Trials / Completed
CompletedNCT03755219
Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery
Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 38,450 (actual)
- Sponsor
- Bengt Novik · Academic / Other
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
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).
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
- Surgical Staplers
- Recurrence
- Fixation Device; Complications
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | TEP | 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 |
| PROCEDURE | TAPP | 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 |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2017-12-31
- Completion
- 2018-12-31
- First posted
- 2018-11-27
- Last updated
- 2022-12-01
Source: ClinicalTrials.gov record NCT03755219. Inclusion in this directory is not an endorsement.