Recurrence and Patient Satisfaction After Laparoscopic Hernia Repair With Intraperitoneal Onlay-mesh (IPOM) (SGChirIPOM)

February 17, 2014 updated by: Sascha Müller, Cantonal Hospital of St. Gallen

For laparoscopic ventral hernia repair, the technique to close the hernia gap is not well established. Mainly three techniques are currently applied:

  • no closure at all
  • extracorporal suturing of the gap
  • intracorporal suturing of the gap

All three techniques have been applied at our hospital. Patients who received laparoscopic hernia repair between 2006 and 2011 will be identified from the patient database and will be contacted by phone to inquire about the outcome and the satisfaction of the surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

348

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

  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Cantonal Hospital St.Gallen

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients after laparoscopic repair of a ventral hernia (including recurrent hernias)

Description

Inclusion Criteria:

  • hernia repair between 2006 and 2011
  • laparoscopic hernia repair using intraperitoneal onlay-mesh (IPOM)
  • patient agrees to be surveyed by phone

Exclusion Criteria:

  • Patient rejects participation in survey
  • patient already rejected use of his/her data for research purposes at admittance to surgery

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
no gap closure
no hernia gap closure
extracorporal gap closure

extracorporal hernia gap closure

extracorporal suturing of gap
Procedure: hernia gap closure
type of gap closure during laparoscopic repair of a ventral hernia: none, extracorporal, intracorporal
Procedure: extracorporal suturing of gap
ventral hernia gap is sutured extracorporally
intracorporal gap closure
intracorporal hernia gap closure
Procedure: hernia gap closure
type of gap closure during laparoscopic repair of a ventral hernia: none, extracorporal, intracorporal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: 7 years
Hernia recurrence at the time of phone survey (2 - 7 years after surgery)
7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recurrence
Time Frame: 7 years
time from surgery to hernia recurrence
7 years
Patient satisfaction
Time Frame: 2 - 7 years after surgery
questionnaire with 4 items and 5 step Likert scales
2 - 7 years after surgery

Collaborators and Investigators

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

Sponsor

Cantonal Hospital of St. Gallen

Investigators

  • Principal Investigator: Sascha Müller, MD, Cantonal Hospital St. Gallen

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

May 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 17, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGChirIPOM

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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