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

Comparison of Cousin Biotech® Adhesix™ Versus Conventional Mesh in Open Anterior Inguinal Hernia Repair: a Multi-centre, Randomised, Double-blinded, Controlled Clinical Trial.

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.

Study Overview

• Status: Terminated
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Open anterior inguinal hernia repair

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academic Medical Centre Amsterdam, dept. of Surgery
  • Maastricht, Netherlands, 6229HX
    • Maastricht University Medical Centre, dept. of General Surgery
  • Sittard-Geleen, Netherlands, 6162 BG
    • Orbis Medical Centre
  • Venlo, Netherlands, 5912 BL
    • VieCuri Medical Centre, dept. of General Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental - Cousin Biotech Adhesix; Placement of a self-adhering (sutureless) surgical mesh in open anterior inguinal hernia repair	Procedure: Open anterior inguinal hernia repair; Placement of a surgical mesh in open anterior inguinal hernia repair.; Other Names: Cousin Biotech Adhesix; Cousin Biotech Biomesh P8
Active Comparator: Conventional - Cousin Biotech Biomesh P8; Placement of the conventional (sutured) surgical mesh in open anterior inguinal hernia repair	Procedure: Open anterior inguinal hernia repair; Placement of a surgical mesh in open anterior inguinal hernia repair.; Other Names: Cousin Biotech Adhesix; Cousin Biotech Biomesh P8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in early postoperative pain scores	Measured with VAS-scores	0-4 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in long-term postoperative pain scores	Measured with VAS-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	Measured: frequency, dose and type.	0-12 months after surgery
Differences in reported Quality of life	Measured with SF-36 questionnaire	0-12 months after surgery
Number of patients with complications/adverse events	All adverse events/complications are recorded (i.e. infection, recurrence, bleeding)	0-12 months after surgery

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); VieCuri Medical Centre; Orbis Medical Centre
• Investigators: Principal Investigator: Nicole D. Bouvy, MD, PhD, Maastricht University Medical Centre, dept. of General Surgery

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: April 5, 2011
• First Submitted That Met QC Criteria: April 12, 2011
• First Posted (Estimate): April 13, 2011

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Inguinal hernia; Postoperative pain; Surgical mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: NL36322.068.11