NCT06147492

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

4.8 years

First QC Date

November 17, 2023

Last Update Submit

November 22, 2023

Conditions

Rectal Cancer

Keywords

urinary retention

Outcome Measures

Primary Outcomes (1)

  • urinary retention

    urinary retention rate

    30 days

Study Arms (2)

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 excisionProcedure: Laparoscopic Total Mesorectal Excision

Interventions

transanal total mesorectal excisionPROCEDURE

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

taTME
Laparoscopic Total Mesorectal ExcisionPROCEDURE

Laparoscopic Total Mesorectal Excision

laTMEtaTME

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal NeoplasmsUrinary Retention

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 27, 2023

Study Start

January 30, 2016

Primary Completion

October 30, 2020

Study Completion

October 30, 2023

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

upon reasonable request