NCT03413930

Brief Summary

This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision（LaTME）.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

January 22, 2018

Last Update Submit

February 12, 2020

Conditions

Rectal Cancer

Keywords

TaTMERectal cancerLaparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

  • Circumferential resection margin (CRM)

    Positive rate of circumferential resection margin (pathological assessment)

    14 days after surgery

Secondary Outcomes (11)

  • Completeness of mesorectum

    14 days after surgery

  • Lymph node detection

    14 days after surgery

  • Distal safety margin

    14 days after surgery

  • Operative time

    Intraoperative

  • Intraoperative blood loss

    Intraoperative

  • +6 more secondary outcomes

Study Arms (2)

TaTME

EXPERIMENTAL

Patients with mid or low rectal cancer undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA）

Procedure: Transanal total mesorectal excision

LaTME

ACTIVE COMPARATOR

Patients with mid or low rectal cancer undergo laparoscopic total mesorectal excision.

Procedure: Laparoscopic total mesorectal excision

Interventions

Transanal total mesorectal excisionPROCEDURE

Patients undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA）

TaTME
Laparoscopic total mesorectal excisionPROCEDURE

Patients undergo Laparoscopic total mesorectal excision.

LaTME

Eligibility Criteria

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

You may qualify if:

  • years \< age \< 80 years
  • Body mass index (BMI) \<30 kg/m2
  • Tumor located in mid and low rectum ( the lower border of the tumor is located distal to the peritoneal reflection)
  • Pathological rectal carcinoma
  • Clinically diagnosed cT1-3N0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history
  • Tumor size of 5 cm or less
  • ECOG score is 0-1
  • ASA score is Ⅰ-Ⅲ
  • Informed consent

You may not qualify if:

  • Requiring a Mile's procedure
  • Fecal incontinence
  • History of inflammatory bowel disease
  • Pregnant woman or lactating woman
  • Severe mental disease
  • Intolerance of surgery for severe comorbidities
  • Previous abdominal surgery
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by rectal cancer
  • Requirement of simultaneous surgery for other disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital North

Shanghai, Shanghai Municipality, 201821, China

Location

Related Publications (3)

  • Simillis C, Hompes R, Penna M, Rasheed S, Tekkis PP. A systematic review of transanal total mesorectal excision: is this the future of rectal cancer surgery? Colorectal Dis. 2016 Jan;18(1):19-36. doi: 10.1111/codi.13151.

    PMID: 26466751BACKGROUND

  • 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

  • Deijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4.

    PMID: 26537907BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yimei Jiang, MD

    Ruijin Hospitla North

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physicion

Study Record Dates

First Submitted

January 22, 2018

First Posted

January 29, 2018

Study Start

June 1, 2019

Primary Completion

March 1, 2021

Study Completion

March 1, 2026

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)