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.
1 other identifier
observational
15,360
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2020
CompletedFirst Submitted
Initial submission to the registry
April 7, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedJuly 1, 2025
June 1, 2025
7.3 years
April 7, 2021
June 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Reoperation
1-8 years
Study Arms (9)
Standard polypropylene mesh
Density \> 50 g/square meter
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".
Fixation with metal tacks
Non-absorbable metal staples or tacks
Fixation with absorbable tacks
Absorbable synthetic staples or tacks
Fibrin glue fixation
Biologic glue/sealant produced from human donor blood
Non-fixation
Mesh is deployed without fixation
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.
Progrip fixation
Absorbable (Velcro type of) microhooks. The particular meshes come with prefabricated Progrip microhooks. Progrip = Registered trademark.
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".
Interventions
Laparoendoscopic totally extraperitoneal mesh repair of groin hernia
Laparoscopic transabdominal mesh repair of groin hernia
"Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
Eligibility Criteria
An unselected, consecutive nationwide cohort during 7 years, with a 1-year follow-up.
You may qualify if:
- All laparoendoscopic repairs for groin hernia that have been registered in the SHR from September 1, 2012, until December 31, 2018.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Uppsala Universitycollaborator
- Swedish Hernia Registrycollaborator
Related Publications (5)
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.
PMID: 21242440BACKGROUNDNovik 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.
PMID: 16424986BACKGROUNDFranneby 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.
PMID: 18161900BACKGROUNDOlsson 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.
PMID: 30478683BACKGROUNDNovik 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.
PMID: 35213495BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bengt Novik, MD
Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, SSOD
Study Record Dates
First Submitted
April 7, 2021
First Posted
April 8, 2021
Study Start
September 1, 2012
Primary Completion
December 31, 2019
Study Completion
November 6, 2020
Last Updated
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
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.