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

Ventral Hernia Clinical Trial

— SGChirIPOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839942
• Other study ID #: SGChirIPOM
• Status: Completed
• Phase: N/A
• First received: April 23, 2013
• Last updated: February 17, 2014
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Recurrent Ventral Hernia
• Ventral Hernia

Intervention

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

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital St.Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate	Hernia recurrence at the time of phone survey (2 - 7 years after surgery)	7 years	No
Secondary	Time to recurrence	time from surgery to hernia recurrence	7 years	No
Secondary	Patient satisfaction	questionnaire with 4 items and 5 step Likert scales	2 - 7 years after surgery	No