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

September 25, 2015 updated by: Prof.Dr. Reinhard Bittner, Hernia Center Rottenburg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

952

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Rottenburg, Germany, 72108
        • Hernia Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted for hernia surgery during a one year period (n=928) were operated exclusively in TAPP technique and were assigned to follow-up.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome of the trial was recurrence of a hernia within five years after the repair.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcome was chronic pain.
Time Frame: 5 years
Chronic pain was measured by VAS scale
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hernia Center Rottenburg

Investigators

  • Principal Investigator: Reinhard Bittner, M.D., Hernia Center Rottenburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 25, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 28, 2015

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 25, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HerniaCR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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