RecruitingNCT05961969

Robotic Top-down Intersphincteric Resection

A Feasibility Study of Robotic Transabdominal Top-down Intersphincteric Resection With Double-stapling Coloanal Anastomosis for Distal Rectal Cancer

Sponsor

National Taiwan University Hospital

Enrollment

40 participants

Start Date

Feb 21, 2022

Study Type

OBSERVATIONAL

Conditions

Colorectal, Cancer

Summary

The present study is to develop the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer.

Eligibility

Min Age: 20 YearsMax Age: 75 Years

Inclusion Criteria5

cT1-3 or yT 1-3 rectal adenocarcinoma whose low border was located below the anorectal sling (4 cm from anal verge), in which the required surgery meets the definition of ISR;
Clinically Tumor-Node-Metastasis (TNM) stage I-III rectal adenocarcinoma;
Curative and elective surgery;
American Society of Anesthesiology (ASA) class Ⅰ to Ⅲ patients;
Age between 20 and 75 years.

Exclusion Criteria6

cT4 adenocarcinoma, i.e., the rectal cancer invaded to external sphincter or adjacent pelvic organs;
Evidence of distant metastasis;
Primary tumor mass≧8 cm in diameter;
Morbidly obese patients, i.e., body mass index (BMI) ≧ 40 kg/m2 ;
Previous major surgery of low upper abdomen;
The adenocarcinoma has invaded to lateral pelvic side wall requiring a lateral pelvic lymph node dissection. (7) Patients with poor anorectal function (Wexner incontinence Score≧ 10)

Interventions

PROCEDURERobotic surgery

1. Patients with rectal cancer. 2. Patients will undergo robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis