Glubran Mesh Fixation in Lichtenstein Hernioplasty

NCT ID: NCT00659542

Last Updated: 2010-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-12-31

Brief Summary

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The purpose of the study is to investigate whether chronic postoperative pain is less frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared to conventional sutures in inguinal hernioplasty.

Detailed Description

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Repair of inguinal hernia in one of the most frequently performed surgical operation in western world. The technique of choice is currently to support inguinal tissues by using polypropylene mesh. Chronic postoperative pain and discomfort occur in 25-30% of patients after inguinal hernioplasty. Pain might be related to mesh fixation by sutures. This randomized study investigates whether mesh fixation by tissue glue (cyanoacrylate) is better than sutures. The patients are followed 1 year postoperatively. Pain, quality of life, operative parameters (time, cost) and recurrences are reported.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

mesh fixation by absorbable sutures

Group Type NO_INTERVENTION

No interventions assigned to this group

2

mesh fixation by cyanoacrylate glue

Group Type EXPERIMENTAL

cyanoacrylate glue

Intervention Type PROCEDURE

1 ml glue

Interventions

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cyanoacrylate glue

1 ml glue

Intervention Type PROCEDURE

Other Intervention Names

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Glubran2 synthetic surgical glue

Eligibility Criteria

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Inclusion Criteria

* inguinal hernia
* adult patient

Exclusion Criteria

* patient not willing
* multiple recurrences
* inguinal pain without evidence of hernia
* femoral hernia
* large scrotal hernia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Karelia Central Hospital

OTHER

Sponsor Role collaborator

Paijat-Hame Hospital District

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Surgery, Kuopio University Hospital, Finland

Principal Investigators

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Pekka Miettinen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University hospital of Kuopio, Finland

Locations

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Hannu Paajanen

Kuopio, Kuopio, Finland

Site Status

Countries

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Finland

References

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Ong CC, Jacobsen AS, Joseph VT. Comparing wound closure using tissue glue versus subcuticular suture for pediatric surgical incisions: a prospective, randomised trial. Pediatr Surg Int. 2002 Sep;18(5-6):553-5. doi: 10.1007/s00383-002-0728-0. Epub 2002 Jun 14.

Reference Type BACKGROUND
PMID: 12415411 (View on PubMed)

Matikainen M, Kossi J, Silvasti S, Hulmi T, Paajanen H. Randomized Clinical Trial Comparing Cyanoacrylate Glue Versus Suture Fixation in Lichtenstein Hernia Repair: 7-Year Outcome Analysis. World J Surg. 2017 Jan;41(1):108-113. doi: 10.1007/s00268-016-3801-x.

Reference Type DERIVED
PMID: 27864616 (View on PubMed)

Paajanen H, Kossi J, Silvasti S, Hulmi T, Hakala T. Randomized clinical trial of tissue glue versus absorbable sutures for mesh fixation in local anaesthetic Lichtenstein hernia repair. Br J Surg. 2011 Sep;98(9):1245-51. doi: 10.1002/bjs.7598. Epub 2011 Jun 28.

Reference Type DERIVED
PMID: 21710480 (View on PubMed)

Other Identifiers

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cyanoacrylate1

Identifier Type: -

Identifier Source: secondary_id

KUH5204518

Identifier Type: -

Identifier Source: org_study_id

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