Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy (BIC4VMR)

BIC4VMR: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Rectal Prolapse
• Intervention / Treatment: Other: Learning session 1; Other: Learning session 2; Other: Learning session 3

• Study Type: Observational
• Enrollment (Estimated): 320

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patient with rectal prolaps admitted for planned surgery

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Number of days in the hospital	through study completion, an average of 4 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Pelvic Organ Prolapse; Prolapse; Rectal Prolapse
• Other Study ID Numbers: BIC4VMR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No