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

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ClinicalTrials.gov Identifier: NCT02673177
Recruitment Status : Unknown
Verified February 2016 by Tang Bo, Southwest Hospital, China.
Recruitment status was:  Not yet recruiting
First Posted : February 3, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Tang Bo, 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.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Procedure: robot-assisted total mesorectal excision Procedure: laparoscopic total mesorectal excision Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer in Urinary, Erectile Function and Anal Function
Study Start Date : February 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: 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.
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.

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




Primary Outcome Measures :
  1. Incidence of sexual and urinary dysfunction [ Time Frame: One years after surgery ]

Secondary Outcome Measures :
  1. disease-free survival(DFS ) [ Time Frame: 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

  2. Anus preservation rate [ Time Frame: One years after surgery ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Tang Bo, Principal Investigator, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02673177    
Other Study ID Numbers: 2015(43)
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Tang Bo, Southwest Hospital, China:
robot-assisted total mesorectal excision(RTME)
laparoscopic total mesorectal excision(LTME)
urinary function
sexual function
sphincter- preservation
low rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases