Robotic Top-down Intersphincteric Resection

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961969
• Other study ID #: 202107066RINA
• Status: Recruiting
• Start date: February 21, 2022
• Est. completion date: August 2025

Study information

• Verified date: September 2022
• Source: National Taiwan University Hospital
• Contact: Jin-Tung LIANG, PhD
• Phone: +886-9-72-651432
• Email: jintung[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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 ? to ? 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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Robotic surgery
Patients with rectal cancer. Patients will undergo robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis

Locations

Country	Name	City	State
Taiwan	Jin-Tung LIANG	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Circumferential resection margin (CRM)	The radicality of CRM will be evaluated by a pathologist for any tumor invasion	About one week
Secondary	Distal and proximal resection margin	The radicality of distal and proximal margin	About one week
Secondary	Length of operation time	The duration between skin incision and wound dressing	Through the completion of surgery, an average of 5 hours
Secondary	Length of postoperative ileus	One of the most common postoperative complication	30 days
Secondary	Hospitalization	The total days of stay in hospital during postoperative period	After patients' discharge from hospital, an average of 7 days
Secondary	Degree of postoperative pain	The visual analogue scale	After patients' discharge from hospital, an average of 7 days
Secondary	Intraoperative complications	Any adverse effect will be recorded.	Within 5 hours
Secondary	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
Secondary	Acute anastomotic leakage	The presence of clinical features of peritonitis and bowel contents in the drainage during hospitalization.	30 days
Secondary	Chronic anastomotic leakage	a defect at the anastomotic site that results in a communication with the bowel lumen.	6 months
Secondary	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
Secondary	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