Robotic surgery for distal rectal cancer treatment
A Feasibility Study of Robotic Transabdominal Top-down Intersphincteric Resection With Double-stapling Coloanal Anastomosis for Distal Rectal Cancer
This study is testing a new robotic surgery method for treating distal rectal cancer to see if it can make the procedure easier and improve recovery for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05961969 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a novel robotic surgical technique for intersphincteric resection (ISR) in patients with distal rectal cancer. It involves a single-step robotic transabdominal ISR, which simplifies the surgical procedure compared to traditional methods. The study will recruit 40 patients and analyze surgical outcomes, anorectal function, and tumor recurrence rates. The goal is to enhance surgical quality and improve patient outcomes in Taiwan.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 75 with cT1-3 or yT1-3 rectal adenocarcinoma located below the anorectal sling.
Not a fit: Patients with cT4 adenocarcinoma, distant metastasis, or poor anorectal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and better anorectal function for patients with distal rectal cancer.
How similar studies have performed: While the use of robotic surgery in colorectal procedures is gaining traction, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Taipei
- Jin-Tung LIANG — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Jin-Tung LIANG, PhD
- Email: jintung@ntu.edu.tw
- Phone: +886-9-72-651432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.