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临床试验/NCT05728554
NCT05728554Enrolling By Invitation不适用

BIC4VMR: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy

KU Leuven1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
KU Leuven
入组人数
320
试验地点
1
主要终点
Length of stay

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Length of stay

时间窗: through study completion, an average of 4 months

Number of days in the hospital

次要结局

  • 30 days mortality rate(through study completion, an average of 4 months)
  • 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)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kris Vanhaecht

Professor

KU Leuven

研究点 (1)

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