Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

NCT ID: NCT05728554

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-03-01

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.

Conditions

Rectal Prolapse

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

Learning session 1

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

Intervention Type: OTHER

Learning session 2

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

Intervention Type: OTHER

Learning session 3

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Kris Vanhaecht

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KU Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

BIC4VMR

Identifier Type: -

Identifier Source: org_study_id