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Trial Title:
Robotic Top-down Intersphincteric Resection
NCT ID:
NCT05961969
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Intersphincteric resection (ISR)
Transabdominal ISR
Top-down ISR
Transanal ISR
Rectal cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Robotic surgery
Description:
1. Patients with rectal cancer.
2. Patients will undergo robotic Transabdominal Top-down Intersphincteric Resection
with Double-stapling Coloanal Anastomosis
Arm group label:
Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection
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.
Criteria for eligibility:
Study pop:
The patients diagnosed as rectal cancer and met with the above inclusion and exclusion
criteria will be recruited.
Sampling method:
Non-Probability Sample
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)
Gender:
All
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jin-Tung LIANG
Address:
City:
Taipei
Zip:
886
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Jin-Tung LIANG, PhD
Phone:
+886-9-72-651432
Email:
jintung@ntu.edu.tw
Start date:
February 21, 2022
Completion date:
August 2025
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05961969
