ClinicalTrials.gg
Enrolling by invitationNCT05728554BIC4VMRUpdated Feb 7, 2024

Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

An observational study in Rectal Prolapse, sponsored by KU Leuven. Enrolling by invitation at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by KU Leuven · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
320
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Rectal Prolapse

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03

In context

Rectal Prolapse

55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.

This study's planned enrollment of 320 is above the median of 200 across 21 observational studies indexed under Rectal Prolapse.

Browse Rectal Prolapse studies →

Lead sponsor

KU Leuven is the lead sponsor of 373 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patient with rectal prolaps admitted for planned surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Minimum age of 18 years;
  • Elective admission for ventral mesh rectopexy
  • Total rectal prolapse
  • Grade III Internal prolapse with incontinence or obstructed defaecation

Exclusion criteria

Exclusion Criteria:

  • Colpo posterior
  • Patients diagnosed with severe dementia (DSM IV) or severe concomitant disease that may affect very short-term outcome ( less than 3 months) and hence influence deviations from standard acute care.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
320 participants (estimated)
Patient registry
No

Interventions

  • OtherLearning session 1

    Learn form international report, Explain key interventions, Explain BIC methodology, Retrospective patient record analysis, Team measures

  • OtherLearning session 2

    Feedback report, Share (inter)national best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis

  • OtherLearning session 3

    Feedback report, Share best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis, Team measures

06

What researchers measure

Primary outcomes

  1. Length of stay

    Number of days in the hospital

    Time frame: through study completion, an average of 4 months

Secondary outcomes

  1. In-hospital complication rate

    Re-intervention, wound complications, surgical site infection, ileus and postoperative bleeding

    Time frame: through study completion, an average of 4 months

  2. in-hospital mortality

    Mortality during hospitalization

    Time frame: through study completion, an average of 4 months

  3. 30 day readmission rate

    Readmission rate within 30 days after discharge

    Time frame: through study completion, an average of 4 months

  4. 30 days mortality rate

    Mortality rate within 30 days after discharge

    Time frame: through study completion, an average of 4 months

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2023 (actual). Primary completion is estimated for Mar 2025, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2023
First posted
Feb 15, 2023
StartActual
Mar 1, 2023
Primary completionEst.
Mar 1, 2025
CompletionEst.
Mar 1, 2026
Last update
Feb 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05728554
Lead sponsor
KU Leuven
Responsible party
Kris Vanhaecht (Professor, KU Leuven) — Principal investigator
First posted
Feb 15, 2023
Start date
Mar 1, 2023
Primary completion
Mar 1, 2025 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Feb 7, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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