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
About this trial
This is an interventional treatment trial for Rectal Neoplasms focused on measuring transanal surgery, robotic surgery, total mesorectal excision
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
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
NCT ID
NCT03422835
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
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
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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
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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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Robotic Assisted Transanal Total Mesorectal Excision Surgery for Rectal Cancer in Low Site
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