Robotic Top-down Intersphincteric Resection

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

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Robotic surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Jin-Tung LIANG, PhD; Phone Number: +886-9-72-651432; Email: jintung@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 886
    • Recruiting
    • Jin-Tung LIANG
    • Contact: Jin-Tung LIANG, PhD; Phone Number: +886-9-72-651432; Email: jintung@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients diagnosed as rectal cancer and met with the above inclusion and exclusion criteria will be recruited.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection; Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis	Procedure: Robotic surgery; Patients with rectal cancer.; Patients will undergo robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Jin-Tung LIANG, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 9, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Rectal cancer; Intersphincteric resection (ISR); Transabdominal ISR; Top-down ISR; Transanal ISR
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 202107066RINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No