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临床试验/NCT02702089
NCT02702089Unknown不适用

Hartmann's Versus Intersphincetric APE: A Prospective, Multicentre Study

Countess of Chester NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
morbidity

研究概览

简要总结

14,000 new cases of rectal cancer are diagnosed each year, frail and elderly patients represent a rising proportion of these patients. Whilst the gold standard is often to remove the tumour and restore bowel continuity, surgeons will often avoid this procedure in this group of patients as they unfortunately tolerate surgical complications very poorly. Such surgical complications may present with life threatening sepsis, can prolong hospital stay, delay further cancer therapy and in the elderly or frail patient often leads to loss of independence and quality of life. In this setting, there are two alternative procedures (Hartmann's procedure OR intersphincteric APE) that may be used and these are employed in roughly equal measure in the UK (nationwide survey, Dec 2013, unpublished data). It is anecdotally felt that Hartmann's procedure (HP) has a greater risk of surgical complications (30%) and a few small retrospective studies have shown this (1-3), however there are no prospective data to support this view. Whilst some surgeons do choose intersphincteric APE (IAPE) on the basis of a lower surgical complication rate, many do not due to perceived limitations in the technique (longer operating time, risk of tumour perforation), which are unproven. We feel that a larger, prospective dataset is required to demonstrate the superiority of IAPE over HP and convince the remaining surgeons to change procedure. We have explored the possibility of a full randomised trial to answer this question, however this is not feasible due to the difficulty of randomisation of patients. Very little data are available regarding the use of IAPE in the setting of rectal cancer, however many surgeons who do employ the technique, specifically adapt their technique in this setting to reduce the chances of tumour perforation (two stage, stapling off rectum before removing anal canal separately). It is possible that those surgeons who prefer HP have not considered this, and combined with the lack of prospective data are reluctant to change technique. We are confident that if we can demonstrate a significant difference in surgical complication rate and promote a modification to the IAPE surgical technique then we can significantly reduce surgical harm to these frail patients.

详细描述

Having established a network of units (UK and Europe) who are also keen to answer this question we have powered a prospective observational cohort study to demonstrate a significant reduction in surgical complication rate (30% to 15%). In conjunction with an on going Swedish randomised trial we hope that the data from this study will provide compelling evidence for UK surgeons to change practice. If the study reveals only a modest difference in complications, we will use the data gathered to design and reapply again for full funding for an RCT with the additional advantage of being able to clearly demonstrate a network of units capable of recruiting the necessary number of patients. The overarching aims of this study are therefore to:

  1. Determine the difference in surgical complication rates between HP and IAPE
  2. Assess the effect of IAPE technique on intra operative tumour perforation rate

The objectives of the study are to:

  1. Determine surgical complication rate for each procedure (graded by Clavien-Dindo)
  2. Assess impact on secondary outcomes (length of stay, readmission, reintervention, medical complications, time to chemotherapy, quality of life)
  3. Determine if the complication rate in IAPE is dependant on surgical technique
  4. Determine patient and clinician acceptability to randomisation if required

Data Collection

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •• Patients aged over 18 years
  • •Able to provide informed consent
  • •Undergoing elective, locally curative surgery for rectal cancer
  • •Recurrent rectal cancer not a contraindication if pre operative imaging suggests that the tumour can be removed with clear margins
  • •Primary anastomosis not appropriate for reasons of frailty, poor function or risks of anastomotic leak
  • •Local staging completed by MRI
  • •Histological confirmation of adenocarcinoma
  • •Fit for major resection

排除标准

  • •• Pregnant patients
  • •Patients unable to consent
  • •Local palliative resection (systemic metastatic disease not a contraindication)
  • •Suspicion of tumour perforation
  • •Rectal tumours requiring a formal APE due to distal tumour involvement of anorectal junction or pelvic floor

结局指标

主要结局

morbidity

时间窗: 30 days

次要结局

  • Reintervention rate(90 days)
  • Length of stay(90 days)
  • Readmission rate(90 days)
  • Time to chemotherapy(90 days)
  • Quality of life(90 days)

研究者

发起方
Countess of Chester NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dale Vimalachandran

Consultant Surgeon

Countess of Chester NHS Foundation Trust

研究点 (1)

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