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

Tracking Information

• First Submitted Date: February 6, 2023
• First Posted Date: February 15, 2023
• Last Update Posted Date: February 7, 2024
• Actual Study Start Date: March 1, 2023
• Estimated Primary Completion Date: March 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 6, 2023)

Length of stay [ Time Frame: through study completion, an average of 4 months ]

Number of days in the hospital

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 6, 2023)

• 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
• in-hospital mortality [ Time Frame: through study completion, an average of 4 months ]
  Mortality during hospitalization
• 30 day readmission rate [ Time Frame: through study completion, an average of 4 months ]
  Readmission rate within 30 days after discharge
• 30 days mortality rate [ Time Frame: through study completion, an average of 4 months ]
  Mortality rate within 30 days after discharge

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy
• Official Title: BIC4VMR: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patient with rectal prolaps admitted for planned surgery
• Condition: Rectal Prolapse

Intervention

• 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

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: February 6, 2023): 320
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2026
• Estimated Primary Completion Date: March 1, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT05728554
• Other Study ID Numbers: BIC4VMR
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kris Vanhaecht, KU Leuven
• Original Responsible Party: Same as current
• Current Study Sponsor: KU Leuven
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: KU Leuven
• Verification Date: February 2024