Chronic Postoperative Pain After Laparoendoscopic Groin Hernia Repair

Mesh and Fixation Combinations in Laparoendoscopic Groin Hernia Repair: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study.

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).

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Postoperative Pain
• Intervention / Treatment: Procedure: TAPP; Procedure: TEP; Procedure: Other or unspecified laparoendoscopic groin hernia repair

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.

• Study Type: Observational
• Enrollment (Actual): 15360

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-fixation; Mesh is deployed without fixation	Procedure: TAPP; Laparoscopic transabdominal mesh repair of groin hernia; Procedure: TEP; Laparoendoscopic totally extraperitoneal mesh repair of groin hernia; Procedure: Other or unspecified laparoendoscopic groin hernia repair; "Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Standard polypropylene mesh; Density > 50 g/square meter	Procedure: TAPP; Laparoscopic transabdominal mesh repair of groin hernia; Procedure: TEP; Laparoendoscopic totally extraperitoneal mesh repair of groin hernia; Procedure: Other or unspecified laparoendoscopic groin hernia repair; "Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Fixation with metal tacks; Non-absorbable metal staples or tacks	Procedure: TAPP; Laparoscopic transabdominal mesh repair of groin hernia; Procedure: TEP; Laparoendoscopic totally extraperitoneal mesh repair of groin hernia; Procedure: Other or unspecified laparoendoscopic groin hernia repair; "Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Fixation with absorbable tacks; Absorbable synthetic staples or tacks	Procedure: TAPP; Laparoscopic transabdominal mesh repair of groin hernia; Procedure: TEP; Laparoendoscopic totally extraperitoneal mesh repair of groin hernia; Procedure: Other or unspecified laparoendoscopic groin hernia repair; "Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Fibrin glue fixation; Biologic glue/sealant produced from human donor blood	Procedure: TAPP; Laparoscopic transabdominal mesh repair of groin hernia; Procedure: TEP; Laparoendoscopic totally extraperitoneal mesh repair of groin hernia; Procedure: Other or unspecified laparoendoscopic groin hernia repair; "Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
3D mesh; 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.	Procedure: TAPP; Laparoscopic transabdominal mesh repair of groin hernia; Procedure: TEP; Laparoendoscopic totally extraperitoneal mesh repair of groin hernia; Procedure: Other or unspecified laparoendoscopic groin hernia repair; "Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Progrip fixation; Absorbable (Velcro type of) microhooks. The particular meshes come with prefabricated Progrip microhooks. Progrip = Registered trademark.	Procedure: TAPP; Laparoscopic transabdominal mesh repair of groin hernia; Procedure: TEP; Laparoendoscopic totally extraperitoneal mesh repair of groin hernia; Procedure: Other or unspecified laparoendoscopic groin hernia repair; "Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Lightweight mesh; 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".	Procedure: TAPP; Laparoscopic transabdominal mesh repair of groin hernia; Procedure: TEP; Laparoendoscopic totally extraperitoneal mesh repair of groin hernia; Procedure: Other or unspecified laparoendoscopic groin hernia repair; "Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Polyester mesh; 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".	Procedure: TAPP; Laparoscopic transabdominal mesh repair of groin hernia; Procedure: TEP; Laparoendoscopic totally extraperitoneal mesh repair of groin hernia; Procedure: Other or unspecified laparoendoscopic groin hernia repair; "Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative risk for postoperative pain at 1 year	Chronic postoperative inguinal pain, measured by the Short Form Inguinal Pain Questionnaire (sf-IPQ)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation	Reoperation due to recurrence, during the study period	1-8 years

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Uppsala University; Swedish Hernia Registry
• Investigators: Principal Investigator: Bengt Novik, MD, Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm

Publications and helpful links

General Publications

• Franneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyren 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. doi: 10.1002/bjs.6014.
• Novik B, Sandblom G, Ansorge C, Thorell A. Association of Mesh and Fixation Options with Reoperation Risk after Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study of 25,190 Totally Extraperitoneal and Transabdominal Preperitoneal Repairs. J Am Coll Surg. 2022 Mar 1;234(3):311-325. doi: 10.1097/XCS.0000000000000060.
• Novik B, Nordin P, Skullman S, Dalenback 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, Franneby U, Sonden 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.
• Novik B, Hagedorn S, Mork UB, Dahlin K, Skullman S, Dalenback 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. doi: 10.1007/s00464-005-0391-3. Epub 2006 Jan 19.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): November 6, 2020

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Hernia, Abdominal; Pain, Postoperative; Chronic Pain; Hernia; Hernia, Inguinal
• Other Study ID Numbers: Bengan IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The dataset analyzed in the current study was retrieved from the Swedish Hernia Registry. It is not publicly available and cannot be requested from the authors.

To access the data, a separate application must be made to the Registry.

Drug and device information, study documents

• 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