Postoperative PainNCT04838028
Chronic Postoperative Pain After Laparoendoscopic Groin Hernia Repair
An observational study of Postoperative Pain and Chronic Pain, run by Karolinska Institutet.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Postoperative Pain, Chronic Pain
- What is being tested?
- TEP, TAPP and Other or unspecified laparoendoscopic groin hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 15,360 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2012to 6 Nov 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: An unselected, consecutive nationwide cohort during 7 years, with a 1-year follow-up.
Who may be able to join
- All laparoendoscopic repairs for groin hernia that have been registered in the SHR from September 1, 2012, until December 31, 2018.
Who cannot join
- 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.
About this study
Official title: 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).
Read the 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.
- Conditions
- Postoperative Pain, Chronic Pain
- Being tested
- TEP, TAPP, Other or unspecified laparoendoscopic groin hernia repair
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEPProcedure or surgery
Laparoendoscopic totally extraperitoneal mesh repair of groin hernia
TAPPProcedure or surgery
Laparoscopic transabdominal mesh repair of groin hernia
Other or unspecified laparoendoscopic groin hernia repairProcedure or surgery
"Other" refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, "intraperitoneal onlay mesh" (IPOM).
| Study group | Role | What they receive |
|---|---|---|
| Standard polypropylene mesh | Density > 50 g/square meter Receives: Procedure: TEP; Procedure: TAPP; Procedure: Other or unspecified laparoendoscopic groin hernia repair | |
| 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". Receives: Procedure: TEP; Procedure: TAPP; Procedure: Other or unspecified laparoendoscopic groin hernia repair | |
| Fixation with metal tacks | Non-absorbable metal staples or tacks Receives: Procedure: TEP; Procedure: TAPP; Procedure: Other or unspecified laparoendoscopic groin hernia repair | |
| Fixation with absorbable tacks | Absorbable synthetic staples or tacks Receives: Procedure: TEP; Procedure: TAPP; Procedure: Other or unspecified laparoendoscopic groin hernia repair | |
| Fibrin glue fixation | Biologic glue/sealant produced from human donor blood Receives: Procedure: TEP; Procedure: TAPP; Procedure: Other or unspecified laparoendoscopic groin hernia repair | |
| Non-fixation | Mesh is deployed without fixation Receives: Procedure: TEP; Procedure: TAPP; Procedure: Other or unspecified laparoendoscopic groin hernia repair | |
| 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. Receives: Procedure: TEP; Procedure: TAPP; Procedure: Other or unspecified laparoendoscopic groin hernia repair | |
| Progrip fixation | Absorbable (Velcro type of) microhooks. The particular meshes come with prefabricated Progrip microhooks. Progrip = Registered trademark. Receives: Procedure: TEP; Procedure: TAPP; Procedure: Other or unspecified laparoendoscopic groin hernia repair | |
| 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". Receives: Procedure: TEP; Procedure: TAPP; Procedure: Other or unspecified laparoendoscopic groin hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative risk for postoperative pain at 1 year
Chronic postoperative inguinal pain, measured by the Short Form Inguinal Pain Questionnaire (sf-IPQ)
Measured: 1 year
Secondary outcomes (1)
Reoperation
Reoperation due to recurrence, during the study period
Measured: 1-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Sep 2012
- Primary completion31 Dec 2019
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,360 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, Swedish Hernia Registry
- Responsible party
- Principal investigator, Bengt Novik, Karolinska Institutet
- Investigators
- Bengt Novik, MD, Principal investigator, Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838028
- Sponsor's protocol ID
- Bengan IV
- Status last verified
- Jun 2025
- First submitted
- 7 Apr 2021
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 21242440Novik 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.
PubMed 16424986Franneby 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.
PubMed 18161900Olsson 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.
PubMed 30478683Novik 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.
PubMed 35213495Novik B, Sandblom G, Thorell A. Preoperative predictors of chronic pain after laparoendoscopic groin hernia repair: A Swedish Hernia Registry study. Hernia. 2025 Oct 18;29(1):303. doi: 10.1007/s10029-025-03428-2.
