Ventral HerniaSGChirIPOMNCT01839942
Recurrence and Patient Satisfaction After Laparoscopic Hernia Repair With Intraperitoneal Onlay-mesh (IPOM)
An observational study of Ventral Hernia and Recurrent Ventral Hernia, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia, Recurrent Ventral Hernia
- What is being tested?
- hernia gap closure and extracorporal suturing of gap
- Type of treatment
- Surgery or procedure
- How many people
- 348 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after laparoscopic repair of a ventral hernia (including recurrent hernias)
Who may be able to join
- hernia repair between 2006 and 2011
- laparoscopic hernia repair using intraperitoneal onlay-mesh (IPOM)
- patient agrees to be surveyed by phone
Who cannot join
- Patient rejects participation in survey
- patient already rejected use of his/her data for research purposes at admittance to surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Ventral Hernia, Recurrent Ventral Hernia
- Being tested
- hernia gap closure, extracorporal suturing of gap
- Keywords
- Hernia, Ventral
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hernia gap closureProcedure or surgery
type of gap closure during laparoscopic repair of a ventral hernia: none, extracorporal, intracorporal
extracorporal suturing of gapProcedure or surgery
ventral hernia gap is sutured extracorporally
| Study group | Role | What they receive |
|---|---|---|
| no gap closure | no hernia gap closure | |
| extracorporal gap closure | extracorporal hernia gap closure
extracorporal suturing of gap Receives: Procedure: hernia gap closure; Procedure: extracorporal suturing of gap | |
| intracorporal gap closure | intracorporal hernia gap closure Receives: Procedure: hernia gap closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Hernia recurrence at the time of phone survey (2 - 7 years after surgery)
Measured: 7 years
Secondary outcomes (2)
Time to recurrence
time from surgery to hernia recurrence
Measured: 7 years
Patient satisfaction
questionnaire with 4 items and 5 step Likert scales
Measured: 2 - 7 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sascha Müller, Cantonal Hospital of St. Gallen
- Investigators
- Sascha Müller, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839942
- Sponsor's protocol ID
- SGChirIPOM
- Acronym
- SGChirIPOM
- Status last verified
- Feb 2014
- First submitted
- 23 Apr 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence and Patient Satisfaction After Laparoscopic Hernia Repair With Intraperitoneal Onlay-mesh (IPOM)
- ClinicalTrials.gov ID
- NCT01839942
- Acronym / sponsor ID
- SGChirIPOM / SGChirIPOM
- Conditions
- Ventral Hernia, Recurrent Ventral Hernia
- Keywords
- Hernia, Ventral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no gap closure | – | –no hernia gap closure |
| extracorporal gap closure | – | Procedure: hernia gap closure, Procedure: extracorporal suturing of gapextracorporal hernia gap closure extracorporal suturing of gap |
| intracorporal gap closure | – | Procedure: hernia gap closureintracorporal hernia gap closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after laparoscopic repair of a ventral hernia (including recurrent hernias)
Key inclusion criteria (3 listed)
- hernia repair between 2006 and 2011
- laparoscopic hernia repair using intraperitoneal onlay-mesh (IPOM)
- patient agrees to be surveyed by phone
Key exclusion criteria (2 listed)
- Patient rejects participation in survey
- patient already rejected use of his/her data for research purposes at admittance to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hernia gap closuretype of gap closure during laparoscopic repair of a ventral hernia: none, extracorporal, intracorporal | Procedure or surgery | extracorporal gap closure, intracorporal gap closure |
| extracorporal suturing of gapventral hernia gap is sutured extracorporally | Procedure or surgery | extracorporal gap closure |
Primary outcome
Recurrence rate
Time frame: 7 years
Hernia recurrence at the time of phone survey (2 - 7 years after surgery)
2 secondary outcomes
Time to recurrence
Time frame: 7 years
Patient satisfaction
Time frame: 2 - 7 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sascha Müller, MD principal investigator
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia and Recurrent Ventral Hernia, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.