NCT03422835

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2018

Longer than P75 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 6, 2018

Status Verified

January 1, 2018

Enrollment Period

2.9 years

First QC Date

January 24, 2018

Last Update Submit

January 30, 2018

Conditions

Rectal Neoplasms

Keywords

transanal surgeryrobotic surgerytotal mesorectal excision

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 days after surgery

Secondary Outcomes (6)

  • The grade score of the specimens integrity

    10 days after surgery

  • The distance between lower tumor margin and the lower reaction margin

    10 days after surgery

  • postoperative hospital stay

    3 years after surgery

  • disease free survival rate

    3 years after surgery

  • overall survival rate

    3 years after surgery

  • +1 more secondary outcomes

Other Outcomes (3)

  • defecating functional outcomes

    3 years after surgery

  • sexual functional outcomes

    2 years after surgery

  • Quality of life outcomes evaluation

    2 years rafter surgery

Study Arms (2)

R-TME

ACTIVE COMPARATOR

Robotic total mesentery excision surgery for rectal cancer.

Procedure: R-TME

R-TaTME

EXPERIMENTAL

Robotic transanal total mesentery excision surgery for rectal cancer.

Procedure: R-TaTME

Interventions

R-TMEPROCEDURE

Conventional Robotic Total Mesentery Excision

R-TME
R-TaTMEPROCEDURE

Robotic Transanal Total Mesentery Excision

R-TaTME

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 6751457BACKGROUND

  • 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.

    PMID: 28549014BACKGROUND

  • 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.

    PMID: 27744632BACKGROUND

  • 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.

    PMID: 26620555BACKGROUND

  • 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.

    PMID: 26342816BACKGROUND

  • 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.

    PMID: 22936590BACKGROUND

  • 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.

    PMID: 23519489BACKGROUND

  • 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.

    PMID: 25185463BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • fan li, MD.

    Daping Hospital, Third Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

fan li, MD.

CONTACT

+86 023 68757958levinecq@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 6, 2018

Study Start

February 15, 2018

Primary Completion

December 30, 2020

Study Completion

December 30, 2023

Last Updated

February 6, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share