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

Primary Purpose

Rectal Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
robot-assisted total mesorectal excision
laparoscopic total mesorectal excision
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring robot-assisted total mesorectal excision(RTME), laparoscopic total mesorectal excision(LTME), urinary function, sexual function, sphincter- preservation, low rectal cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Robot-assisted total mesorectal excision

    Laparoscopic total mesorectal excision

    Arm Description

    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.

    Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer was performed. The Urinary, sexual function and sphincter- preservation outcomes were evaluated.

    Outcomes

    Primary Outcome Measures

    Incidence of sexual and urinary dysfunction

    Secondary Outcome Measures

    disease-free survival(DFS )
    DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause
    Anus preservation rate

    Full Information

    First Posted
    January 27, 2016
    Last Updated
    February 2, 2016
    Sponsor
    Southwest Hospital, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02673177
    Brief Title
    Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer
    Acronym
    TRVL
    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

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    May 2018 (Anticipated)
    Study Completion Date
    May 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Southwest Hospital, China

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Neoplasms
    Keywords
    robot-assisted total mesorectal excision(RTME), laparoscopic total mesorectal excision(LTME), urinary function, sexual function, sphincter- preservation, low rectal cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    225 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Robot-assisted total mesorectal excision
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Laparoscopic total mesorectal excision
    Arm Type
    Active Comparator
    Arm Description
    Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer was performed. The Urinary, sexual function and sphincter- preservation outcomes were evaluated.
    Intervention Type
    Procedure
    Intervention Name(s)
    robot-assisted total mesorectal excision
    Intervention Description
    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
    Intervention Name(s)
    laparoscopic total mesorectal excision
    Intervention Description
    Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer.
    Primary Outcome Measure Information:
    Title
    Incidence of sexual and urinary dysfunction
    Time Frame
    One years after surgery
    Secondary Outcome Measure Information:
    Title
    disease-free survival(DFS )
    Description
    DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause
    Time Frame
    3 years disease-free survival
    Title
    Anus preservation rate
    Time Frame
    One years after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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