Chronic Postoperative Pain After Laparoscopic Groin Hernia Repair

Completed

• Conditions: Chronic Pain; Postoperative Pain
• Interventions: Procedure: TEP; Procedure: TAPP

• 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

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: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24680

Inclusion Criteria

All laparoscopic TEP and TAPP repairs that have been registered in the SHR from September 1, 2012, until December 31, 2018.

Read More

Exclusion Criteria

• Open repairs.
• Hernioplasties that were converted from laparoscopic to open surgery.
• Previous hernioplasty in the same groin
• 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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lightweight mesh	TEP	* 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)
Fixation with absorbable tacks	TEP	Absorbable synthetic staples or tacks
Non-fixation	TEP	Mesh is deployed without fixation
Non-fixation	TAPP	Mesh is deployed without fixation
Standard polypropylene mesh	TEP	Density \> 50 g/square meter
Standard polypropylene mesh	TAPP	Density \> 50 g/square meter
Fibrin glue fixation	TAPP	Biologic glue/sealant produced from human donor blood
Progrip fixation	TAPP	Absorbable (Velcro type of) microhooks. The particular meshes come with prefabricated Progrip microhooks. Progrip = Registered trademark.
Polyester mesh	TEP	Polyester-based mesh. This category does not differentiate between standard and lightweight variants
Lightweight mesh	TAPP	* 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)
Fixation with metal tacks	TEP	Non-absorbable metal staples or tacks
Fixation with metal tacks	TAPP	Non-absorbable metal staples or tacks
Fixation with absorbable tacks	TAPP	Absorbable synthetic staples or tacks
Fibrin glue fixation	TEP	Biologic glue/sealant produced from human donor blood
Polyester mesh	TAPP	Polyester-based mesh. This category does not differentiate between standard and lightweight variants
3D mesh	TEP	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.
3D mesh	TAPP	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.
Progrip fixation	TEP	Absorbable (Velcro type of) microhooks. The particular meshes come with prefabricated Progrip microhooks. Progrip = Registered trademark.

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