Robotic Top-down Intersphincteric Resection

NCT ID: NCT05961969

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2025-08-31

Brief Summary

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

Detailed Description

The intersphincteric resection (ISR) for the treatment of distal rectal cancer has been a complex two-step surgical procedure consisting of transabdominal mobilization of the anorectum and transanal bowel resection with handsewn coloanal anastomosis. The availability of robotic systems may facilitate the transabdominal approach, simplify the surgical procedures, and achieve better anorectal function for patients with distal rectal cancer requiring an ISR. Consecutive 40 patients with distal rectal cancer undergoing the single-step robotic transabdominal ISR with the intent-to-treat principle will be recruited. The risk factors for a failed transabdominal ISR were identified from the prospectively maintained clinicopathologic data using univariate and multivariate analysis. The surgical outcomes, the anorectal function, and the tumor recurrence were compared between patients with a successful or failed robotic transabdominal ISR. The investigators believe that the present project can facilitate the development of the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer in our hospital and even in Taiwan.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection

Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis

Robotic surgery

Intervention Type: PROCEDURE

1. Patients with rectal cancer.

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

Interventions

Robotic surgery

1. Patients with rectal cancer.

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin-Tung LIANG, PhD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

Jin-Tung LIANG

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jin-Tung LIANG, PhD

Role: CONTACT

jintung@ntu.edu.tw

+886-9-72-651432

Facility Contacts

Jin-Tung LIANG, PhD

Role: primary

jintung@ntu.edu.tw

+886-9-72-651432

Other Identifiers

202107066RINA

Identifier Type: -

Identifier Source: org_study_id