Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer (TRVL)

February 2, 2016 updated by: Tang Bo, Southwest Hospital, China

A Randomized, Prospective Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer in Urinary, Erectile Function and Anal Function

This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter- preservation outcomes for low rectal cancer.

Study Overview

Detailed Description

Urinary and sexual dysfunction are recognized complications of rectal cancer surgery in men. This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision(LTME) with regard to these functional outcomes.Sphincter- preservation outcomes for low rectal cancer was observed as well.

Study Type

Interventional

Enrollment (Anticipated)

225

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Patients who are acceptable to two surgical procedures for the robot- assisted or laparoscopy-assisted rectal cancer, are willing to randomized trial;
  • 2. Matching the diagnostic criteria;
  • 3. Aged 18-70 years old;
  • 4. Preoperative TNM staging (CT, laparoscopic exploration): cT1-3N0-3M0 (excluding M1, T4);
  • 5. Preoperative ASA 3 scores;
  • 6. There was no history of malignancy, no other malignant tumors by preoperative examination;
  • 7. Without undergoing definitive treatment, such as radiotherapy, chemotherapy or immunotherapy preoperatively;
  • 8. The informed consent form was signed by the patient himself(herself)or his principal agent;
  • 9. In accordance with the international erectile function questionnaire (IIEF) urinary function scale, The urinary sexual function are normal.

Exclusion Criteria:

  • 1. Age less than 18 years old or more than 70 years old;
  • 2. Previous psychiatric patients or patients refused to sign the informed consent;
  • 3. Attending other related clinical studies on surgical treatment of rectal cancer;
  • 4. The patient has a history of malignant tumor, or a combination of other malignant tumors;
  • 5. Patients have been treated with definitive treatment: radiotherapy, chemotherapy or immunotherapy;
  • 6. Patients had received otherper abdominal operations (except for laparoscopic cholecystectomy);
  • 7. ASA >3;
  • 8. Laparoscopic surgical contraindications: such as severe heart lung disease; abdominal wall hernia; diaphragmatic hernia; coagulation disorder; portal hypertension; pregnancy, etc.;
  • 9. Those who has been confirmed to be unable to do a radical resection (T4 stage) for local advanced tumor;
  • 10. Those who have urination sexual dysfunction preoperatively.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot-assisted total mesorectal excision
Robot-assisted total mesorectal excision (RTME) for rectal cancer. Two different RTME procedures were chose to personalized patients. Generally, when the tumor located within 5-15cm from the anal verge, low anterior resection (LAR) was employed, and tumor located below 5cm, abdominoperineal resection (APR) was applied usually.
The Da Vinci Surgical System may help to protect subtle anatomical structure and provide more functional protection when compared to laparoscopic surgery. This study aimed to compare RTME and laparoscopic total mesorectal excision (LTME) for rectal cancer with regard to Urinary, sexual function and sphincter- preservation outcomes.
Active Comparator: Laparoscopic total mesorectal excision
Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer was performed. The Urinary, sexual function and sphincter- preservation outcomes were evaluated.
Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of sexual and urinary dysfunction
Time Frame: One years after surgery
One years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival(DFS )
Time Frame: 3 years disease-free survival
DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause
3 years disease-free survival
Anus preservation rate
Time Frame: One years after surgery
One years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

February 1, 2016

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

February 2, 2016

Last Verified

February 1, 2016

More Information

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.

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