Clinical trial NCT02673177: Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer
Official title: A Randomized, Prospective Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer in Urinary, Erectile Function and Anal Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Neoplasms
Keywords: robot-assisted total mesorectal excision(RTME)
laparoscopic total mesorectal excision(LTME)
urinary function
sexual function
sphincter- preservation
low rectal cancer
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of sexual and urinary dysfunction
timeFrame: One years after surgery
Secondary outcomes:
measure: disease-free survival(DFS )
timeFrame: 3 years disease-free survival
measure: Anus preservation rate
timeFrame: One years after surgery
Other outcomes:
Locations:
Study officials:
References: