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NCT05933785 Clinical Trial

the Value of Transanal Endoscopic ISR

Rectal Cancer Clinical Trial

Official title:
The Value of Transanal Endoscopic Intersphincteric Resection (taE-ISR) in Extreme Anal Preservation in Ultra-low Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05933785
Other study ID # taE-ISR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2018
Est. completion date May 30, 2023

Study information
Verified date March 2024
Source Shanghai Minimally Invasive Surgery Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Intersphincteric resection (ISR) technique is an alternative for anal preservation in ultra-low rectal cancer. The transanal total mesorectal excision (TaTME) technique might compensate for the deficiencies of ISR in terms of tumor spillage and poor surgical field exposure. Thus, the investigators perform ISR through a transanal endoscopic approach (taE-ISR), seeking to evaluate the value of this innovative technique in anal preservation in ultra-low rectal cancer.

Recruitment information / eligibility
Status Completed
Enrollment 260
Est. completion date May 30, 2023
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 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 - preoperative stage as (y) cT1-3N0-2M0 - lower margin of the tumor less than 5cm from the anus - tumor diameter =5cm 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

Procedure:
• transanal endoscopic ISR
perform ISR using laparoscopy through transanal port

Locations
Country Name City State
China Ruijin Hospital 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 anal preservation rate No conversion to APR and closure was closed within 1 year after surgery 1 year after sugery
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
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