Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty

Completed

• Conditions: Postoperative Pain; Chronic Pain; Suture Related Complication; Hernia, Inguinal; Hernia, Femoral; PROM
• Interventions: Device: Lichtenstein mesh repair

• Registration Number: NCT04839848
• Lead Sponsor: Karolinska Institutet

Brief Summary

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).

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2012-09-01
• Primary Completion: 2019-11-06
• Study Completion: 2020-11-06
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80733

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fibrin glue	Lichtenstein mesh repair	Biologic glue/sealant produced from human donor blood
Permanent suture	Lichtenstein mesh repair	Mesh fixation with permanent suture
Long-term absorbable	Lichtenstein mesh repair	Mesh fixation with long-term absorbable suture
Short-term absorbable	Lichtenstein mesh repair	Mesh fixation with short-term absorbable suture
Progrip	Lichtenstein mesh repair	Pre-fabricated absorbable fixation hooks, integrated in mesh. Progrip is a registered trademark owned by Medtronic

Primary Outcome Measures

Name	Time	Method
CPIP	1 year	Chronic postoperative inguinal pain