NCT02419950

Brief Summary

Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain. A cohort of patients were studied for pain interfering with sexual activety. The hyopthesis is that fixation causes pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,110

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

1.5 years

First QC Date

September 24, 2014

Last Update Submit

April 14, 2015

Conditions

Inguinal Hernia

Keywords

inguinal herniaTEPchronic painmale sexmesh fixationquality of lifenational register

Outcome Measures

Primary Outcomes (1)

  • Chronic pain

    Chronic pain is meassured using an Enquirer sent to the patients by mail containing general questions to be able to exclude patients having a chronic pain problem due to other causes than the hernia (like back pain and other operations in the area) SF 36 questionnair for global measures of physical and mental Health and an validated inguinal hernia specific questionnaire for measuring pain, IPQ (Inguinal Pain Questionnair) was used

    5 years

Secondary Outcomes (2)

  • Sexual problems due to inguinal pain problems after hernia surgery

    2-5 years

  • A second operation for a recurrence

    5-7 years

Study Arms (2)

No fixation of mesh in TEP

Patient having no mechanical fixation of the mesh in TEP. This will include both no fixation at all och glue fixation of the mesh in total extraperitoneal placement of mesh by endoscopic technique

Device: Fixation of mesh in TEP

Fixation of mesh in TEP

Patients having fixation of the mesh using mechanical, non absorbable fixating devices.This will include mechanical fixation of the mesh in total extraperitoneal placement of mesh by endoscopic technique

Device: Fixation of mesh in TEP

Interventions

Fixation of mesh in TEPDEVICE

An endoscopic operative technique were mesh for preperitonelal placement in patients with inguinal hernias can be fixated in Place or left without fixation

Also known as: Total Extraperitoneal Patch
Fixation of mesh in TEPNo fixation of mesh in TEP

Eligibility Criteria

Age30 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men between 30-75 years with primary inguinal hernia

You may qualify if:

  • Male between 30-75 years.
  • Primary inguinal hernia

You may not qualify if:

  • Emergency operation
  • Operated for recurrence
  • Deaths

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lund,

Malmo, 20502, Sweden

Location

Related Publications (5)

  • Franneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyren O, Sandblom G. Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93. doi: 10.1002/bjs.6014.

    PMID: 18161900BACKGROUND

  • Kehlet H, Bay-Nielsen M, Kingsnorth A. Chronic postherniorrhaphy pain--a call for uniform assessment. Hernia. 2002 Dec;6(4):178-81. doi: 10.1007/s10029-002-0082-0. Epub 2002 Sep 20.

    PMID: 12424597BACKGROUND

  • Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.

    PMID: 16862612BACKGROUND

  • Aasvang EK, Mohl B, Bay-Nielsen M, Kehlet H. Pain related sexual dysfunction after inguinal herniorrhaphy. Pain. 2006 Jun;122(3):258-263. doi: 10.1016/j.pain.2006.01.035. Epub 2006 Mar 20.

    PMID: 16545910BACKGROUND

  • Kaul A, Hutfless S, Le H, Hamed SA, Tymitz K, Nguyen H, Marohn MR. Staple versus fibrin glue fixation in laparoscopic total extraperitoneal repair of inguinal hernia: a systematic review and meta-analysis. Surg Endosc. 2012 May;26(5):1269-78. doi: 10.1007/s00464-011-2025-2. Epub 2012 Feb 21.

    PMID: 22350225BACKGROUND

MeSH Terms

Conditions

Hernia, InguinalChronic Pain

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Agneta Montgomery, MD, PhD

    University of Lund, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD

Study Record Dates

First Submitted

September 24, 2014

First Posted

April 17, 2015

Study Start

November 1, 2008

Primary Completion

May 1, 2010

Study Completion

September 1, 2013

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

SE(1)