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NCT Number: NCT05961969

Robotic Top-down Intersphincteric Resection

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

Recruiting

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Robotic surgery

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

Primary outcomes

  1. Completion of transabdominal ISR

    Time frame: About one week

    • 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.

Secondary outcomes

  1. Circumferential resection margin (CRM)

    Time frame: About one week

    The radicality of CRM will be evaluated by a pathologist for any tumor invasion

  2. Distal and proximal resection margin

    Time frame: About one week

    The radicality of distal and proximal margin

  3. Length of operation time

    Time frame: Through the completion of surgery, an average of 5 hours

    The duration between skin incision and wound dressing

  4. Length of postoperative ileus

    Time frame: 30 days

    One of the most common postoperative complication

  5. Hospitalization

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

    The total days of stay in hospital during postoperative period

  6. Degree of postoperative pain

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

    The visual analogue scale

  7. Intraoperative complications

    Time frame: Within 5 hours

    Any adverse effect will be recorded.

  8. The wound infection

    Time frame: 30 days

    the presence of thin discharge or local abscess in the operative wound, followed by the confirmation with Gram stains or bacterial cultures.

  9. Acute anastomotic leakage

    Time frame: 30 days

    The presence of clinical features of peritonitis and bowel contents in the drainage during hospitalization.

  10. Chronic anastomotic leakage

    Time frame: 6 months

    a defect at the anastomotic site that results in a communication with the bowel lumen.

  11. Questionnaire to assess disability

    Time frame: 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.

  12. Fecal incontinence

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jin-Tung LIANG, PhD

CONTACT

[email protected]

+886-9-72-651432

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2023
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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