Chronic Postoperative Pain After Laparoendoscopic Groin Hernia Repair

Completed

• Conditions: Chronic Pain; Postoperative Pain

• Registration Number: NCT04838028
• Lead Sponsor: Karolinska Institutet

Brief Summary

The study attempts to quantify the relative risks for chronic postoperative inguinal pain (CPIP) depending on different combinations of mesh and mesh fixation. 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 the Swedish Hernia Registry (SHR), which covers \> 95% of all groin hernia repairs in Sweden. The very large cohort of approximately 25,000 primary TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enable assessment of the relative risks for CPIP depending on different combinations of mesh and mesh fixation. Each participant was entered at the date of surgery when demographic and intraoperative data were registered. The possible presence of CPIP after 1 year postoperative was evaluated with a PROM questionnaire.

Study Timeline

• Study Start: 2012-09-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-11-06
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15360

Inclusion Criteria

All laparoendoscopic repairs for groin hernia that have been registered in the SHR from September 1, 2012, until December 31, 2018.

Exclusion Criteria

• Open repairs.
• Hernioplasties that were converted from laparoscopic to open surgery.
• Bilateral repairs.
• Surgery merely for hernia (eg obturator) other than lateral, medial or femoral.
• Age < 15 years.
• Patients not having a 10-digit state-assigned Patient Identification Number.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative risk for postoperative pain at 1 year	1 year	Chronic postoperative inguinal pain, measured by the Short Form Inguinal Pain Questionnaire (sf-IPQ)

Secondary Outcome Measures

Name	Time	Method
Reoperation	1-8 years	Reoperation due to recurrence, during the study period