Postoperative PainPhase 3COLIBRINCT01420757
Laparoscopic Versus Open Incisional Hernia Repair
A Phase 3 study testing incisional hernia repair in people with Postoperative Pain and Complications, run by Erasmus Medical Center.
Trial summary
Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. If a mesh is used, the defect can be closed tension-free. Using this method, recurrence rates have been reduced to 8-21%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Complications, Recurrence
- What is being tested?
- incisional hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- May 1999to Jul 2011
- Phase
- Phase 3
- 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
- hernia diameter between 3 and 15 cm
- location at the ventral abdominal wall at least 5cm from costae and inguinal area
- indication for elective repair
- age of 18 years or older
- written informed consent.
Who cannot join
- contraindication for pneumoperitoneum
- an absolute contraindication for general anesthesia
- history of open abdomen treatment
- patients participating in other trials
About this study
Official title: Laparoscopic Versus Open Incisional Hernia Repair : A Randomized Clinical Trial
Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. If a mesh is used, the defect can be closed tension-free. Using this method, recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is a relatively new technique in which the mesh is positioned intraperitoneally. Research has shown that this procedure is technical feasible and may have benefits for the patients.
The ongoing debate about the merits of endoscopic versus open incisional hernia repair prompts the need for a level 1 randomized controlled trial.
- Conditions
- Postoperative Pain, Complications, Recurrence
- Being tested
- incisional hernia repair
- Keywords
- operation time, length of hospital stay
- Medical subject headings
- Pain, Postoperative, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incisional hernia repairProcedure or surgery
Tension-free open or laparoscopic incisional hernia repair
| Study group | Role | What they receive |
|---|---|---|
| open | Active comparator | open incisional hernia repair Receives: Procedure: incisional hernia repair |
| laparoscopic | Active comparator | laparoscopic incisional hernia repair Receives: Procedure: incisional hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Measured: 4 weeks
Secondary outcomes (6)
Postoperative analgesics use
Measured: 1 week
complications
Measured: 4 weeks
operation time
Measured: 1 day
length of hospital stay
Measured: 4 weeks
recurrence
Measured: 5 years
mortality
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startMay 1999
- Primary completionDec 2006
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hasan eker, Erasmus Medical Center
- Investigators
- J.F. Lange, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420757
- Sponsor's protocol ID
- COLIBRI trial
- Acronym
- COLIBRI
- Status last verified
- Aug 2011
- First submitted
- 18 Aug 2011
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Incisional Hernia Repair : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01420757
- Acronym / sponsor ID
- COLIBRI / COLIBRI trial
- Conditions
- Postoperative Pain, Complications, Recurrence
- Keywords
- operation time, length of hospital stay
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- May 1999
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Aug 2011 (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.
Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. If a mesh is used, the defect can be closed tension-free. Using this method, recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is a relatively new technique in which the mesh is positioned intraperitoneally. Research has shown that this procedure is technical feasible and may have benefits for the patients.
The ongoing debate about the merits of endoscopic versus open incisional hernia repair prompts the need for a level 1 randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open | Active comparator | Procedure: incisional hernia repairopen incisional hernia repair |
| laparoscopic | Active comparator | Procedure: incisional hernia repairlaparoscopic incisional hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- hernia diameter between 3 and 15 cm
- location at the ventral abdominal wall at least 5cm from costae and inguinal area
- indication for elective repair
- age of 18 years or older
- written informed consent.
Key exclusion criteria (4 listed)
- contraindication for pneumoperitoneum
- an absolute contraindication for general anesthesia
- history of open abdomen treatment
- patients participating in other trials
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 |
|---|---|---|
| incisional hernia repairTension-free open or laparoscopic incisional hernia repair | Procedure or surgery | laparoscopic, open |
Primary outcome
Postoperative pain
Time frame: 4 weeks
6 secondary outcomes
Postoperative analgesics use
Time frame: 1 week
complications
Time frame: 4 weeks
operation time
Time frame: 1 day
length of hospital stay
Time frame: 4 weeks
recurrence
Time frame: 5 years
mortality
Time frame: 5 years
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 22 Aug 2011.
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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.
J.F. Lange, MD, PhD principal investigator
Erasmus Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing incisional hernia repair in people with Postoperative Pain and Complications, run by Erasmus Medical Center.
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 5 inclusion and 4 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 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative pain (time frame: 4 weeks). 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 22 Aug 2011.