Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy (BIC4VMR)

• ClinicalTrials.gov Identifier: NCT05728554
• Recruitment Status: Enrolling by invitation
• First Posted: February 15, 2023
• Last Update Posted: February 7, 2024
• Sponsor: KU Leuven
• Information provided by (Responsible Party): Kris Vanhaecht, KU Leuven

Study Description

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.

Condition or disease	Intervention/treatment
Rectal Prolapse	Other: Learning session 1; Other: Learning session 2; Other: Learning session 3

Study Design

• Study Type: Observational
• Estimated Enrollment: 320 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: BIC4VMR: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy
• Actual Study Start Date: March 1, 2023
• Estimated Primary Completion Date: March 1, 2025
• Estimated Study Completion Date: March 1, 2026

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. Length of stay [ Time Frame: through study completion, an average of 4 months ]
   Number of days in the hospital

Secondary Outcome Measures :

1. In-hospital complication rate [ Time Frame: through study completion, an average of 4 months ]
   Re-intervention, wound complications, surgical site infection, ileus and postoperative bleeding
2. in-hospital mortality [ Time Frame: through study completion, an average of 4 months ]
   Mortality during hospitalization
3. 30 day readmission rate [ Time Frame: through study completion, an average of 4 months ]
   Readmission rate within 30 days after discharge
4. 30 days mortality rate [ Time Frame: through study completion, an average of 4 months ]
   Mortality rate within 30 days after discharge

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

Patient with rectal prolaps admitted for planned surgery

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.

Contacts and Locations

Locations

Belgium

KU Leuven

Leuven, Belgium, 3000

Sponsors and Collaborators

KU Leuven

More Information

• Responsible Party: Kris Vanhaecht, Professor, KU Leuven
• ClinicalTrials.gov Identifier: NCT05728554
• Other Study ID Numbers: BIC4VMR
• First Posted: February 15, 2023
• Last Update Posted: February 7, 2024
• Last Verified: February 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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