Chronic Postoperative Pain After Laparoendoscopic Groin Hernia Repair
June 26, 2025 updated by: Bengt Novik, Karolinska Institutet
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
Intervention / Treatment
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-fixation
Mesh is deployed without fixation
|
Laparoscopic transabdominal mesh repair of groin hernia
Laparoendoscopic totally extraperitoneal 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).
|
|
Standard polypropylene mesh
Density > 50 g/square meter
|
Laparoscopic transabdominal mesh repair of groin hernia
Laparoendoscopic totally extraperitoneal 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).
|
|
Fixation with metal tacks
Non-absorbable metal staples or tacks
|
Laparoscopic transabdominal mesh repair of groin hernia
Laparoendoscopic totally extraperitoneal 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).
|
|
Fixation with absorbable tacks
Absorbable synthetic staples or tacks
|
Laparoscopic transabdominal mesh repair of groin hernia
Laparoendoscopic totally extraperitoneal 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).
|
|
Fibrin glue fixation
Biologic glue/sealant produced from human donor blood
|
Laparoscopic transabdominal mesh repair of groin hernia
Laparoendoscopic totally extraperitoneal 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).
|
|
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. |
Laparoscopic transabdominal mesh repair of groin hernia
Laparoendoscopic totally extraperitoneal 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).
|
|
Progrip fixation
Absorbable (Velcro type of) microhooks.
The particular meshes come with prefabricated Progrip microhooks.
Progrip = Registered trademark.
|
Laparoscopic transabdominal mesh repair of groin hernia
Laparoendoscopic totally extraperitoneal 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).
|
|
Lightweight mesh
|
Laparoscopic transabdominal mesh repair of groin hernia
Laparoendoscopic totally extraperitoneal 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).
|
|
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".
|
Laparoscopic transabdominal mesh repair of groin hernia
Laparoendoscopic totally extraperitoneal 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative risk for postoperative pain at 1 year
Time Frame: 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
Time Frame: 1-8 years
|
Reoperation due to recurrence, during the study period
|
1-8 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bengt Novik, MD, Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
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