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

Southwest Hospital, China0 sites225 target enrollmentFebruary 2016

ConditionsRectal Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rectal Neoplasms
Sponsor: Southwest Hospital, China
Enrollment: 225
Primary Endpoint: Incidence of sexual and urinary dysfunction
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

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.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

May 2019

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Southwest Hospital, China

Responsible Party

Principal Investigator

Tang Bo

Principal Investigator

Southwest Hospital, China

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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