Incisional HerniaCOMPACNCT00498810
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
A study testing complete repair and partial repair of the abdominal wall in people with Incisional Hernia, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
To compare the complete repair of the abdominal wall at the level of the former incision with only a partial repair at the level of the hernia in patients with an incisional hernia after median laparotomy in a prospective randomized trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- complete repair and partial repair of the abdominal wall
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2007to Jan 2008
- Phase
- Interventional
- 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
Who may be able to join
- Written informed consent from the patient or his/her legal representative
- Incisional hernia requiring elective surgical repair
Who cannot join
- No written informed consent
- Emergency surgery (incarcerated hernia)
- All incisional or parastomal hernias not originating at the midline
- All recurrent hernias
- All patients with mesh placed intra-abdominally during surgery have to be withdrawn
Trial locations and contacts
1 site in 1 country.
About this study
To compare the complete repair of the abdominal wall at the level of the former incision with only a partial repair at the level of the hernia in patients with an incisional hernia after median laparotomy in a prospective randomized trial.
- Conditions
- Incisional Hernia
- Being tested
- complete repair, partial repair of the abdominal wall
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete repairProcedure or surgery
partial repair of the abdominal wallProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
Measured: 1 year
Secondary outcomes (4)
Perioperative morbidity rate
Postoperative pain
Long term complication rate
Recurrence rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: patients had to be converted to the other study arm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Frederik Berrevoet, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498810
- Sponsor's protocol ID
- 2007/241
- Acronym
- COMPAC
- Status last verified
- Jan 2011
- First submitted
- 9 Jul 2007
- Last updated
- 28 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)
- ClinicalTrials.gov ID
- NCT00498810
- Acronym / sponsor ID
- COMPAC / 2007/241
- Conditions
- Incisional Hernia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: patients had to be converted to the other study arm
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Jul 2007 (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.
To compare the complete repair of the abdominal wall at the level of the former incision with only a partial repair at the level of the hernia in patients with an incisional hernia after median laparotomy in a prospective randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent from the patient or his/her legal representative
- Incisional hernia requiring elective surgical repair
Key exclusion criteria (5 listed)
- No written informed consent
- Emergency surgery (incarcerated hernia)
- All incisional or parastomal hernias not originating at the midline
- All recurrent hernias
- All patients with mesh placed intra-abdominally during surgery have to be withdrawn
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 |
|---|---|---|
| complete repair | Procedure or surgery | – |
| partial repair of the abdominal wall | Procedure or surgery | – |
Primary outcome
recurrence rate
Time frame: 1 year
4 secondary outcomes
Perioperative morbidity rate
Postoperative pain
Long term complication rate
Recurrence rate
Time frame: 3 years
Results and safety
The study was stopped early (reason given: patients had to be converted to the other study arm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Frederik Berrevoet, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing complete repair and partial repair of the abdominal wall in people with Incisional Hernia, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 28 Jan 2011. 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 Belgium. 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 was stopped early (reason given: patients had to be converted to the other study arm). Results are not available in the source record.
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: 1 year). 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 28 Jan 2011.