A LAparoscopic and TransAnal Total Mesorectal Excision (TME) for Rectal Cancer Trial

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

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-06-30

Brief Summary

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All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed.

Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.

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Detailed Description

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The design is comparative and prospective, we will compare specimens from patients operated at our institution during the last year with standard open or laparoscopic approach with patients operated with the new technique. Patients in the control arm will be patients operated prior to the commencement of the new technique or patients not eligible or possible to include in the study.

It is possible to obtain a macroscopically and microscopically adequate specimen after a combined approach with laparoscopic and transanal TME compared to open or laparoscopic conventional TME.

Conditions

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Colorectal Neoplasm

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Laparoscopic total mesorectal excision

Patients operated with laparoscopic total mesorectal surgery for rectal cancer

No interventions assigned to this group

transanal total mesorectal excision

Patients operated with a combined transanal and laparosocopic total mesorectal surgery for rectal cancer

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* presenting with a rectal cancer possible to operate with a total mesorectal excision and an anastomosis according to the local multidisciplinary conference
* possible to operate with laparoscopic technique
* possible to operate in regard to concomitant disease
* giving informed consent to participate