Comparison of Self-adhering Mesh and Conventional Mesh in... | NCT01334775

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

NCT01334775

Sponsor

Maastricht University Medical Center

Status

Terminated

Last Update Posted

Jan 9, 2018Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Inguinal Hernia

Interventions

Open anterior inguinal hernia repair

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inclusion speed too slow, no longer relevant and takeover

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Apr 5, 2011

First Submission Date that Met QC Criteria

Apr 12, 2011

First Posted Date

Apr 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2018

Last Update Posted Date

Jan 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Maastricht University Medical CenterOTHER

Collaborators

Name	Class
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	OTHER
Orbis Medical Centre	OTHER
VieCuri Medical Centre	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Open anterior inguinal hernia repair	Procedure	Placement of a surgical mesh in open anterior inguinal hernia repair.	Conventional - Cousin Biotech Biomesh P8 Experimental - Cousin Biotech Adhesix

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicole D. Bouvy, MD, PhD	Maastricht University Medical Centre, dept. of General Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academic Medical Centre Amsterdam, dept. of Surgery		Amsterdam		1105 AZ	Netherlands
Maastricht University Medical Centre, dept. of General Surgery

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided