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Short-term Outcomes of Transanal Total Mesorectal Excision With Structured Training Curriculums in China

NCT ID: NCT05108753

Last Updated: 2021-11-05

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

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2021-09-30

Brief Summary

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Transanal total mesorectal excision (TaTME) is an alternative for mid-low rectal cancer. In China, this procedure has been performed in high-volume centers with structured training curriculums. This study aimed to evaluate the short-term outcomes during the initial implementation of the TaTME procedure in high-volume centers who followed structured training curriculums in China.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

5 patients underwent TaTME under proctoring

Procedure/Surgery

Intervention Type OTHER

Transanal Total Mesorectal Excision

Group 2

the first 10 patients underwent TaTME without proctoring

Procedure/Surgery

Intervention Type OTHER

Transanal Total Mesorectal Excision

Group 3

the second 10 patients underwent TaTME without proctoring

Procedure/Surgery

Intervention Type OTHER

Transanal Total Mesorectal Excision

Interventions

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Procedure/Surgery

Transanal Total Mesorectal Excision

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 75 years
* American Society of Anesthesiologists (ASA) score I to III
* A biopsy proven histological diagnosis of rectal carcinoma
* Undergoing transanal total mesorectal excision

Exclusion Criteria

* Pregnant or lactating women
* Synchronous rectal carcinoma
* History of colorectal cancer or other malignant tumors
* Clinical evidence of metastasis
* Emergency procedure
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Minimally Invasive Surgery Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Minimally Invasive Surgery Center

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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MISC-TaTME-RETRO

Identifier Type: -

Identifier Source: org_study_id