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

Rectal Neoplasms Clinical Trial

— TRVL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02673177
• Other study ID #: 2015(43)
• Status: Not yet recruiting
• Phase: N/A
• First received: January 27, 2016
• Last updated: February 2, 2016
• Start date: February 2016
• Est. completion date: May 2019

Study information

• Verified date: February 2016
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: May 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of sexual and urinary dysfunction		One years after surgery	No
Secondary	disease-free survival(DFS )	DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause	3 years disease-free survival	No
Secondary	Anus preservation rate		One years after surgery	No