Robotic Top-down Intersphincteric Resection

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Robotic surgery


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection<br>Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis | Procedure: Robotic surgery<br>* Patients with rectal cancer. Patients will undergo robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of transabdominal ISR | The total mobilization and transection of anorectum was performed in the transabdominal down sequence, followed by the double-stapling technique for the coloanal anastomosis; the proximal and distal stapled tissue doughnuts recovered from EEA device were intact; A variable length of muscular cuff of proximal internal anal sphincter was removed with a TME specimen; To define a successful transabdominal total ISR, besides the above-mentioned three criteria, the anastomotic site should be checked by immediate anoscopy to confirm the stapling line is approximately at the level of anal intersphincteric groove. | About one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circumferential resection margin (CRM) | The radicality of CRM will be evaluated by a pathologist for any tumor invasion | About one week | 
| Distal and proximal resection margin | The radicality of distal and proximal margin | About one week | 
| Length of operation time | The duration between skin incision and wound dressing | Through the completion of surgery, an average of 5 hours | 
| Length of postoperative ileus | One of the most common postoperative complication | 30 days | 
| Hospitalization | The total days of stay in hospital during postoperative period | After patients' discharge from hospital, an average of 7 days | 
| Degree of postoperative pain | The visual analogue scale | After patients' discharge from hospital, an average of 7 days | 
| Intraoperative complications | Any adverse effect will be recorded. | Within 5 hours | 
| The wound infection | the presence of thin discharge or local abscess in the operative wound, followed by the confirmation with Gram stains or bacterial cultures. | 30 days | 
| Acute anastomotic leakage | The presence of clinical features of peritonitis and bowel contents in the drainage during hospitalization. | 30 days | 
| Chronic anastomotic leakage | a defect at the anastomotic site that results in a communication with the bowel lumen. | 6 months | 
| Questionnaire to assess disability | 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. | 6 months | 
| Fecal incontinence | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intersphincteric resection (ISR), Transabdominal ISR, Top-down ISR, Transanal ISR, Rectal cancer