Urinary Retention Following taTME VS laTME Total Mesorectal Excision for Rectal Cancer
November 22, 2023 updated by: Yanhong Deng
Urinary Retention Following Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
526
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: laTME
Laparoscopic Total Mesorectal Excision
|
Laparoscopic Total Mesorectal Excision
|
|
Other: taTME
a transanal bottom-up approach was employed for the Total Mesorectal Excision procedure
|
Laparoscopic Total Mesorectal Excision
a transanal bottom-up approach was employed for the TME procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
urinary retention
Time Frame: 30 days
|
urinary retention rate
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2016
Primary Completion (Actual)
October 30, 2020
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
November 17, 2023
First Submitted That Met QC Criteria
November 22, 2023
First Posted (Actual)
November 27, 2023
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 22, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Urination Disorders
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Rectal Neoplasms
- Urinary Retention
Other Study ID Numbers
- GIH-SYip66
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
upon reasonable request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.