Artificial Intelligence Assists Surgeons' Decision Making
ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorJichao Qin
About this trial
This study will evaluate whether artificial intelligence technique reduces the temporary ileostomy rate in patients with rectal cancer who receive anterior resection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged older than 18 years and younger than 85 years.
Primary rectal adenocarcinoma confirmed by preoperative pathology result.
Expected curative resection via total mesorectal excision procedure.
American Society of Anesthesiologists (ASA) class I, II, or III.
Disqualifiers
Pregnant or breastfeeding women.
Severe mental disorder or language communication disorder.
Hartmann surgery or colostomy is performed intraoperatively.
Interrupted of surgery for more than 30 minutes due to any cause.
Trial design
Design model
Parallel
Treatments tested in this trial
Artificial intelligence algorithm
Other interventionTemporary ileostomy will be performed in the patients with high-risk of anastomotic leakage and not performed in the patients with low-risk of anastomotic leakage.
Treatment groups
616 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The rate of temporary ileostomy.
Time frame
Intraoperative period2
The morbidity of anastomotic leakage.
The diagnosis of anastomotic leakage is determined when the passage of fecal material from pelvic drainage tube or the water-soluble contrast agent enema and extra-rectal imaging. Alternatively, anastomotic leakage can be diagnosed when the integrity of the anastomosis is interrupted or the appearance of pelvic abscess next to the anastomosis by computerized tomography (CT) examination or secondary surgical exploration.
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jichao Qin
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov