Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery

Completed

• Conditions: Laparoscopy; Fixation Device; Complications; Hernia, Inguinal; Hernia; Hernia, Femoral; Surgical Procedures, Minimally Invasive; Surgical Staplers; Recurrence; Surgical Mesh

• Registration Number: NCT03755219
• Lead Sponsor: Bengt Novik

Brief Summary

The study attempts to quantify the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type.

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 more than 38,000 TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enables assessment of the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type, with fulfilling statistical power.

Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. Reoperations were registered in the SHR in the same manner as index repairs, and were used as endpoints.

Study Timeline

• Study Start: 2005-01-01
• Primary Completion: 2017-12-31
• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-27
• Study Completion: 2018-12-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38450

Inclusion Criteria

• All laparoscopic (mainly TEP and TAPP) repairs that have been registered in the SHR from January 1, 2005 until December 31, 2018.

Exclusion Criteria

• Open repairs.
• Hernioplasties that were converted from laparoscopic to open surgery.
• 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
Death	Assessment at Dec 31, 2018	The date of death
Reoperation for recurrence	Assessment at Dec 31, 2018	The date of the recurrent surgery