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Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer

NCT03359616 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2017-12-02

No results posted yet for this study

Summary

Total mesorectal excision (TME) has been prevailingly accepted as a crucial surgical intervention within the latest oncological therapeutic regime for mid-low rectal cancer. However, surgical dissection under the restricted pelvic anatomical structure, added by obesity and many other general factors, remains challenging for classical open and laparoscopic patterns, particularly in male cases. The introduction of transanal total mesorectal excision (TaTME) offers an optimal pattern for the surgical resection of mid-low rectal cancer, circumventing the conventional anatomical limits while bringing forward considerable advantages by direct dissection. Noteworthy, the surgical techniques of TaTME is initially established, with the mortality/morbidity and the oncological safety unverified. The studies that focus on the comparison between TaTME and laparoscopic TME (LaTME) remain sparse. Therefore, the features of TaTME, both in short and long terms, await further consolidation by clinical trials. Herein, this single centered, interventional study protocol is established to collect initial clinical data on both the safety and efficacy of the TaTME in comparison with LaTME in East Chinese patients with mid-low rectal cancer.

Conditions

Interventions

PROCEDURE

Transanally curable surgical resection

Transanally, the rectal cancer will be mobilized with oncological principle of total mesorectal excision

PROCEDURE

Laparoscopic total mesorectal excision

Conventionally by laparoscopic surgery, the rectal cancer will be mobilized with oncological principle of total mesorectal excision

Sponsors & Collaborators

  • Shanghai Minimally Invasive Surgery Center

    lead OTHER

Principal Investigators

  • Minhua Zheng, M.D., PhD. · MISC, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-01-01
Completion
2022-01-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03359616 on ClinicalTrials.gov