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Urinary Retention Following taTME VS laTME Total Mesorectal Excision for Rectal Cancer

NCT ID: NCT06147492

Last Updated: 2023-11-27

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

526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-30

Study Completion Date

2023-10-30

Brief Summary

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A comprehensive study with prospectively collected data. These patients were assigned to either the taTME group or the laTME group according to the surgery procedure received

Detailed Description

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Transanal total mesorectal excision has emerged as a potential solution to certain limitations associated with laparoscopic total mesorectal excision in rectal cancer patients. Differences in surgical approaches have raised questions regarding their impact on the risk of postoperative urinary retention, with limited data available from large scale study.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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laTME

Laparoscopic Total Mesorectal Excision

Group Type OTHER

Laparoscopic Total Mesorectal Excision

Intervention Type PROCEDURE

Laparoscopic Total Mesorectal Excision

taTME

a transanal bottom-up approach was employed for the Total Mesorectal Excision procedure

Group Type OTHER

transanal total mesorectal excision

Intervention Type PROCEDURE

a transanal bottom-up approach was employed for the TME procedure

Laparoscopic Total Mesorectal Excision

Intervention Type PROCEDURE

Laparoscopic Total Mesorectal Excision

Interventions

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transanal total mesorectal excision

a transanal bottom-up approach was employed for the TME procedure

Intervention Type PROCEDURE

Laparoscopic Total Mesorectal Excision

Laparoscopic Total Mesorectal Excision

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age range from 18 to 65 years,
* Diagnosed with rectal cancer at clinical tumor node metastasis stages II or III.
* Palpable tumor determined by digital rectal examination or proctoscopy
* The distal border of the tumor located within 12 cm from the anal verge

Exclusion Criteria

* Patients presenting clear indications of pelvic side wall involvement or distant metastasis
* Uncontrolled hypertension or cardiovascular disease
* Patients with synchronous colon cancer
* History of other malignancies within the past 5 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yanhong Deng

OTHER

Sponsor Role lead

Responsible Party

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Yanhong Deng

Director

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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GIH-SYip66

Identifier Type: -

Identifier Source: org_study_id