Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty

Karolinska Institute

Status: Completed

Conditions: Postoperative Pain; Hernia, Femoral; Hernia, Inguinal; Chronic Pain; Suture Related Complication; PROM

Treatments: Device: Lichtenstein mesh repair

Study type: Observational

Funder types: Other

Identifiers

NCT04839848

Bengan V

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80,733 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

80,733 participants in 5 patient groups

Permanent suture

Description:

Mesh fixation with permanent suture

Treatment:

Device: Lichtenstein mesh repair

Long-term absorbable

Description:

Mesh fixation with long-term absorbable suture

Treatment:

Device: Lichtenstein mesh repair

Short-term absorbable

Description:

Mesh fixation with short-term absorbable suture

Treatment:

Device: Lichtenstein mesh repair

Fibrin glue

Description:

Biologic glue/sealant produced from human donor blood

Treatment:

Device: Lichtenstein mesh repair

Progrip

Description:

Pre-fabricated absorbable fixation hooks, integrated in mesh. Progrip is a registered trademark owned by Medtronic

Treatment:

Device: Lichtenstein mesh repair