Urinary Retention Following taTME VS laTME Total Mesorect... | NCT06147492

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

NCT06147492

Sponsor

Yanhong Deng

Status

Completed

Last Update Posted

Nov 27, 2023Actual

Enrollment

526Actual

Phase

Not Applicable

Conditions

Rectal Cancer

Interventions

transanal total mesorectal excision
Laparoscopic Total Mesorectal Excision

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2016Actual

Primary Completion Date

Oct 30, 2020Actual

Completion Date

Oct 30, 2023Actual

First Submitted Date

Nov 17, 2023

First Submission Date that Met QC Criteria

Nov 22, 2023

First Posted Date

Nov 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2023

Last Update Posted Date

Nov 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

526Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laTME	Other	Laparoscopic Total Mesorectal Excision	Procedure: Laparoscopic Total Mesorectal Excision
taTME	Other	a transanal bottom-up approach was employed for the Total Mesorectal Excision procedure	Procedure: transanal total mesorectal excision Procedure: Laparoscopic Total Mesorectal Excision

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transanal total mesorectal excision	Procedure	a transanal bottom-up approach was employed for the TME procedure	taTME

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
urinary retention	urinary retention rate	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

upon reasonable request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms
D016055	Urinary Retention

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided