Jin-Tung LIANG
Taipei, 886, Taiwan
Location status: Recruiting
NCT Number: NCT05961969
The present study is to develop the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer.
Interested in participating?
Request Info20 year–75 year
All sexes
Observational
Taipei, 886, Taiwan
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: About one week
Time frame: About one week
The radicality of CRM will be evaluated by a pathologist for any tumor invasion
Time frame: About one week
The radicality of distal and proximal margin
Time frame: Through the completion of surgery, an average of 5 hours
The duration between skin incision and wound dressing
Time frame: 30 days
One of the most common postoperative complication
Time frame: After patients' discharge from hospital, an average of 7 days
The total days of stay in hospital during postoperative period
Time frame: After patients' discharge from hospital, an average of 7 days
The visual analogue scale
Time frame: Within 5 hours
Any adverse effect will be recorded.
Time frame: 30 days
the presence of thin discharge or local abscess in the operative wound, followed by the confirmation with Gram stains or bacterial cultures.
Time frame: 30 days
The presence of clinical features of peritonitis and bowel contents in the drainage during hospitalization.
Time frame: 6 months
a defect at the anastomotic site that results in a communication with the bowel lumen.
Time frame: 6 months
Standardized questionnaire was given to patients to assess disability that included the number of days until return to partial activity, full activity, and work on the basis of their subjective responses.
Time frame: 6 months
Wexner score, also known as Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) is a fecal incontinence score from 0-20; where 0 is perfect continence and 20 is complete incontinence.
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
A Feasibility Study of Robotic Transabdominal Top-down Intersphincteric Resection With Double-stapling Coloanal Anastomosis for Distal Rectal Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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