Robotic Top-down Intersphincteric Resection

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Procedure: Robotic surgery

• Registration Number: NCT05961969
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Study Timeline

• Study Start: 2022-02-21
• Status Verified: 2022-09
• Study First Submitted: 2023-07-09
• Study First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection	Robotic surgery	Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis

Primary Outcome Measures

Name	Time	Method
Completion of transabdominal ISR	About one week	1. The total mobilization and transection of anorectum was performed in the transabdominal down sequence, followed by the double-stapling technique for the coloanal anastomosis; 2. the proximal and distal stapled tissue doughnuts recovered from EEA device were intact; 3. A variable length of muscular cuff of proximal internal anal sphincter was removed with a TME specimen; 4. 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jin-Tung LIANG; 🇨🇳 Taipei, Taiwan