Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

• Conditions: Rectal Prolapse

• Registration Number: NCT05728554
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Study Start: 2023-03-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length of stay	through study completion, an average of 4 months	Number of days in the hospital

Secondary Outcome Measures

Name	Time	Method
30 days mortality rate	through study completion, an average of 4 months	Mortality rate within 30 days after discharge
In-hospital complication rate	through study completion, an average of 4 months	Re-intervention, wound complications, surgical site infection, ileus and postoperative bleeding
in-hospital mortality	through study completion, an average of 4 months	Mortality during hospitalization
30 day readmission rate	through study completion, an average of 4 months	Readmission rate within 30 days after discharge

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Belgium