Rectal ProlapseBIC4VMRNCT05728554
Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy
An observational study of Rectal Prolapse, run by KU Leuven at 1 site in Belgium.
Trial summary
Different studies showed large variation between care processes in multiple diseases, this leads to large variation in outcomes. Better adherence to evidence-based guidelines for these diseases can reduce this variation and can improve the health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- Learning session 1, Learning session 2 and Learning session 3
- How many people
- 320 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2023to 1 Mar 2026
- 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
- Adult, Older adult
Study population: Patient with rectal prolaps admitted for planned surgery
Who may be able to join
- Minimum age of 18 years;
- Elective admission for ventral mesh rectopexy
- Total rectal prolapse
- Grade III Internal prolapse with incontinence or obstructed defaecation
Who cannot join
- Colpo posterior
- Patients diagnosed with severe dementia (DSM IV) or severe concomitant disease that may affect very short-term outcome (life expectancy less than 3 months) and hence influence deviations from standard acute care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BIC4VMR: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy
Different studies showed large variation between care processes in multiple diseases, this leads to large variation in outcomes. Better adherence to evidence-based guidelines for these diseases can reduce this variation and can improve the health outcomes.
Ventral mesh rectopexy has gained popularity in Europe to treat different rectal prolapse syndromes. This procedure has been shown to achieve acceptable anatomic results with low recurrence rates, few complications, and improvements of both constipation and fecal incontinence. However, there is limited data on the care process and outcomes. Moreover, there is no insight in the variation between different centers for patients undergoing ventral mesh rectopexy.
This study aims to map the variation in care for patients undergoing ventral mesh rectopexy in Flemish hospitals and to get an overview about the variation within and between these hospitals. Hereby, this will be a repeat of the studies for colorectal cancer, fragility hip fractures, stroke and breast cancer surgery.
- Conditions
- Rectal Prolapse
- Being tested
- Learning session 1, Learning session 2, Learning session 3
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning session 1Other
Learn form international report, Explain key interventions, Explain BIC methodology, Retrospective patient record analysis, Team measures
Learning session 2Other
Feedback report, Share (inter)national best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis
Learning session 3Other
Feedback report, Share best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis, Team measures
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Number of days in the hospital
Measured: through study completion, an average of 4 months
Secondary outcomes (4)
In-hospital complication rate
Re-intervention, wound complications, surgical site infection, ileus and postoperative bleeding
Measured: through study completion, an average of 4 months
in-hospital mortality
Mortality during hospitalization
Measured: through study completion, an average of 4 months
30 day readmission rate
Readmission rate within 30 days after discharge
Measured: through study completion, an average of 4 months
30 days mortality rate
Mortality rate within 30 days after discharge
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal ProlapseStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kris Vanhaecht, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728554
- Sponsor's protocol ID
- BIC4VMR
- Acronym
- BIC4VMR
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIC4VMR: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy
- ClinicalTrials.gov ID
- NCT05728554
- Acronym / sponsor ID
- BIC4VMR / BIC4VMR
- Conditions
- Rectal Prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 15 Feb 2023 (actual)
- 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.
Different studies showed large variation between care processes in multiple diseases, this leads to large variation in outcomes. Better adherence to evidence-based guidelines for these diseases can reduce this variation and can improve the health outcomes.
Ventral mesh rectopexy has gained popularity in Europe to treat different rectal prolapse syndromes. This procedure has been shown to achieve acceptable anatomic results with low recurrence rates, few complications, and improvements of both constipation and fecal incontinence. However, there is limited data on the care process and outcomes. Moreover, there is no insight in the variation between different centers for patients undergoing ventral mesh rectopexy.
This study aims to map the variation in care for patients undergoing ventral mesh rectopexy in Flemish hospitals and to get an overview about the variation within and between these hospitals. Hereby, this will be a repeat of the studies for colorectal cancer, fragility hip fractures, stroke and breast cancer surgery.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with rectal prolaps admitted for planned surgery
Key inclusion criteria (4 listed)
- Minimum age of 18 years;
- Elective admission for ventral mesh rectopexy
- Total rectal prolapse
- Grade III Internal prolapse with incontinence or obstructed defaecation
Key exclusion criteria (2 listed)
- Colpo posterior
- Patients diagnosed with severe dementia (DSM IV) or severe concomitant disease that may affect very short-term outcome (life expectancy less than 3 months) and hence influence deviations from standard acute care.
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 |
|---|---|---|
| Learning session 1Learn form international report, Explain key interventions, Explain BIC methodology, Retrospective patient record analysis, Team measures | Other | – |
| Learning session 2Feedback report, Share (inter)national best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis | Other | – |
| Learning session 3Feedback report, Share best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis, Team measures | Other | – |
Primary outcome
Length of stay
Time frame: through study completion, an average of 4 months
Number of days in the hospital
4 secondary outcomes
In-hospital complication rate
Time frame: through study completion, an average of 4 months
in-hospital mortality
Time frame: through study completion, an average of 4 months
30 day readmission rate
Time frame: through study completion, an average of 4 months
30 days mortality rate
Time frame: through study completion, an average of 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rectal Prolapse, run by KU Leuven 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 4 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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?
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?
Length of stay (time frame: through study completion, an average of 4 months). 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 7 Feb 2024.