Recurrence and Patient Satisfaction After Laparoscopic He... | NCT01839942

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

NCT01839942

Sponsor

Cantonal Hospital of St. Gallen

Status

Completed

Last Update Posted

Feb 19, 2014Estimated

Enrollment

348Actual

Phase

Not provided

Conditions

Ventral Hernia
Recurrent Ventral Hernia

Interventions

hernia gap closure
extracorporal suturing of gap

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Apr 23, 2013

First Submission Date that Met QC Criteria

Apr 23, 2013

First Posted Date

Apr 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2014

Last Update Posted Date

Feb 19, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sascha Müller, Attending physician, Cantonal Hospital of St. GallenPrincipal Investigator

Lead Sponsor

Cantonal Hospital of St. GallenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

348Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
no gap closure	no hernia gap closure
extracorporal gap closure	extracorporal hernia gap closure extracorporal suturing of gap	Procedure: hernia gap closure Procedure: extracorporal suturing of gap
intracorporal gap closure	intracorporal hernia gap closure	Procedure: hernia gap closure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hernia gap closure	Procedure	type of gap closure during laparoscopic repair of a ventral hernia: none, extracorporal, intracorporal	extracorporal gap closure intracorporal gap closure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sascha Müller, MD	Cantonal Hospital of St. Gallen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cantonal Hospital St.Gallen		Sankt Gallen		9007	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D006555	Hernia, Ventral

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided