Chronic Postoperative Pain After Laparoendoscopic Groin Hernia Repair

Karolinska Institute

Status: Completed

Conditions: Postoperative Pain; Chronic Pain

Treatments: Procedure: Other or unspecified laparoendoscopic groin hernia repair; Procedure: TEP; Procedure: TAPP

Study type: Observational

Funder types: Other

Identifiers

NCT04838028

Bengan IV

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15,360 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15,360 participants in 9 patient groups

Standard polypropylene mesh

Description:

Density \> 50 g/square meter

Treatment:

Procedure: TAPP

Procedure: TEP

Procedure: Other or unspecified laparoendoscopic groin hernia repair

Lightweight mesh

Description:

* A mesh based on either polypropylene or polyester. Some variants contain purely 1 polymer. Others are composite, ie, contain also an absorbable material. * The density \< 50 g/square meter (when applicable, after partial absorption). * In this study, the property of light weight will trump the material, ie, any lightweight mesh having been registered as, eg, "Polyester mesh", will be reclassified as "Lightweight mesh".

Treatment:

Procedure: TAPP

Procedure: TEP

Procedure: Other or unspecified laparoendoscopic groin hernia repair

Fixation with metal tacks

Description:

Non-absorbable metal staples or tacks

Treatment:

Procedure: TAPP

Procedure: TEP

Procedure: Other or unspecified laparoendoscopic groin hernia repair

Fixation with absorbable tacks

Description:

Absorbable synthetic staples or tacks

Treatment:

Procedure: TAPP

Procedure: TEP

Procedure: Other or unspecified laparoendoscopic groin hernia repair

Fibrin glue fixation

Description:

Biologic glue/sealant produced from human donor blood

Treatment:

Procedure: TAPP

Procedure: TEP

Procedure: Other or unspecified laparoendoscopic groin hernia repair

Non-fixation

Description:

Mesh is deployed without fixation

Treatment:

Procedure: TAPP

Procedure: TEP

Procedure: Other or unspecified laparoendoscopic groin hernia repair

3D mesh

Description:

A polypropylene mesh with a preformed anatomic shape corresponding to the inner preperitoneal curvature of the groin. The category does not differentiate between standard and lightweight variants.

Treatment:

Procedure: TAPP

Procedure: TEP

Procedure: Other or unspecified laparoendoscopic groin hernia repair

Progrip fixation

Description:

Absorbable (Velcro type of) microhooks. The particular meshes come with prefabricated Progrip microhooks. Progrip = Registered trademark.

Treatment:

Procedure: TAPP

Procedure: TEP

Procedure: Other or unspecified laparoendoscopic groin hernia repair

Polyester mesh

Description:

Polyester-based mesh. This category does not differentiate between standard and lightweight variants. If a mesh was initially registered under this category by the surgeon, but identified being a lightweight mesh by the researchers, it will be re-classified as "Lightweight mesh".

Treatment:

Procedure: TAPP

Procedure: TEP

Procedure: Other or unspecified laparoendoscopic groin hernia repair