NCT05108753

Brief Summary

Transanal total mesorectal excision (TaTME) is an alternative for mid-low rectal cancer. In China, this procedure has been performed in high-volume centers with structured training curriculums. This study aimed to evaluate the short-term outcomes during the initial implementation of the TaTME procedure in high-volume centers who followed structured training curriculums in China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

February 1, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

4.2 years

First QC Date

October 25, 2021

Last Update Submit

November 3, 2021

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • incidence of anastomotic leakage

    according to the International Rectal Cancer Study Group

    thirty days after surgery

Secondary Outcomes (3)

  • incidence of Defecation disorders

    6 months after surgery

  • incidence of positive distal resection margin

    30 days after surgery

  • incidence of positivecircumferential resection margin

    30 days after surgery

Study Arms (3)

Group 1

5 patients underwent TaTME under proctoring

Other: Procedure/Surgery

Group 2

the first 10 patients underwent TaTME without proctoring

Other: Procedure/Surgery

Group 3

the second 10 patients underwent TaTME without proctoring

Other: Procedure/Surgery

Interventions

Procedure/SurgeryOTHER

Transanal Total Mesorectal Excision

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

rectal cancer

You may qualify if:

  • Age between 18 and 75 years
  • American Society of Anesthesiologists (ASA) score I to III
  • A biopsy proven histological diagnosis of rectal carcinoma
  • Undergoing transanal total mesorectal excision

You may not qualify if:

  • Pregnant or lactating women
  • Synchronous rectal carcinoma
  • History of colorectal cancer or other malignant tumors
  • Clinical evidence of metastasis
  • Emergency procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

Location

Shanghai Minimally Invasive Surgery Center

Shanghai, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 5, 2021

Study Start

February 1, 2017

Primary Completion

April 30, 2021

Study Completion

September 30, 2021

Last Updated

November 5, 2021

Record last verified: 2021-11

Locations

CN(2)