Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT04839848
• Collaborator: Uppsala University (Other), Swedish Hernia Registry (Other)
• Enrollment: 81,628
• Actual Duration (Months): 98.2

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Hernia, Inguinal; Hernia, Femoral; Postoperative Pain; Chronic Pain; PROM; Suture Related Complication	Device: Lichtenstein mesh repair

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 81628 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Mesh and Fixation Combinations in the Lichtenstein Groin Hernioplasty: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study.
• Actual Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Nov 6, 2019
• Actual Study Completion Date: Nov 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Permanent suture Mesh fixation with permanent suture	Device: Lichtenstein mesh repair; A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures
Long-term absorbable Mesh fixation with long-term absorbable suture	Device: Lichtenstein mesh repair; A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures
Short-term absorbable Mesh fixation with short-term absorbable suture	Device: Lichtenstein mesh repair; A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures
Fibrin glue Biologic glue/sealant produced from human donor blood	Device: Lichtenstein mesh repair; A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures
Progrip Pre-fabricated absorbable fixation hooks, integrated in mesh. Progrip is a registered trademark owned by Medtronic	Device: Lichtenstein mesh repair; A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures

Outcome Measures

Primary Outcome Measures

1. CPIP [1 year]

   Chronic postoperative inguinal pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

All Lichtenstein and similar open mesh repairs that have been registered in the SHR from September 1, 2012, until November 11, 2019.

Exclusion Criteria:

• Laparoscopic repairs.

• Preperitoneal open repairs.

• Pure suture repairs

• Patients not having a 10-digit state-assigned Patient Identification Number.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Karolinska Institutet
• Uppsala University
• Swedish Hernia Registry

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Fränneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyrén O, Sandblom G. Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93.
• Novik B, Hagedorn S, Mörk UB, Dahlin K, Skullman S, Dalenbäck J. Fibrin glue for securing the mesh in laparoscopic totally extraperitoneal inguinal hernia repair: a study with a 40-month prospective follow-up period. Surg Endosc. 2006 Mar;20(3):462-7. Epub 2006 Jan 19. Erratum in: Surg Endosc. 2022 May;36(5):3675.
• Novik B, Nordin P, Skullman S, Dalenbäck J, Enochsson L. More recurrences after hernia mesh fixation with short-term absorbable sutures: A registry study of 82 015 Lichtenstein repairs. Arch Surg. 2011 Jan;146(1):12-7. doi: 10.1001/archsurg.2010.302.
• Olsson A, Sandblom G, Fränneby U, Sondén A, Gunnarsson U, Dahlstrand U. The Short-Form Inguinal Pain Questionnaire (sf-IPQ): An Instrument for Rating Groin Pain After Inguinal Hernia Surgery in Daily Clinical Practice. World J Surg. 2019 Mar;43(3):806-811. doi: 10.1007/s00268-018-4863-8.

• Responsible Party: Bengt Novik, MD, SSOD, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT04839848
• Other Study ID Numbers: Bengan V
• First Posted: Apr 9, 2021
• Last Update Posted: Apr 9, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Bengt Novik, MD, SSOD, Karolinska Institutet: Swedish Hernia Registry; Lichtenstein; Surgical mesh; Surgical sutures
• Additional relevant MeSH terms: Chronic Pain; Pain, Postoperative; Hernia; Hernia, Inguinal; Hernia, Femoral

Study Results

No Results Posted as of Apr 9, 2021