Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty

• ClinicalTrials.gov Identifier: NCT04839848
• Recruitment Status: Completed
• First Posted: April 9, 2021
• Last Update Posted: April 9, 2021
• Sponsor: Karolinska Institutet
• Collaborators: Uppsala University; Swedish Hernia Registry
• Information provided by (Responsible Party): Bengt Novik, Karolinska Institutet

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
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
• Target Follow-Up Duration: 1 Year
• 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: September 1, 2012
• Actual Primary Completion Date: November 6, 2019
• Actual Study Completion Date: November 6, 2020

Groups and Cohorts

Group/Cohort	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 [ Time Frame: 1 year ]
   Chronic postoperative inguinal pain

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

An unselected, consecutive nationwide cohort during 7 years, with a 1-year follow-up

Criteria

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

No Contacts or Locations Provided

More Information

Publications:

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.

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.

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.

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: April 9, 2021
• Last Update Posted: April 9, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• 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, Karolinska Institutet:

Swedish Hernia Registry; Lichtenstein; Surgical mesh; Surgical sutures

Additional relevant MeSH terms:

Pain, Postoperative; Chronic Pain; Hernia; Hernia, Inguinal; Hernia, Femoral; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal