the Value of Transanal Endoscopic ISR

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: transanal endoscopic ISR

• Registration Number: NCT05933785
• Lead Sponsor: Shanghai Minimally Invasive Surgery Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Primary Completion: 2021-06-30
• Study Completion: 2023-05-30
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
transanal endoscopic ISR	transanal endoscopic ISR	-

Primary Outcome Measures

Name	Time	Method
anal preservation rate	1 year after sugery	No conversion to APR and closure was closed within 1 year after surgery

Secondary Outcome Measures

Name	Time	Method
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)

Shanghai Minimally Invasive Surgery Center; 🇨🇳 Shanghai, China

Ruijin Hospital; 🇨🇳 Shanghai, China