the Value of Transanal Endoscopic ISR

Shanghai Minimally Invasive Surgery Center

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: transanal endoscopic ISR

Study type: Observational

Funder types: Other

Identifiers

NCT05933785

taE-ISR

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

260 participants in 2 patient groups

transanal endoscopic ISR

Treatment:

Procedure: transanal endoscopic ISR

traditional ISR