Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

Rectal Prolapse Clinical Trial

— BIC4VMR  

Official title:

BIC4VMR: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05728554
• Other study ID #: BIC4VMR
• Status: Enrolling by invitation
• Start date: March 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 320
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

Intervention

Other:
• Learning session 1
Learn form international report, Explain key interventions, Explain BIC methodology, Retrospective patient record analysis, Team measures
• Learning session 2
Feedback report, Share (inter)national best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis
• Learning session 3
Feedback report, Share best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis, Team measures

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Number of days in the hospital	through study completion, an average of 4 months
Secondary	In-hospital complication rate	Re-intervention, wound complications, surgical site infection, ileus and postoperative bleeding	through study completion, an average of 4 months
Secondary	in-hospital mortality	Mortality during hospitalization	through study completion, an average of 4 months
Secondary	30 day readmission rate	Readmission rate within 30 days after discharge	through study completion, an average of 4 months
Secondary	30 days mortality rate	Mortality rate within 30 days after discharge	through study completion, an average of 4 months