The Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.

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Detailed Description

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Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transanal total mesorectal excision

Laparoscopy-assisted transanal total mesorectal excision

Group Type EXPERIMENTAL

Transanal total mesorectal excision

Intervention Type PROCEDURE

Laparoscopy-assisted transanal total mesorectal excision

Interventions

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Transanal total mesorectal excision

Laparoscopy-assisted transanal total mesorectal excision

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age: 20-80 years
* biopsy-proven adenocarcinoma of the rectum
* clinical staging, (T1 or T2 or T3) with N0M0
* Rectal cancer located 4-12 cm from the anal verge
* ECOG performance status 2 or less

Exclusion Criteria

* Synchronous colon cancer or other malignancy
* Obstructing rectal cancer
* Pregnant or breast-feeding
* Receiving any other study agents
* Fecal incontinence
* History of prior colorectal cancer or inflammatory bowel disease
* BMI \> 30
* T3 rectal cancer not treated preoperatively with full-course chemoradiation

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No