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OpenTrials
Completed

NCT Number: NCT03755219

Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery

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).

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Key information

Conditions

Hernia, Inguinal Disease Attributes Fixation Device; Complications Hernia Hernia, Abdominal Hernia, Femoral Laparoscopy Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Recurrence Surgical Mesh Surgical Procedures, Minimally Invasive Surgical Staplers

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Laparoscopic totally extraperitoneal mesh repair

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

Other names: Laparoscopic transabdominal preperitoneal mesh repair

Primary outcomes

  1. Reoperation for recurrence

    Time frame: Assessment at Dec 31, 2018

    The date of the recurrent surgery

  2. Death

    Time frame: Assessment at Dec 31, 2018

    The date of death

Sponsors and collaborators

Lead sponsor

Bengt Novik

Other

Collaborators

  • Skaraborg Hospital Research & Development Center, Sweden
  • Swedish Hernia Registry
  • Uppsala University

Registry information

Official study title

Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study

Important dates

Study start
2005
Primary completion
2017
Study completion
2018
First posted
Nov 27, 2018
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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