Short-term Outcomes of Transanal Total Mesorectal Excision With Structured Training Curriculums in China

Short-term Outcomes of Transanal Total Mesorectal Excision With Structured Training Curriculums in China: Retrospective Study of the First Twenty-five Cases in Seven High-volume Centers

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Other: Procedure/Surgery

• Study Type: Observational
• Enrollment (Actual): 175

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Minimally Invasive Surgery Center
  • Shanghai
    • Shanghai, Shanghai, China, 200020
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

rectal cancer

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; 5 patients underwent TaTME under proctoring	Other: Procedure/Surgery; Transanal Total Mesorectal Excision
Group 2; the first 10 patients underwent TaTME without proctoring	Other: Procedure/Surgery; Transanal Total Mesorectal Excision
Group 3; the second 10 patients underwent TaTME without proctoring	Other: Procedure/Surgery; Transanal Total Mesorectal Excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of anastomotic leakage	according to the International Rectal Cancer Study Group	thirty days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of Defecation disorders	A Wexner score >10 indicated the existence of defecation dysfunction	6 months after surgery
incidence of positive distal resection margin	A positive distal resection margin (DRM) was diagnosed with the presence of tumor cells within 1mm from the DRM	30 days after surgery
incidence of positivecircumferential resection margin	The positive circumferential resection margin (CRM) was defined as the presence of tumor cells within 1 mm from the CRM	30 days after surgery

Collaborators and Investigators

• Sponsor: Shanghai Minimally Invasive Surgery Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): April 30, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (ACTUAL): November 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: MISC-TaTME-RETRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No