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

Not Applicable
Conditions
Rectal Neoplasms
Registration Number
NCT02673177
Lead Sponsor
Southwest Hospital, China
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
225
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;
    1. Matching the diagnostic criteria;
    1. Aged 18-70 years old;
    1. Preoperative TNM staging (CT, laparoscopic exploration): cT1-3N0-3M0 (excluding M1, T4);
    1. Preoperative ASA 3 scores;
    1. There was no history of malignancy, no other malignant tumors by preoperative examination;
    1. Without undergoing definitive treatment, such as radiotherapy, chemotherapy or immunotherapy preoperatively;
    1. The informed consent form was signed by the patient himself(herself)or his principal agent;
    1. 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;
    1. Previous psychiatric patients or patients refused to sign the informed consent;
    1. Attending other related clinical studies on surgical treatment of rectal cancer;
    1. The patient has a history of malignant tumor, or a combination of other malignant tumors;
    1. Patients have been treated with definitive treatment: radiotherapy, chemotherapy or immunotherapy;
    1. Patients had received otherper abdominal operations (except for laparoscopic cholecystectomy);
    1. ASA >3;
    1. Laparoscopic surgical contraindications: such as severe heart lung disease; abdominal wall hernia; diaphragmatic hernia; coagulation disorder; portal hypertension; pregnancy, etc.;
    1. Those who has been confirmed to be unable to do a radical resection (T4 stage) for local advanced tumor;
    1. Those who have urination sexual dysfunction preoperatively.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Incidence of sexual and urinary dysfunctionOne years after surgery
Secondary Outcome Measures
NameTimeMethod
disease-free survival(DFS )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

Anus preservation rateOne years after surgery

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