229HX, Netherlands

Location

Orbis Medical Centre

Sittard-Geleen, 6162 BG, Netherlands

Location

VieCuri Medical Centre, dept. of General Surgery

Venlo, 5912 BL, Netherlands

Location

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Nicole D. Bouvy, MD, PhD

  Maastricht University Medical Centre, dept. of General Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 13, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 9, 2018

Record last verified: 2011-04

Locations

NL (4)