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Inguinal HerniaNCT01334775

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

A study testing Open anterior inguinal hernia repair in people with Inguinal Hernia, run by Maastricht University Medical Center at 4 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Inguinal Hernia
What is being tested?
Open anterior inguinal hernia repair
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
4 sitesNetherlands
Study dates
Jun 2011to Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Female
  • Bilateral and/or recurrent inguinal hernia
  • Femoral or scrotal hernia
  • Vasectomy
  • Social status: unemployed
  • Chronic use of pain medication
Show all 10Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Academic Medical Centre Amsterdam, dept. of Surgery

    Amsterdam, 1105 AZ

  • Maastricht University Medical Centre, dept. of General Surgery

    Maastricht, 6229HX

  • Orbis Medical Centre

    Sittard-Geleen, 6162 BG

  • VieCuri Medical Centre, dept. of General Surgery

    Venlo, 5912 BL

Other trials in Netherlands

About this study

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.

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
Being tested
Open anterior inguinal hernia repair
Keywords
Inguinal hernia, Postoperative pain, Surgical mesh
Medical subject headings
Hernia, Inguinal, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open anterior inguinal hernia repairProcedure or surgery

    Also called Cousin Biotech Adhesix, Cousin Biotech Biomesh P8

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

Study groups in NCT01334775
Study groupRoleWhat they receive
Experimental - Cousin Biotech AdhesixExperimentalPlacement of a self-adhering (sutureless) surgical mesh in open anterior inguinal hernia repair
Receives: Procedure: Open anterior inguinal hernia repair
Conventional - Cousin Biotech Biomesh P8Active comparatorPlacement of the conventional (sutured) surgical mesh in open anterior inguinal hernia repair
Receives: Procedure: Open anterior inguinal hernia repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in early postoperative pain scores

    Measured with VAS-scores

    Measured: 0-4 weeks after surgery

Secondary outcomes (6)

  1. Difference in long-term postoperative pain scores

    Measured with VAS-scores

    Measured: 4 weeks - 12 months after surgery

  2. Number of days to return to normal daily activities

    Measured: 0-12 months after surgery

  3. Number of days to return to work

    Measured: 0-12 months after surgery

  4. Differences in use of analgesics

    Measured: frequency, dose and type.

    Measured: 0-12 months after surgery

  5. Differences in reported Quality of life

    Measured with SF-36 questionnaire

    Measured: 0-12 months after surgery

  6. Number of patients with complications/adverse events

    All adverse events/complications are recorded (i.e. infection, recurrence, bleeding)

    Measured: 0-12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionJun 2017
  4. Study completionJun 2017

Why it stopped: Inclusion speed too slow, no longer relevant and takeover

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01334775
Sponsor's protocol ID
NL36322.068.11
Status last verified
Apr 2011
First submitted
5 Apr 2011
Last updated
9 Jan 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Open anterior inguinal hernia repair in people with Inguinal Hernia, run by Maastricht University Medical Center at 4 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Inclusion speed too slow, no longer relevant and takeover). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in early postoperative pain scores (time frame: 0-4 weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01334775.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.

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