Hernia, InguinalNCT03755219
Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery
An observational study of Hernia, Inguinal and Surgical Mesh, run by Bengt Novik.
Trial summary
The study attempts to quantify the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type. 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, Surgical Mesh, Laparoscopy
- What is being tested?
- TEP and TAPP
- Type of treatment
- Surgery or procedure
- How many people
- 38,450 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 31 Dec 2018
- How long will I take part?
- 14 Years
- 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: The study population consists of all laparoscopic TEP and TAPP repairs that have been registered in the SHR from September 1, 2005 until December 31, 2017. The database is the SHR, which was launched in 1992 and prospectively records groin (lateral, medial and femoral) hernia repairs, including both public and private hospitals. The source population are all residents in Sweden from the age of 15 years, having a state-assigned personal identity number.
Who may be able to join
- All laparoscopic (mainly TEP and TAPP) repairs that have been registered in the SHR from January 1, 2005 until December 31, 2018.
Who cannot join
- Open repairs.
- Hernioplasties that were converted from laparoscopic to open surgery.
- Age < 15 years.
- Patients not having a 10-digit state-assigned Patient Identification Number.
About this study
Official title: Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study
The study attempts to quantify the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type.
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 more than 38,000 TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enables assessment of the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type, with fulfilling statistical power.
Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. Reoperations were registered in the SHR in the same manner as index repairs, and were used as endpoints.
- Conditions
- Hernia, Inguinal, Surgical Mesh, Laparoscopy, Hernia, Hernia, Femoral, Surgical Procedures, Minimally Invasive
- Being tested
- TEP, TAPP
- Keywords
- Totally extraperitoneal, Transabdominal preperitoneal, Fibrin glue, Fibrin sealant, Mesh fixation, Fixation devices
- Medical subject headings
- Hernia, Inguinal, Hernia, Hernia, Femoral, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEPProcedure or surgery
Also called Laparoscopic totally extraperitoneal mesh repair
By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device
TAPPProcedure or surgery
Also called Laparoscopic transabdominal preperitoneal mesh repair
By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device
| Study group | Role | What they receive |
|---|---|---|
| StdPPM | Standard pure polypropylene mesh.
"Standard" is defined in SHR by weight ≥ 50 g/square meter. Receives: Procedure: TEP; Procedure: TAPP | |
| LWM | Lightweight mesh: Either a pure polypropylene mesh, or a polypropylene-based composite mesh.
The study uses SHR's classification of "light-weight" = <50 g/square meter. Receives: Procedure: TEP; Procedure: TAPP | |
| Tacks, metal | Metal staples or tacks. Material specification of staples/tacks was introduced in SHR 2012. Receives: Procedure: TEP; Procedure: TAPP | |
| Tacks, absorbable | Absorbable synthetic staples or tacks. Material specification of staples/tacks was introduced in SHR 2012. Receives: Procedure: TEP; Procedure: TAPP | |
| Tacks, uncategorized | Staples or tacks were in SHR 2005-2011 not further categorized.
This category also includes staples/tacks registered from 2012 and forth, not being specified as either metal or absorbable. Receives: Procedure: TEP; Procedure: TAPP | |
| Fibrin glue | Biologic glue/sealant produced from human donor blood Receives: Procedure: TEP; Procedure: TAPP | |
| Non-fixation | Mesh is deployed without fixation Receives: Procedure: TEP; Procedure: TAPP | |
| 3D Mesh | Mesh categorized by anatomical shaped, rather than material or weight. Therefore, this category will be excluded in the original study. Depending on the volume of casess found, the 3D mesh category may eventually be analyzed separately in another study.. Receives: Procedure: TEP; Procedure: TAPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation for recurrence
The date of the recurrent surgery
Measured: Assessment at Dec 31, 2018
Death
The date of death
Measured: Assessment at Dec 31, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Jan 2005
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- 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
- 38,450 participants (actual)
- Target duration
- 14 Years
Sponsor and investigators
- Lead sponsor
- Bengt Novik
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, Swedish Hernia Registry, Skaraborg Hospital Research & Development Center, Sweden
- Responsible party
- Sponsor-investigator, Bengt Novik, Karolinska Institutet
- Investigators
- Bengt Novik, Principal investigator, Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755219
- Sponsor's protocol ID
- Bengan III
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2018
- Last updated
- 1 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 16424986Novik B, et al. Mesh and mesh fixation in laparoscopic groin hernia repairs. A study of 25,189 TEP and TAPP in the Swedish Hernia Registry [congress abstract]. Hernia 2019; 23 (Suppl 2):S251-S252. https://doi.org/10.1007/s10029-019-02013-8
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.
