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
• Interventions: Procedure: TEP; Procedure: TAPP

• 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

Arm && Interventions

Group	Intervention	Description
Tacks, absorbable	TEP	Absorbable synthetic staples or tacks. Material specification of staples/tacks was introduced in SHR 2012.
StdPPM	TAPP	Standard pure polypropylene mesh. "Standard" is defined in SHR by weight ≥ 50 g/square meter.
LWM	TAPP	Lightweight mesh: Either a pure polypropylene mesh, or a polypropylene-based composite mesh. The study uses SHR's classification of "light-weight" = \<50 g/square meter.
LWM	TEP	Lightweight mesh: Either a pure polypropylene mesh, or a polypropylene-based composite mesh. The study uses SHR's classification of "light-weight" = \<50 g/square meter.
Tacks, absorbable	TAPP	Absorbable synthetic staples or tacks. Material specification of staples/tacks was introduced in SHR 2012.
Fibrin glue	TEP	Biologic glue/sealant produced from human donor blood
StdPPM	TEP	Standard pure polypropylene mesh. "Standard" is defined in SHR by weight ≥ 50 g/square meter.
Tacks, metal	TEP	Metal staples or tacks. Material specification of staples/tacks was introduced in SHR 2012.
Tacks, uncategorized	TEP	Staples or tacks were in SHR 2005-2011 not further categorized. This category also includes staples/tacks registered from 2012 and forth, not being specified as either metal or absorbable.
Tacks, uncategorized	TAPP	Staples or tacks were in SHR 2005-2011 not further categorized. This category also includes staples/tacks registered from 2012 and forth, not being specified as either metal or absorbable.
Fibrin glue	TAPP	Biologic glue/sealant produced from human donor blood
Tacks, metal	TAPP	Metal staples or tacks. Material specification of staples/tacks was introduced in SHR 2012.
Non-fixation	TAPP	Mesh is deployed without fixation
Non-fixation	TEP	Mesh is deployed without fixation
3D Mesh	TEP	Mesh categorized by anatomical shaped, rather than material or weight. Therefore, this category will be excluded in the original study. Depending on the volume of casess found, the 3D mesh category may eventually be analyzed separately in another study..
3D Mesh	TAPP	Mesh categorized by anatomical shaped, rather than material or weight. Therefore, this category will be excluded in the original study. Depending on the volume of casess found, the 3D mesh category may eventually be analyzed separately in another study..

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