NCT03359616

Brief Summary

Total mesorectal excision (TME) has been prevailingly accepted as a crucial surgical intervention within the latest oncological therapeutic regime for mid-low rectal cancer. However, surgical dissection under the restricted pelvic anatomical structure, added by obesity and many other general factors, remains challenging for classical open and laparoscopic patterns, particularly in male cases. The introduction of transanal total mesorectal excision (TaTME) offers an optimal pattern for the surgical resection of mid-low rectal cancer, circumventing the conventional anatomical limits while bringing forward considerable advantages by direct dissection. Noteworthy, the surgical techniques of TaTME is initially established, with the mortality/morbidity and the oncological safety unverified. The studies that focus on the comparison between TaTME and laparoscopic TME (LaTME) remain sparse. Therefore, the features of TaTME, both in short and long terms, await further consolidation by clinical trials. Herein, this single centered, interventional study protocol is established to collect initial clinical data on both the safety and efficacy of the TaTME in comparison with LaTME in East Chinese patients with mid-low rectal cancer.

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
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

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

November 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

November 26, 2017

Last Update Submit

November 30, 2017

Conditions

Rectal CancerSurgery

Keywords

rectal cancerlaparoscopic surgerytotal mesorectal excisiontransanal surgery

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival (DFS)

    3-year DFS

    3-years

Secondary Outcomes (6)

  • Overall survival (OS)

    3-years

  • mesorectal completeness

    3-years

  • positive circumferential resection margin

    3-years

  • number of retrieved lymph nodes

    3-years

  • morbidity rate

    3-years

  • +1 more secondary outcomes

Study Arms (2)

transanal total mesorectal excision

EXPERIMENTAL

Transanally, the rectum is mobilized through the mesorectal plane according to the TME principles, assisted by the transanal surgical platform (Transanally curable surgical resection).

Procedure: Transanally curable surgical resection

laparoscopic total mesorectal excision

ACTIVE COMPARATOR

By standard laparoscopic techniques, the rectal cancer will be resected by the conventional laparoscopic TME (LaTME).

Procedure: Laparoscopic total mesorectal excision

Interventions

Transanally curable surgical resectionPROCEDURE

Transanally, the rectal cancer will be mobilized with oncological principle of total mesorectal excision

transanal total mesorectal excision
Laparoscopic total mesorectal excisionPROCEDURE

Conventionally by laparoscopic surgery, the rectal cancer will be mobilized with oncological principle of total mesorectal excision

laparoscopic total mesorectal excision

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rectal adenocarcinoma validated by pathologists, pathological estimated stage II-III;
  • Mid and low rectal tumor sites, parameter less than 5cm, below the level of peritoneal reflection and verified by MRI, distance to anus less than 7 cm;
  • Curative rectal cancer surgery;
  • No evidence of distance metastasis lesions;
  • T1-3, N0-2, with or without neoadjuvant therapeutic history;
  • Applied to laparoscopic surgery;
  • Absent of previous malignancy-treated history
  • No gender restriction, age between 18 and 75, Body Mass Index less than 32;
  • Approved by multiple disciplinary teamwork therapeutic group
  • Consent by the patient and the family.

You may not qualify if:

  • Mile's surgery is additionally required;
  • Tumor invasion is validated on adjacent organs, such as prostate;
  • Recurrent rectal cancer, require secondary surgical interventions;
  • Previous history of malignant diseases or inflammatory bowel diseases within recent five years;
  • Emergent surgery accompanied by bowel obstruction or intestinal perforation;
  • Previous history of colorectal surgery, unnatural anatomical structure;
  • Contraindication to general anesthesia (class IV or V in American Society of Anesthesiologists (ASA), or Eastern Cooperative Oncology Group (ECOG) score \>=2)
  • Pregnant or breast-feeding patients;
  • Mental disorder validated by psychiatrists.
  • Uncontrolled infectious diseases;
  • Participants within other related clinical trials that may influence the conclusion of this trial;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Motson RW, Whiteford MH, Hompes R, Albert M, Miles WF; Expert Group. Current status of trans-anal total mesorectal excision (TaTME) following the Second International Consensus Conference. Colorectal Dis. 2016 Jan;18(1):13-8. doi: 10.1111/codi.13131.

    PMID: 26400670BACKGROUND

  • Bulut O, Levic K, Hesselfeldt P, Bulow S. The outcome of rectal cancer after early salvage TME following TEM compared with primary TME: a case-matched study. Tech Coloproctol. 2014 Jan;18(1):83-4. doi: 10.1007/s10151-013-1083-y. Epub 2013 Nov 6. No abstract available.

    PMID: 24197900BACKGROUND

  • Martin-Perez B, Andrade-Ribeiro GD, Hunter L, Atallah S. A systematic review of transanal minimally invasive surgery (TAMIS) from 2010 to 2013. Tech Coloproctol. 2014 Sep;18(9):775-88. doi: 10.1007/s10151-014-1148-6. Epub 2014 May 7.

    PMID: 24848524BACKGROUND

  • 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: 25185463RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Minhua Zheng, M.D., PhD.

    MISC, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University

    STUDY DIRECTOR

Central Study Contacts

Minhua Zheng, M.D., PhD.

CONTACT

0086-13564119545zmhtiger@yeah.com

Jing Sun, M.D., PhD.

CONTACT

0086-13524284622sj11788@rjh.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2017

First Posted

December 2, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

December 2, 2017

Record last verified: 2017-11