BIC4VMR: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

Sponsor
KU Leuven (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05728554
Collaborator
(none)
320
1
24
13.3

Study Details

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 Phase
  • Other: Learning session 1
  • Other: Learning session 2
  • Other: Learning session 3

Study Design

Study Type:
Observational
Anticipated Enrollment :
320 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
BIC4VMR: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Length of stay [through study completion, an average of 4 months]

    Number of days in the hospital

Secondary Outcome Measures

  1. In-hospital complication rate [through study completion, an average of 4 months]

    Re-intervention, wound complications, surgical site infection, ileus and postoperative bleeding

  2. in-hospital mortality [through study completion, an average of 4 months]

    Mortality during hospitalization

  3. 30 day readmission rate [through study completion, an average of 4 months]

    Readmission rate within 30 days after discharge

  4. 30 days mortality rate [through study completion, an average of 4 months]

    Mortality rate within 30 days after discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Site City State Country Postal Code
1 KU Leuven Leuven Belgium 3000

Sponsors and Collaborators

  • KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kris Vanhaecht, Professor, KU Leuven
ClinicalTrials.gov Identifier:
NCT05728554
Other Study ID Numbers:
  • BIC4VMR
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2023