Robotic Top-down Intersphincteric Resection

NCT05961969 | Recruiting

• 1 other identifier: 202107066RINA
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Intersphincteric resection (ISR); Transabdominal ISR; Top-down ISR; Transanal ISR; Rectal cancer

Outcome Measures

Primary Outcomes (1)

• Completion of transabdominal ISR

  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.

  About one week

Secondary Outcomes (12)

• Circumferential resection margin (CRM)

  About one week

• Distal and proximal resection margin

  About one week

• Length of operation time

  Through the completion of surgery, an average of 5 hours

• Length of postoperative ileus

  30 days

• Hospitalization

  After patients' discharge from hospital, an average of 7 days

Study Arms (1)

Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection

Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis

Procedure: Robotic surgery

Interventions

Robotic surgery PROCEDURE

1. Patients with rectal cancer. 2. Patients will undergo robotic Transabdominal Top-down Intersphincteric Resection with Double-stapling Coloanal Anastomosis

Patients undergoing robotic Transabdominal Top-down Intersphincteric Resection

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Jin-Tung LIANG

Taipei, 886, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Jin-Tung LIANG, PhD

  National Taiwan University Hospital

  STUDY DIRECTOR

Central Study Contacts

Jin-Tung LIANG, PhD

CONTACT

+886-9-72-651432; jintung@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: July 27, 2023
• Study Start: February 21, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

TW (1)