Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study
| Registry | NCT03755219 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 38450 (Actual) |
| Sponsor | Bengt Novik (Other); collaborators: Uppsala University, Swedish Hernia Registry, Skaraborg Hospital Research & Development Center, Sweden |
| Conditions | Hernia, Inguinal, Surgical Mesh, Laparoscopy, Hernia, Hernia, Femoral, Surgical Procedures, Minimally Invasive, Surgical Staplers, Recurrence, Fixation Device; Complications |
| Interventions | TEP, TAPP (Procedure) |
| Dates | start 2005-01-01, primary completion 2017-12-31, completion 2018-12-31, first posted 2018-11-27, last updated 2022-12-01 |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| StdPPM | Procedure: TEP; Procedure: TAPP | Standard pure polypropylene mesh. "Standard" is defined in SHR by weight ≥ 50 g/square meter. | |
| LWM | Procedure: TEP; Procedure: TAPP | 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 | Procedure: TEP; Procedure: TAPP | Metal staples or tacks. Material specification of staples/tacks was introduced in SHR 2012. | |
| Tacks, absorbable | Procedure: TEP; Procedure: TAPP | Absorbable synthetic staples or tacks. Material specification of staples/tacks was introduced in SHR 2012. | |
| Tacks, uncategorized | Procedure: TEP; Procedure: TAPP | 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 | Procedure: TEP; Procedure: TAPP | Biologic glue/sealant produced from human donor blood | |
| Non-fixation | Procedure: TEP; Procedure: TAPP | Mesh is deployed without fixation | |
| 3D Mesh | Procedure: TEP; Procedure: TAPP | 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.. |
Sex: All, ages: 15 Years to any
Inclusion Criteria: * All laparoscopic (mainly TEP and TAPP) repairs that have been registered in the SHR from January 1, 2005 until December 31, 2018. Exclusion Criteria: * 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.