跳至主要内容
临床试验/CTRI/2024/09/073200
CTRI/2024/09/073200尚未招募不适用

International Benchmarking Study of Pelvic Exenteration for Rectal Cancer (BeSt-PE)

Surgical Outcomes Research Centre (SOuRCe) at the Royal Prince Alfred Hospital.1 个研究点 分布在 1 个国家目标入组 763 人开始时间: 2024年9月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
763
试验地点
1
主要终点
Morbidity and Mortality

研究概览

简要总结

Pelvic exenteration (PE) is now widely considered the standard of care for appropriately selected patients presenting with locally advanced or recurrent rectal cancer . Due to the encouraging oncological and quality of life outcomes reported for these patients in recent decades, there has been increasing interest in PE globally and a corresponding increase in the number of colorectal surgeons and specialist centres offering exenterative surgery. Such radical surgery is, however, associated with substantial morbidity , functional consequences and at least a temporary reduction in quality of life , and is therefore only justified by the reasonable chance of cure, for which R0 resection margins have been consistently identified as the most important predictor . Several recent comparative studies have demonstrated substantial variability in outcomes of PE between centres, particularly with respect to rates of R0 resection . Benchmarking is a well established concept in economics, where it is a concept commonly applied to quality improvement. More recently benchmarking has been used to assess surgical performance in complex abdominal surgery . In this context, benchmarking involves identifying a procedure of interest and comparing the outcomes of that procedure at a particular centre to the best possible outcomes (the benchmark) . The difference between a centre’s outcome and the benchmark is a measure of the potential for improvement. This study aims to identify the international benchmark thresholds for pelvic exenteration for locally advanced primary and recurrent rectal cancer, i.e. the best possible outcomes achievable at experienced, specialists centres. This will allow centres (particularly those early in their learning curve) to continuously compare their performance to defined international benchmarks and identify areas for potential improvement.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •Locally advanced primary or locally recurrent adenocarcinoma of the rectum •Total PE (complete en bloc resection of the anus, rectum, genitourinary viscera, reproductive internal organs, regional lymph nodes, and peritoneum).

排除标准

  • •Minimally invasive procedures •Synchronous metastases •Palliative intent.

结局指标

主要结局

Morbidity and Mortality

时间窗: 30 Days

Perioperative

时间窗: 30 Days

1)Duration of surgery (minutes)

时间窗: 30 Days

2)Estimated blood loss (mL)

时间窗: 30 Days

3)Total length of hospital stay (days)

时间窗: 30 Days

1)Comprehensive Complication Index, measured at discharge

时间窗: 30 Days

2)Return to the operating theatre

时间窗: 30 Days

3)Mortality, measured at 30 days

时间窗: 30 Days

Oncological

时间窗: 30 Days

1)R0 resection

时间窗: 30 Days

次要结局

  • NA(NA)

研究者

发起方
Surgical Outcomes Research Centre (SOuRCe) at the Royal Prince Alfred Hospital.
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Avanish Saklani

Tata memorial hospital dr ernest Borges marg parel Mumbai

研究点 (1)

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