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

Not Applicable

• Conditions: Rectal Neoplasms
• Interventions: Procedure: laparoscopic total mesorectal excision; Procedure: robot-assisted total mesorectal excision

• 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.

Study Timeline

• Study First Submitted: 2016-01-27
• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-01
• Last Update Submitted: 2016-02-02
• Study First Posted: 2016-02-03
• Last Update Posted: 2016-02-04
• Primary Completion: 2018-05
• Study Completion: 2019-05

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;
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic total mesorectal excision	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.
Robot-assisted total mesorectal excision	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.

Primary Outcome Measures

Name	Time	Method
Incidence of sexual and urinary dysfunction	One years after surgery

Secondary Outcome Measures

Name	Time	Method
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 rate	One years after surgery