Skip to content

Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

BIC4VMR: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05728554
Acronym
BIC4VMR
Enrollment
320
Registered
2023-02-15
Start date
2023-03-01
Completion date
2026-03-01
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Prolapse

Brief 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.

Interventions

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

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

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

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Length of staythrough study completion, an average of 4 monthsNumber of days in the hospital

Secondary

MeasureTime frameDescription
In-hospital complication ratethrough study completion, an average of 4 monthsRe-intervention, wound complications, surgical site infection, ileus and postoperative bleeding
in-hospital mortalitythrough study completion, an average of 4 monthsMortality during hospitalization
30 day readmission ratethrough study completion, an average of 4 monthsReadmission rate within 30 days after discharge
30 days mortality ratethrough study completion, an average of 4 monthsMortality rate within 30 days after discharge

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026