Abdominal or Transanal TME for Rectal Cancer Therapy

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-01

Study Completion Date

2023-12-31

Brief Summary

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This study assessed whether transanal TME in patients with rectal cancer is superior to open, laparoscopic, and robotic TME (abdominal TME (abTME)) regarding oncological outcome, postoperative morbidity and 90-day mortality.

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Detailed Description

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Rectal cancer accounts for 3.8% of all new cancer diagnosis and for 3.4% of all cancer-related deaths in the world in 2020. Regarding treatment of rectal cancer, it is essential to perform surgery along the anatomical and embryological planes. This technique called total mesorectal excision (TME) reduces the local recurrence rate and improves the survival. Since the early 2000, TME has changed from open to laparoscopic approach due to better results in short-term outcome. Nevertheless, oncological benefits are modest. In 2009 the first ever transanal TME (taTME) war performed. This novel technique combines abdominal with transanal dissection. Because the distal part of the rectum is approached from below, a better visualization of the mesorectal plane resulting in higher rate of free CRM and of complete TME specimen grade (Quirke Score) can be accomplished. However, taTME remains a hot topic in the current scientific literature. In Norway and the Netherlands a higher rate of anastomotic leakage as well as a higher rate of local recurrence (9.5%) with multifocal growth pattern were described.

Conditions

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Survival Postoperative Morbidity Mortality Recurrence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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transanal TME (taTME)

patients with rectal cancer receiving transanal TME

Group Type ACTIVE_COMPARATOR

taTME

Intervention Type PROCEDURE

Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in a rendezvous procedure of an abdominal and a transanal approach.

abdominal TME (abTME)

patients with rectal cancer receiving open, laparoscopic or robotic TME

Group Type ACTIVE_COMPARATOR

abdTME

Intervention Type PROCEDURE

Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach.

Interventions

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taTME

Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in a rendezvous procedure of an abdominal and a transanal approach.

Intervention Type PROCEDURE

abdTME

Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach.

Intervention Type PROCEDURE

Other Intervention Names

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transanal total mesorectal excision abdominal total mesorectal excision

Eligibility Criteria

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Inclusion Criteria

* all patients receiving elective total mesorectal excision

Exclusion Criteria

* diagnosis other than rectal cancer
* partial mesorectal excision
* discontinuity resection (no anastomosis)
* incomplete Staging
* metastatic cancer
* lack of follow-up
* decline of a retrospective data Analysis
* age under 18 years

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No