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

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: Rectal Cancer
• Intervention / Treatment: Procedure: Laparoscopic Total Mesorectal Excision; Procedure: transanal total mesorectal excision

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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: laTME; Laparoscopic Total Mesorectal Excision	Procedure: Laparoscopic Total Mesorectal Excision; Laparoscopic Total Mesorectal Excision
Other: taTME; a transanal bottom-up approach was employed for the Total Mesorectal Excision procedure	Procedure: Laparoscopic Total Mesorectal Excision; Laparoscopic Total Mesorectal Excision; Procedure: transanal 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	urinary retention rate	30 days

Collaborators and Investigators

• Sponsor: Yanhong Deng

Study record dates

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: urinary retention
• 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