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

NCT ID: NCT02673177

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2019-05-31

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.

Conditions

Rectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

robot-assisted total mesorectal excision

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

laparoscopic total mesorectal excision

Intervention Type: PROCEDURE

Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer.

Interventions

robot-assisted total mesorectal excision

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.

Intervention Type: PROCEDURE

laparoscopic total mesorectal excision

Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Tang Bo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2015(43)

Identifier Type: -

Identifier Source: org_study_id