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| Name | Class |
|---|---|
| Uppsala University | OTHER |
| Swedish Hernia Registry | UNKNOWN |
| Skaraborg Hospital Research & Development Center, Sweden | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StdPPM | Standard pure polypropylene mesh. "Standard" is defined in SHR by weight ≥ 50 g/square meter. |
| |
| 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. |
| |
| Tacks, metal | Metal staples or tacks. Material specification of staples/tacks was introduced in SHR 2012. |
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| Tacks, absorbable | Absorbable synthetic staples or tacks. Material specification of staples/tacks was introduced in SHR 2012. |
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| 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. |
| |
| Fibrin glue |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEP | Procedure | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation for recurrence | The date of the recurrent surgery | Assessment at Dec 31, 2018 |
| Death | The date of death | Assessment at Dec 31, 2018 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bengt Novik | Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21242440 | Background | 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. | |
| 16424986 | Background | 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. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D006547 | Hernia |
| D006550 | Hernia, Femoral |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| C072829 | tetraethylpyrazine |
| C034807 | tetra-4-amidinophenoxypropane |
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Biologic glue/sealant produced from human donor blood |
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| Non-fixation | Mesh is deployed without fixation |
|
| 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.. |
|
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| TAPP | Procedure | 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 |
|
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| Result | Novik 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 |
| 35213495 | Result | 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. |
| D010335 | Pathologic Processes |