PubMed 35213495
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study
- ClinicalTrials.gov ID
- NCT03755219
- Acronym / sponsor ID
- Bengan III
- Conditions
- Hernia, Inguinal, Surgical Mesh, Laparoscopy, Hernia, Hernia, Femoral, Surgical Procedures, Minimally Invasive
- Keywords
- Totally extraperitoneal, Transabdominal preperitoneal, Fibrin glue, Fibrin sealant, Mesh fixation, Fixation devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38,450 participants (actual)
- Lead sponsor
- Bengt NovikUniversity, hospital or other
- Collaborators
- Uppsala University, Swedish Hernia Registry, Skaraborg Hospital Research & Development Center, Sweden
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Nov 2018 (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 recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type.
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 more than 38,000 TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enables assessment of the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type, with fulfilling statistical power.
Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. Reoperations were registered in the SHR in the same manner as index repairs, and were used as endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Years
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| StdPPM | – | Procedure: TEP, Procedure: TAPPStandard pure polypropylene mesh. "Standard" is defined in SHR by weight ≥ 50 g/square meter. |
| LWM | – | Procedure: TEP, Procedure: TAPPLightweight mesh: Either a pure polypropylene mesh, or a polypropylene-based composite mesh. The study uses SHR's classification of "light-weight" = <50 g/square meter. |
| Tacks, metal | – | Procedure: TEP, Procedure: TAPPMetal staples or tacks. Material specification of staples/tacks was introduced in SHR 2012. |
| Tacks, absorbable | – | Procedure: TEP, Procedure: TAPPAbsorbable synthetic staples or tacks. Material specification of staples/tacks was introduced in SHR 2012. |
| Tacks, uncategorized | – | Procedure: TEP, Procedure: TAPPStaples or tacks were in SHR 2005-2011 not further categorized. This category also includes staples/tacks registered from 2012 and forth, not being specified as either metal or absorbable. |
| Fibrin glue | – | Procedure: TEP, Procedure: TAPPBiologic glue/sealant produced from human donor blood |
| Non-fixation | – | Procedure: TEP, Procedure: TAPPMesh is deployed without fixation |
| 3D Mesh | – | Procedure: TEP, Procedure: TAPPMesh categorized by anatomical shaped, rather than material or weight. Therefore, this category will be excluded in the original study. Depending on the volume of casess found, the 3D mesh category may eventually be analyzed separately in another study.. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of all laparoscopic TEP and TAPP repairs that have been registered in the SHR from September 1, 2005 until December 31, 2017. The database is the SHR, which was launched in 1992 and prospectively records groin (lateral, medial and femoral) hernia repairs, including both public and private hospitals. The source population are all residents in Sweden from the age of 15 years, having a state-assigned personal identity number.
Key inclusion criteria (1 listed)
- All laparoscopic (mainly TEP and TAPP) repairs that have been registered in the SHR from January 1, 2005 until December 31, 2018.
Key exclusion criteria (4 listed)
- Open repairs.
- Hernioplasties that were converted from laparoscopic to open surgery.
- Age < 15 years.
- 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 |
|---|---|---|
| TEPAlso: Laparoscopic totally extraperitoneal mesh repairBy laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device | Procedure or surgery | 3D Mesh, Fibrin glue, LWM, Non-fixation, StdPPM, Tacks, absorbable, Tacks, metal, Tacks, uncategorized |
| TAPPAlso: Laparoscopic transabdominal preperitoneal mesh repairBy laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device | Procedure or surgery | 3D Mesh, Fibrin glue, LWM, Non-fixation, StdPPM, Tacks, absorbable, Tacks, metal, Tacks, uncategorized |
Primary outcome
Reoperation for recurrence
Time frame: Assessment at Dec 31, 2018
The date of the recurrent surgery
Death
Time frame: Assessment at Dec 31, 2018
The date of death
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 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.
- Results publicationNovik B, et al. Mesh and mesh fixation in laparoscopic groin hernia repairs. A study of 25,189 TEP and TAPP in the Swedish Hernia Registry [congress abstract]. Hernia 2019; 23 (Suppl 2):S251-S252. https://doi.org/10.1007/s10029-019-02013-8
- Results publication: 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.
Bengt Novik 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 Hernia, Inguinal and Surgical Mesh, run by Bengt Novik.
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 1 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?
Reoperation for recurrence (time frame: Assessment at Dec 31, 2018). The study lists 2 primary outcomes in all. 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 NCT03755219, which also lists 4 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 Dec 2022.