NCT02751190

Brief Summary

In the present study the investigators aimed to investigate the relationship between surgical methods and chronic pain in over 20 000 patients who underwent groin hernia repair in Sweden

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24,607

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

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

September 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 24, 2017

Status Verified

April 1, 2016

Enrollment Period

2.5 years

First QC Date

April 8, 2016

Last Update Submit

February 22, 2017

Conditions

Hernia, InguinalHernia, Femoral

Outcome Measures

Primary Outcomes (1)

  • Chronic post herniorraphy pain

    A IPQ score of \> 3. Pain, which could not be ignored and affected concentration on activities and leisure activities

    1 year

Secondary Outcomes (1)

  • Reoperation for recurrence

    Up to 4 years from primary surgery

Interventions

Totally ExtraPeritoneal (TEP) repairPROCEDURE
TransAbdominal PrePeritoneal (TAPP) repairPROCEDURE
Open anterior mesh repairPROCEDURE
Also known as: Lichtenstein repair
Open Anterior Non MeshPROCEDURE
Also known as: McVay, Bassani, Shouldice, Marcy
Combined anterior and posterior repairPROCEDURE
Also known as: Plug, Prolene Hernis System (PHS), Onstep, TransInguinalPrePeritoneal repair (TIPP)
Open preperitoneal mesh repairPROCEDURE
Also known as: Nyhus, Stoppa, Rives

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients registered in the Swedish hernia surgery.

You may qualify if:

  • Unilateral, elective, groin hernia repair

You may not qualify if:

  • Bilateral hernia repair
  • Emergent repair (\<24h of duration with signs of incarceration)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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

  • Nilsson E, Haapaniemi S. Assessing the quality of hernia repair. In: Fitzgibbons RJ, Nyhus LM, eds. Hernia. Philadelphia: Lippincott Williams and Wilkins, 2002:567-73.

    BACKGROUND

MeSH Terms

Conditions

Hernia, InguinalHernia, Femoral

Interventions

tetraethylpyrazineWound Healingtetra-4-amidinophenoxypropane

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Officials

  • Pär Nordin, MD.Ph.D

    Umea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 26, 2016

Study Start

September 1, 2013

Primary Completion

March 1, 2016

Study Completion

February 1, 2017

Last Updated

February 24, 2017

Record last verified: 2016-04