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

Completed

• Conditions: Rectal Cancer
• Interventions: Other: Procedure/Surgery

• Registration Number: NCT05108753
• Lead Sponsor: Shanghai Minimally Invasive Surgery Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-09-30
• Study First Submitted: 2021-10-25
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-03
• Last Update Submitted: 2021-11-03
• Study First Posted: 2021-11-05
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Procedure/Surgery	5 patients underwent TaTME under proctoring
Group 2	Procedure/Surgery	the first 10 patients underwent TaTME without proctoring
Group 3	Procedure/Surgery	the second 10 patients underwent TaTME without proctoring

Primary Outcome Measures

Name	Time	Method
incidence of anastomotic leakage	thirty days after surgery	according to the International Rectal Cancer Study Group

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Minimally Invasive Surgery Center; 🇨🇳 Shanghai, China