Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

NCT05728554 | Enrolling By Invitation

• 1 other identifier: BIC4VMR
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Length of stay

  Number of days in the hospital

  through study completion, an average of 4 months

Secondary Outcomes (4)

• In-hospital complication rate

  through study completion, an average of 4 months

• in-hospital mortality

  through study completion, an average of 4 months

• 30 day readmission rate

  through study completion, an average of 4 months

• 30 days mortality rate

  through study completion, an average of 4 months

Interventions

Learning session 1 OTHER

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

Learning session 2 OTHER

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

Learning session 3 OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with rectal prolaps admitted for planned surgery

You may qualify if:

• Minimum age of 18 years;
• Elective admission for ventral mesh rectopexy
• Total rectal prolapse
• Grade III Internal prolapse with incontinence or obstructed defaecation

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

BE (1)