Clinical trial NCT05961969: Robotic Top-down Intersphincteric Resection
Official title: A Feasibility Study of Robotic Transabdominal Top-down Intersphincteric Resection With Double-stapling Coloanal Anastomosis for Distal Rectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Keywords: Intersphincteric resection (ISR)
Transabdominal ISR
Top-down ISR
Transanal ISR
Rectal cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Completion of transabdominal ISR
timeFrame: About one week
Secondary outcomes:
measure: Circumferential resection margin (CRM)
timeFrame: About one week
measure: Distal and proximal resection margin
timeFrame: About one week
measure: Length of operation time
timeFrame: Through the completion of surgery, an average of 5 hours
measure: Length of postoperative ileus
timeFrame: 30 days
measure: Hospitalization
timeFrame: After patients' discharge from hospital, an average of 7 days
measure: Degree of postoperative pain
timeFrame: After patients' discharge from hospital, an average of 7 days
measure: Intraoperative complications
timeFrame: Within 5 hours
measure: The wound infection
timeFrame: 30 days
measure: Acute anastomotic leakage
timeFrame: 30 days
measure: Chronic anastomotic leakage
timeFrame: 6 months
measure: Questionnaire to assess disability
timeFrame: 6 months
measure: Fecal incontinence
timeFrame: 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Jin-Tung LIANG
Study officials:
affiliation: National Taiwan University Hospital
name: Jin-Tung LIANG, PhD
role: STUDY_DIRECTOR
References: