Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty

November 30, 2022 updated by: Bengt Novik, Karolinska Institutet

Mesh and Fixation Combinations in the Lichtenstein Groin Hernioplasty: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study.

The study attempts to quantify the relative risks for chronic postoperative inguinal pain (CPIP) after Lichtenstein repair of groin hernia, depending on mesh type and fixation suture material.

For this purpose the investigators will analyze data from the Swedish Hernia Registry (SHR).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in SHR, which covers > 95% of all groin hernia repairs in Sweden. The large database enables assessment of the relative risks for CPIP depending on in particular mesh and mesh fixation, adjusted for other plausible risk factors.

Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. One year postop, each patient was sent a questionnaire focusing on present pain.

Study Type

Observational

Enrollment (Actual)

80733

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

An unselected, consecutive nationwide cohort during 7 years, with a 1-year follow-up

Description

Inclusion Criteria:

All Lichtenstein and similar open mesh repairs that have been registered in the SHR from September 1, 2012, until December 31, 2018.

Exclusion Criteria:

  • Laparoscopic repairs.
  • Preperitoneal open repairs.
  • Pure suture repairs
  • Patients not having a 10-digit state-assigned Patient Identification Number.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fibrin glue
Biologic glue/sealant produced from human donor blood
Device: Lichtenstein mesh repair
A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures
Permanent suture
Mesh fixation with permanent suture
Device: Lichtenstein mesh repair
A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures
Long-term absorbable
Mesh fixation with long-term absorbable suture
Device: Lichtenstein mesh repair
A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures
Short-term absorbable
Mesh fixation with short-term absorbable suture
Device: Lichtenstein mesh repair
A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures
Progrip
Pre-fabricated absorbable fixation hooks, integrated in mesh. Progrip is a registered trademark owned by Medtronic
Device: Lichtenstein mesh repair
A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPIP
Time Frame: 1 year
Chronic postoperative inguinal pain
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Uppsala University
Swedish Hernia Registry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2012

Primary Completion (ACTUAL)

November 6, 2019

Study Completion (ACTUAL)

November 6, 2020

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (ACTUAL)

April 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bengan V

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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