NCT04228536

Brief Summary

The goal of this study was to evaluate chronic pain and reoperation rates due to recurrence after groin hernia surgery in women compared to men and surgical method.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44,915

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 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, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
Last Updated

January 14, 2020

Status Verified

February 1, 2019

Enrollment Period

6.3 years

First QC Date

August 13, 2019

Last Update Submit

January 13, 2020

Conditions

Hernia, InguinalHernia, Femoral

Keywords

chronic pain

Outcome Measures

Primary Outcomes (2)

  • Rate of chronic pain in women 1 year after groin hernia surgery.

    Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.

    1 year after groin hernia surgery

  • Rate of chronic pain in men 1 year after groin hernia surgery.

    Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.

    1 year after groin hernia surgery

Secondary Outcomes (1)

  • Rate of reoperation for recurrence.

    Through study completion, minimum follow up 1 year

Other Outcomes (8)

  • Age as a risk factors for chronic pain after groin hernia surgery

    1 year after groin hernia surgery

  • Sex as a risk factors for chronic pain after groin hernia surgery

    1 year after groin hernia surgery

  • Hernia anatomy as a risk factors for chronic pain after groin hernia surgery

    1 year after groin hernia surgery

  • +5 more other outcomes

Interventions

Totally ExtraPeritoneal (TEP) repairPROCEDURE
TransAbdominal PrePeritoneal (TAPP) repairPROCEDURE
Open anterior mesh repair (OAM)PROCEDURE
Also known as: Lichtenstein
Combined Anterior and Posterior technique (CAP)PROCEDURE
Also known as: Plug, Prolene Hernis System (PHS), Onstep, TransInguinalPrePeritoneal repair (TIPP)
Open PrePeritoneal Mesh technique (OPPM)PROCEDURE
Also known as: Nyhus, Stoppa, Hives
Sutured RepairPROCEDURE
Also known as: McVay, Bassini, Shouldice, Marcy

Eligibility Criteria

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

All patients 15 years and older included in the SHR between 1 Sept. 2012 and 31 Aug 2017.

You may qualify if:

  • All patients 15 years and older included in the SHR between 1 Sept. 2012 and 31 Aug 2017. Both elective and acute surgery is included.

You may not qualify if:

  • Patient with bilateral operations during the study-period are only included once.

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

  • Jakobsson E, Lundstrom KJ, Holmberg H, de la Croix H, Nordin P. Chronic Pain After Groin Hernia Surgery in Women: A Patient-reported Outcome Study Based on Data From the Swedish Hernia Register. Ann Surg. 2022 Feb 1;275(2):213-219. doi: 10.1097/SLA.0000000000005194.

    PMID: 35007224DERIVED

MeSH Terms

Conditions

Hernia, InguinalHernia, FemoralChronic Pain

Interventions

tetraethylpyrazineWound Healingtetra-4-amidinophenoxypropane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Officials

  • Pär Nordin, M.D., Ph.D.

    Umeå 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

August 13, 2019

First Posted

January 14, 2020

Study Start

September 1, 2012

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

January 14, 2020

Record last verified: 2019-02