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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01334775
• Other study ID #: NL36322.068.11
• Status: Terminated
• Phase: N/A
• First received: April 5, 2011
• Last updated: January 5, 2018
• Start date: June 2011
• Est. completion date: June 2017

Study information

• Verified date: April 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Open anterior inguinal hernia repair
Placement of a surgical mesh in open anterior inguinal hernia repair.

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre Amsterdam, dept. of Surgery	Amsterdam
Netherlands	Maastricht University Medical Centre, dept. of General Surgery	Maastricht
Netherlands	Orbis Medical Centre	Sittard-Geleen
Netherlands	VieCuri Medical Centre, dept. of General Surgery	Venlo

Sponsors (4)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Orbis Medical Centre, VieCuri Medical Centre

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in early postoperative pain scores	Measured with VAS-scores	0-4 weeks after surgery
Secondary	Difference in long-term postoperative pain scores	Measured with VAS-scores	4 weeks - 12 months after surgery
Secondary	Number of days to return to normal daily activities		0-12 months after surgery
Secondary	Number of days to return to work		0-12 months after surgery
Secondary	Differences in use of analgesics	Measured: frequency, dose and type.	0-12 months after surgery
Secondary	Differences in reported Quality of life	Measured with SF-36 questionnaire	0-12 months after surgery
Secondary	Number of patients with complications/adverse events	All adverse events/complications are recorded (i.e. infection, recurrence, bleeding)	0-12 months after surgery