Recurrence and Patient Satisfaction After Laparoscopic Hernia Repair With Intraperitoneal Onlay-mesh (IPOM)
SGChirIPOM
1 other identifier
observational
348
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFebruary 19, 2014
February 1, 2014
3 months
April 23, 2013
February 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence rate
Hernia recurrence at the time of phone survey (2 - 7 years after surgery)
7 years
Secondary Outcomes (2)
Time to recurrence
7 years
Patient satisfaction
2 - 7 years after surgery
Study Arms (3)
no gap closure
no hernia gap closure
extracorporal gap closure
extracorporal hernia gap closure extracorporal suturing of gap
intracorporal gap closure
intracorporal hernia gap closure
Interventions
type of gap closure during laparoscopic repair of a ventral hernia: none, extracorporal, intracorporal
ventral hernia gap is sutured extracorporally
Eligibility Criteria
Patients after laparoscopic repair of a ventral hernia (including recurrent hernias)
You may qualify if:
- hernia repair between 2006 and 2011
- laparoscopic hernia repair using intraperitoneal onlay-mesh (IPOM)
- patient agrees to be surveyed by phone
You may not qualify if:
- Patient rejects participation in survey
- patient already rejected use of his/her data for research purposes at admittance to surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cantonal Hospital St.Gallen
Sankt Gallen, 9007, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sascha Müller, MD
Cantonal Hospital of St. Gallen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
April 23, 2013
First Posted
April 25, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
February 19, 2014
Record last verified: 2014-02