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临床试验/NCT00534131
NCT00534131已完成不适用

A Multicentre Trial of the Anterior Perineal PlanE for Ultra Low Anterior Resection of the Rectum (The APPEAR Technique) in the Prevention of Permanent Stoma in Benign and Malignant Disease

Queen Mary University of London2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2004年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Oncological safety assessment - where appropriate

研究概览

简要总结

Anal sphincter preserving operations are now commonplace for both cancer and non-cancerous rectal diseases. However, this has not always been the case and this development has been facilitated by the invention of circular stapling instruments, which allow the bowel to be reconnected to the anal sphincters, where it would almost be impossible to do so manually. Nevertheless, some patients still require a permanent ostomy, as even with stapling devices ultra low joins of the bowel and sphincter muscles cannot always be performed by a conventional surgery. Therefore, a variety of alternative techniques have been proposed to avoid a permanent ostomy, but these have not become widespread due to the technical difficulty in performing them, their failure to completely eradicate rectal disease, and the damage they inflict upon the anal sphincters resulting in poor bowel function after surgery.

The ideal ultra low sphincter preserving operation should remove the rectal disease entirely, allow the small or large bowel to be safely joined to the anal sphincters under direct vision, and retain the sphincter mechanism in its entirety. We propose such a technique that we term the APPEAR procedure, which approaches the lower third of the rectum via an incision between the scrotum or vagina, and the anal sphincters. This procedure preserves sphincter integrity, and allows either a stapled or manual join of the bowel to the sphincter mechanism, under direct vision. This trial is being conducted as a pilot study, with the procedure only offered to patients for whom a conventional sphincter saving procedure was technically impossible, or contraindicated.

详细描述

This study is recruiting patients with distal third rectal pathology, for whom a conventional sphincter saving procedure is contraindicated, or likely to be technically impossible.

Recruited patients will initially undergo trial dissection by conventional sphincter preserving surgical techniques, which if successful will result in patients entering study arm 1.

However, should this not be possible, a trial anterior perineal dissection will be attempted, with patients entered into study arm 2 if perineal dissection is adequate to allow full rectal excision, and preserve sphincter integrity.

If during a trial of anterior perineal dissection it is decided that sphincter preservation is not safe, or will not allow eradication of rectal disease, conventional proctectomy will be performed, with patients entering study arm 3.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • All patients regardless of sex
  • Undergoing surgery (with curative intent) to excise the lower third of the rectum who may require a permanent stoma
  • Deemed suitable by multidisciplinary team.

排除标准

  • Patients under the age of 16
  • Patients in whom sphincter preservation has already been deemed inappropriate for medical or surgical reasons (e.g. by an MDT for oncological cure), or in whom surgery has been deemed generally inappropriate.

结局指标

主要结局

Oncological safety assessment - where appropriate

时间窗: 5 years

Surgical Safety Assessment

时间窗: 1 year

Functional assessment (faecal continence)

时间窗: 5 years

Yield (within each arm of study)

时间窗: 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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