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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03755219
Enrollment
38450
Registered
2018-11-27
Start date
2005-01-01
Completion date
2018-12-31
Last updated
2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fixation Device; Complications, Hernia, Hernia, Femoral, Hernia, Inguinal, Laparoscopy, Recurrence, Surgical Mesh, Surgical Procedures, Minimally Invasive, Surgical Staplers

Keywords

Totally extraperitoneal, Transabdominal preperitoneal, Fibrin glue, Fibrin sealant, Mesh fixation, Fixation devices

Brief 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.

Interventions

PROCEDURETEP

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

PROCEDURETAPP

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

Sponsors

Uppsala University
CollaboratorOTHER
Swedish Hernia Registry
CollaboratorUNKNOWN
Skaraborg Hospital Research & Development Center, Sweden
CollaboratorUNKNOWN
Bengt Novik
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Reoperation for recurrenceAssessment at Dec 31, 2018The date of the recurrent surgery
DeathAssessment at Dec 31, 2018The date of death

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026