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NCT05108753 Clinical Trial

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

Rectal Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05108753
Other study ID # MISC-TaTME-RETRO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date September 30, 2021

Study information
Verified date November 2021
Source Shanghai Minimally Invasive Surgery Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 175
Est. completion date September 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Procedure/Surgery
Transanal Total Mesorectal Excision

Locations
Country Name City State
China Ruijin Hospital Shanghai Shanghai
China Shanghai Minimally Invasive Surgery Center Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Minimally Invasive Surgery Center

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of anastomotic leakage according to the International Rectal Cancer Study Group thirty days after surgery
Secondary incidence of Defecation disorders A Wexner score >10 indicated the existence of defecation dysfunction 6 months after surgery
Secondary 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
Secondary 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
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