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Robotic Assisted Transanal Total Mesorectal Excision Surgery for Rectal Cancer in Low Site

Primary Purpose

Rectal Neoplasms

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
R-TME
R-TaTME
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring transanal surgery, robotic surgery, total mesorectal excision

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adenocarcinoma of the rectum by biopsy
  • the lower edge of the tumor from the anal margin less than 8cm according to MRI or rigid endoscopy
  • tumor diameter less than 4cm
  • baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)
  • tolerable to surgery
  • be able to understand and willing to participate in this trial with signature

Exclusion Criteria:

  • history of malignant colorectal neoplasia
  • recent diagnosis with other malignancies
  • patients requiring emergency surgery such as obstruction，perforation and bleeding
  • tumor involving adjacent organs, anal sphincter, or levator ani muscle muti-focal colorectal cancer
  • preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence history of inflammatory bowel disease or familial adenomatous polyposis
  • participating in other clinical trails
  • History of pelvic radiation
  • BMI > 40
  • Large uterine fibroids
  • can not tolerate the surgery
  • history of serious mental illness
  • pregnancy or lactating women
  • preoperative uncontrolled infection
  • the researchers believe the patients should not enrolled in

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    R-TME

    R-TaTME

    Arm Description

    Robotic total mesentery excision surgery for rectal cancer.

    Robotic transanal total mesentery excision surgery for rectal cancer.

    Outcomes

    Primary Outcome Measures

    Positive rate of circumferential resection margin (CRM) of the specimens
    Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while >1mm is negative.

    Secondary Outcome Measures

    The grade score of the specimens integrity
    the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see >5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.
    The distance between lower tumor margin and the lower reaction margin
    the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.
    postoperative hospital stay
    recovery information.
    disease free survival rate
    the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
    overall survival rate
    the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
    the rate of postoperative complications
    preoperative safety containing operation information, complication information.

    Full Information

    First Posted
    January 24, 2018
    Last Updated
    January 30, 2018
    Sponsor
    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03422835
    Brief Title
    Robotic Assisted Transanal Total Mesorectal Excision Surgery for Rectal Cancer in Low Site
    Official Title
    A Prospective Cohort Study of Robotic Transanal Total Mesentery Excision Versus Conventional Robotic Surgery for Rectal Cancer in Low Site
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2018 (Anticipated)
    Primary Completion Date
    December 30, 2020 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To investigates the feasibility, practicability, safety and subjective as well as functional outcome of Robotic transanal total mesentery excision for rectal cancer in low site.
    Detailed Description
    Transanal total mesorectal excision (TaTME) may offer a better way to achieve radical resection and functional protection for lower rectal cancer, which have been regarded as challenging situations in rectal cancer surgery. However, the narrow angle and limited space of the operation restrict the wide spread of this technique. Da Vinci robotic system has achieved good results in rectal cancer surgery. Robotics may help to overcome technical difficulties in TaTME. The purpose of this study was to explore the availability of Da Vinci robotic-assisted transanal total mesorectal excision(R-TaTME) This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of Robotic transanal total mesentery excision for rectal cancer in low site.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Neoplasms
    Keywords
    transanal surgery, robotic surgery, total mesorectal excision