PubMed 41107627
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh and Fixation Combinations in Laparoendoscopic Groin Hernia Repair: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study.
- ClinicalTrials.gov ID
- NCT04838028
- Acronym / sponsor ID
- Bengan IV
- Conditions
- Postoperative Pain, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,360 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Uppsala University, Swedish Hernia Registry
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Standard polypropylene mesh | – | Procedure: TEP, Procedure: TAPP, Procedure: Other or unspecified laparoendoscopic groin hernia repairDensity > 50 g/square meter |
| Lightweight mesh | – | Procedure: TEP, Procedure: TAPP, Procedure: Other or unspecified laparoendoscopic groin hernia repair* 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 | – | Procedure: TEP, Procedure: TAPP, Procedure: Other or unspecified laparoendoscopic groin hernia repairNon-absorbable metal staples or tacks |
| Fixation with absorbable tacks | – | Procedure: TEP, Procedure: TAPP, Procedure: Other or unspecified laparoendoscopic groin hernia repairAbsorbable synthetic staples or tacks |
| Fibrin glue fixation | – | Procedure: TEP, Procedure: TAPP, Procedure: Other or unspecified laparoendoscopic groin hernia repairBiologic glue/sealant produced from human donor blood |
| Non-fixation | – | Procedure: TEP, Procedure: TAPP, Procedure: Other or unspecified laparoendoscopic groin hernia repairMesh is deployed without fixation |
| 3D mesh | – | Procedure: TEP, Procedure: TAPP, Procedure: Other or unspecified laparoendoscopic groin hernia repairA 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 | – | Procedure: TEP, Procedure: TAPP, Procedure: Other or unspecified laparoendoscopic groin hernia repairAbsorbable (Velcro type of) microhooks. The particular meshes come with prefabricated Progrip microhooks. Progrip = Registered trademark. |
| Polyester mesh | – | Procedure: TEP, Procedure: TAPP, Procedure: Other or unspecified laparoendoscopic groin hernia repairPolyester-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". |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- An unselected, consecutive nationwide cohort during 7 years, with a 1-year follow-up.
Key inclusion criteria (1 listed)
- All laparoendoscopic repairs for groin hernia that have been registered in the SHR from September 1, 2012, until December 31, 2018.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEPLaparoendoscopic totally extraperitoneal mesh repair of groin hernia | Procedure or surgery | 3D mesh, Fibrin glue fixation, Fixation with absorbable tacks, Fixation with metal tacks, Lightweight mesh, Non-fixation, Polyester mesh, Progrip fixation, Standard polypropylene mesh |
| TAPPLaparoscopic transabdominal mesh repair of groin hernia | Procedure or surgery | 3D mesh, Fibrin glue fixation, Fixation with absorbable tacks, Fixation with metal tacks, Lightweight mesh, Non-fixation, Polyester mesh, Progrip fixation, Standard polypropylene mesh |
| 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). | Procedure or surgery | 3D mesh, Fibrin glue fixation, Fixation with absorbable tacks, Fixation with metal tacks, Lightweight mesh, Non-fixation, Polyester mesh, Progrip fixation, Standard polypropylene mesh |
Primary outcome
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 secondary outcome
Reoperation
Time frame: 1-8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Background: PubMed 21242440Novik 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.
- Background: PubMed 16424986Novik 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.
- Background: PubMed 18161900Franneby 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.
- Background: PubMed 30478683Olsson 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.
- Background: PubMed 35213495Novik 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.
- Derived from this study: PubMed 41107627Novik B, Sandblom G, Thorell A. Preoperative predictors of chronic pain after laparoendoscopic groin hernia repair: A Swedish Hernia Registry study. Hernia. 2025 Oct 18;29(1):303. doi: 10.1007/s10029-025-03428-2.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bengt Novik, MD principal investigator
Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Chronic Pain, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative risk for postoperative pain at 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04838028, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.