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OpenTrials
Completed

NCT Number: NCT02561910

Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results

The effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one year period a total of 1208 inguinal hernias in 952 patients were consecutively operated using the laparoscopic technique by a total of 11 general surgeons in daily clinical routine.

Laparoscopic hernia repair in the TAPP technique seems to have the potential to become the standard procedure in inguinal hernia repair in future.

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Key information

Conditions

Unilateral Inguinal Hernia With Gangrene and Obstruction Bites and Stings Chemically-Induced Disorders Poisoning Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hernia Center

Rottenburg, 72108, Germany

About this study

Objective:

Hernia repair is the most frequent operation in general surgery worldwide, but about 25 years after the advent of minimal invasive surgical techniques the effectiveness of laparoscopic inguinal hernia repair still remains unclear.

Methods:

All patients admitted to the hospital for surgery of an inguinal hernia during a one year period were prospectively documented and included in a follow-up study. The follow-up was performed at least 5 years after surgery and consisted of a clinical examination, ultrasound investigation and a questionnaire.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All patients fit for general anesthesia and presenting an inguinal hernia.

Exclusion criteria

  • Not fit for general anesthesia, young age (>21 years), not wanting a mesh.

Treatment and study plan

Laparoscopic hernia repair

Device

Preperitoneal mesh implantation because of inguinal hernia disease using the laparoscopic technique

Primary outcomes

  1. The primary outcome of the trial was recurrence of a hernia within five years after the repair.

    Time frame: 5 years

Secondary outcomes

  1. The secondary outcome was chronic pain.

    Time frame: 5 years

    Chronic pain was measured by VAS scale

Sponsors and collaborators

Lead sponsor

Hernia Center Rottenburg

Other

Registry information

Important dates

Study start
2000
Primary completion
2008
Study completion
2015
First posted
Sep 28, 2015
Registry last updated
Sep 28, 2015

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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