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    R-TME
    Arm Type
    Active Comparator
    Arm Description
    Robotic total mesentery excision surgery for rectal cancer.
    Arm Title
    R-TaTME
    Arm Type
    Experimental
    Arm Description
    Robotic transanal total mesentery excision surgery for rectal cancer.
    Intervention Type
    Procedure
    Intervention Name(s)
    R-TME
    Intervention Description
    Conventional Robotic Total Mesentery Excision
    Intervention Type
    Procedure
    Intervention Name(s)
    R-TaTME
    Intervention Description
    Robotic Transanal Total Mesentery Excision
    Primary Outcome Measure Information:
    Title
    Positive rate of circumferential resection margin (CRM) of the specimens
    Description
    Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while >1mm is negative.
    Time Frame
    10 days after surgery
    Secondary Outcome Measure Information:
    Title
    The grade score of the specimens integrity
    Description
    the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see >5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.
    Time Frame
    10 days after surgery
    Title
    The distance between lower tumor margin and the lower reaction margin
    Description
    the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.
    Time Frame
    10 days after surgery
    Title
    postoperative hospital stay
    Description
    recovery information.
    Time Frame
    3 years after surgery
    Title
    disease free survival rate
    Description
    the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
    Time Frame
    3 years after surgery
    Title
    overall survival rate
    Description
    the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
    Time Frame
    3 years after surgery
    Title
    the rate of postoperative complications
    Description
    preoperative safety containing operation information, complication information.
    Time Frame
    30 days after surgery
    Other Pre-specified Outcome Measures:
    Title
    defecating functional outcomes
    Description
    Wexner scale
    Time Frame
    3 years after surgery
    Title
    sexual functional outcomes
    Description
    We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (International Index of Erectile Function (IIEF)
    Time Frame
    2 years after surgery
    Title
    Quality of life outcomes evaluation
    Description
    We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (Short Form-36 (SF36).
    Time Frame
    2 years rafter surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: adenocarcinoma of the rectum by biopsy the lower edge of the tumor from the anal margin less than 8cm according to MRI or rigid endoscopy tumor diameter less than 4cm baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7) tolerable to surgery be able to understand and willing to participate in this trial with signature Exclusion Criteria: history of malignant colorectal neoplasia recent diagnosis with other malignancies patients requiring emergency surgery such as obstruction，perforation and bleeding tumor involving adjacent organs, anal sphincter, or levator ani muscle muti-focal colorectal cancer preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence history of inflammatory bowel disease or familial adenomatous polyposis participating in other clinical trails History of pelvic radiation BMI > 40 Large uterine fibroids can not tolerate the surgery history of serious mental illness pregnancy or lactating women preoperative uncontrolled infection the researchers believe the patients should not enrolled in
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    fan li, MD.
    Phone
    +86 023 68757958
    Email
    levinecq@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    fan li, MD.
    Organizational Affiliation
    Daping Hospital, Third Military Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    6751457
    Citation
    Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019.
    Results Reference
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    PubMed Identifier
    28549014
    Citation
    Kim MJ, Park SC, Park JW, Chang HJ, Kim DY, Nam BH, Sohn DK, Oh JH. Robot-assisted Versus Laparoscopic Surgery for Rectal Cancer: A Phase II Open Label Prospective Randomized Controlled Trial. Ann Surg. 2018 Feb;267(2):243-251. doi: 10.1097/SLA.0000000000002321.
    Results Reference
    background
    PubMed Identifier
    27744632
    Citation
    Kuo LJ, Ngu JC, Tong YS, Chen CC. Combined robotic transanal total mesorectal excision (R-taTME) and single-site plus one-port (R-SSPO) technique for ultra-low rectal surgery-initial experience with a new operation approach. Int J Colorectal Dis. 2017 Feb;32(2):249-254. doi: 10.1007/s00384-016-2686-3. Epub 2016 Oct 15.
    Results Reference
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    PubMed Identifier
    26620555
    Citation
    Wang Y, Liu R, Zhang Z, Xue Q, Yan J, Yu J, Liu H, Zhao L, Mou T, Deng H, Li G. A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial. Trials. 2015 Nov 30;16:539. doi: 10.1186/s13063-015-1067-5.
    Results Reference
    background
    PubMed Identifier
    26342816
    Citation
    Odermatt M, Flashman K, Khan J, Parvaiz A. Laparoscopic-assisted abdominoperineal resection for low rectal cancer provides a shorter length of hospital stay while not affecting the recurrence or survival: a propensity score-matched analysis. Surg Today. 2016 Jul;46(7):798-806. doi: 10.1007/s00595-015-1244-x. Epub 2015 Sep 5.
    Results Reference
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    PubMed Identifier
    22936590
    Citation
    Zhang H, Zhang YS, Jin XW, Li MZ, Fan JS, Yang ZH. Transanal single-port laparoscopic total mesorectal excision in the treatment of rectal cancer. Tech Coloproctol. 2013 Feb;17(1):117-23. doi: 10.1007/s10151-012-0882-x. Epub 2012 Aug 31.
    Results Reference
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    PubMed Identifier
    23519489
    Citation
    de Lacy AM, Rattner DW, Adelsdorfer C, Tasende MM, Fernandez M, Delgado S, Sylla P, Martinez-Palli G. Transanal natural orifice transluminal endoscopic surgery (NOTES) rectal resection: "down-to-up" total mesorectal excision (TME)--short-term outcomes in the first 20 cases. Surg Endosc. 2013 Sep;27(9):3165-72. doi: 10.1007/s00464-013-2872-0. Epub 2013 Mar 22.
    Results Reference
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    PubMed Identifier
    25185463
    Citation
    Fernandez-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Diaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865.
    Results Reference
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