Hernia, InguinalNCT04839848
Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty
An observational study of Hernia, Inguinal and Hernia, Femoral, run by Karolinska Institutet.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Hernia, Inguinal, Hernia, Femoral, Postoperative Pain
- What is being tested?
- Lichtenstein mesh repair
- Type of treatment
- Medical device
- How many people
- 80,733 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 Lichtenstein and similar open mesh repairs that have been registered in the SHR from September 1, 2012, until December 31, 2018.
Who cannot join
- Laparoscopic repairs.
- Preperitoneal open repairs.
- Pure suture repairs
- Patients not having a 10-digit state-assigned Patient Identification Number.
About this study
Official title: Mesh and Fixation Combinations in the Lichtenstein Groin Hernioplasty: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study.
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).
Read the 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.
- Conditions
- Hernia, Inguinal, Hernia, Femoral, Postoperative Pain, Chronic Pain, PROM, Suture Related Complication
- Being tested
- Lichtenstein mesh repair
- Keywords
- Swedish Hernia Registry, Lichtenstein, Surgical mesh, Surgical sutures
- Medical subject headings
- Hernia, Inguinal, Hernia, Femoral, Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein mesh repairDevice
A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures
| Study group | Role | What they receive |
|---|---|---|
| Permanent suture | Mesh fixation with permanent suture Receives: Device: Lichtenstein mesh repair | |
| Long-term absorbable | Mesh fixation with long-term absorbable suture Receives: Device: Lichtenstein mesh repair | |
| Short-term absorbable | Mesh fixation with short-term absorbable suture Receives: Device: Lichtenstein mesh repair | |
| Fibrin glue | Biologic glue/sealant produced from human donor blood Receives: Device: Lichtenstein mesh repair | |
| Progrip | Pre-fabricated absorbable fixation hooks, integrated in mesh. Progrip is a registered trademark owned by Medtronic Receives: Device: Lichtenstein mesh repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPIP
Chronic postoperative inguinal pain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Sep 2012
- Primary completion6 Nov 2019
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies 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
- 80,733 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839848
- Sponsor's protocol ID
- Bengan V
- Status last verified
- Nov 2022
- First submitted
- 7 Apr 2021
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35213495
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh and Fixation Combinations in the Lichtenstein Groin Hernioplasty: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study.
- ClinicalTrials.gov ID
- NCT04839848
- Acronym / sponsor ID
- Bengan V
- Conditions
- Hernia, Inguinal, Hernia, Femoral, Postoperative Pain, Chronic Pain, PROM, Suture Related Complication
- Keywords
- Swedish Hernia Registry, Lichtenstein, Surgical mesh, Surgical sutures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80,733 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Uppsala University, Swedish Hernia Registry
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 9 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) 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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Permanent suture | – | Device: Lichtenstein mesh repairMesh fixation with permanent suture |
| Long-term absorbable | – | Device: Lichtenstein mesh repairMesh fixation with long-term absorbable suture |
| Short-term absorbable | – | Device: Lichtenstein mesh repairMesh fixation with short-term absorbable suture |
| Fibrin glue | – | Device: Lichtenstein mesh repairBiologic glue/sealant produced from human donor blood |
| Progrip | – | Device: Lichtenstein mesh repairPre-fabricated absorbable fixation hooks, integrated in mesh. Progrip is a registered trademark owned by Medtronic |
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 Lichtenstein and similar open mesh repairs that have been registered in the SHR from September 1, 2012, until December 31, 2018.
Key exclusion criteria (4 listed)
- Laparoscopic repairs.
- Preperitoneal open repairs.
- Pure suture repairs
- Patients not having a 10-digit state-assigned Patient Identification Number.
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 |
|---|---|---|
| Lichtenstein mesh repairA groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures | Device | Fibrin glue, Long-term absorbable, Permanent suture, Progrip, Short-term absorbable |
Primary outcome
CPIP
Time frame: 1 year
Chronic postoperative inguinal pain
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 5 Dec 2022.
- 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Inguinal and Hernia, Femoral, 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 4 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 5 Dec 2022. 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?
CPIP (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 NCT04839848, which also lists 5 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 5 Dec 2022.