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临床试验/NCT04948762
NCT04948762Unknown不适用

A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

St Vincent's University Hospital, Ireland1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Resection status

研究概览

简要总结

Minimally-invasive surgery (MIS) techniques have revolutionised the approach to rectal cancer surgery. With increasing experience, surgeons have began to utilise these platforms increasingly in the context of pelvic exenteration (PE). This observational retrospective review plans to assess the volume of PE being performed on a global basis and to assess the comparative outcomes associated with each technique in order to assess the optimal approach to radical pelvic surgery.

详细描述

Pelvic exenteration (extended pelvic multi-visceral resection) is a radical procedure that offers potential long-term cure in appropriately selected cases of locally advanced and recurrent pelvic cancers. It was first described by Alexander Brunschwig in 1948 as a viable palliative option for advanced gynaecological cancer. However, over the last 70 years, changes in surgical oncology practices have seen its role extended to include other advanced non-gynaecological cancers (locally advanced colorectal, urological, and sarcomatous neoplasms).

Although these procedures pose a significant challenge for the operating surgeon, improved surgical techniques, technology, and reconstructive options have facilitated more radical resections. Despite improved surgical options, patients still have considerable post-operative morbidity and negative impact to quality of life. However, non-surgical management options result in poor prognosis with only 3% survival at five-years. Pelvic exenteration in appropriately-selected patients offers the only hope of long-term survival.

Over the last few decades with improved perioperative management and better surgical techniques, more aggressive visceral, soft tissue and bony resections are performed. The development of minimally invasive surgery (MIS) platforms has also evolved substantially, especially regarding pelvic surgery. There are some recent sporadic (low-volume) reports highlighting the potential role for MIS exenterative surgery, however many reports have been heterogeneous and single-centre. The aim of this retrospective review is to compare the volume, disease characteristics and surgical outcomes between open, laparoscopic and robotic pelvic exenterations, and to assess the initial experience of MIS platforms in multiple specialist centres worldwide.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Histologically proven locally advanced or recurrent RECTAL cancer
  • Aged over 18 years
  • Undergoing a multi-visceral extended pelvic resection
  • Procedure took place within the specified timeframe (July 2016 - July 2021)

排除标准

  • Extra-pelvic/ non-resectable metastatic or peritoneal disease
  • Palliative pelvic exenteration
  • Insufficient patient follow-up data

结局指标

主要结局

Resection status

时间窗: July 2016 - July 2021

Completeness of the surgical resection (R0, R1 or R2)

次要结局

  • Operation time(July 2016 - July 2021)
  • Return of bowel function(July 2016 - July 2021)
  • Morbidity(July 2016 - July 2021)
  • Blood loss(July 2016 - July 2021)
  • Conversion rate(July 2016 - July 2021)
  • Length of stay(July 2016 - July 2021)
  • Analgesic Requirements(July 2016 - July 2021)

研究者

发起方
St Vincent's University Hospital, Ireland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Des Winter

Professor Desmond C Winter

St Vincent's University Hospital, Ireland

研究点 (1)

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