Artificial Intelligence Assists Surgeons' Decision Making

Study Overview
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Brief Summary
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This study will evaluate whether artificial intelligence technique reduces the temporary ileostomy rate in patients with rectal cancer who receive anterior resection.

Detailed Description
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Anastomotic leakage is a serious and life-threatening complication after anterior resection in patients with rectal cancer, and temporary ileostomy was introduced to reduce the serious consequences due to anastomotic leakage. However, whether a temporary ileostomy is applied in the surgery depends on the surgeon's experience, and there are no clinical guidelines to follow. Recently, artificial intelligence has widely been applied in medical field and produced some exciting results, and we have developed a high-performance artificial intelligence model based on 2369 rectal cancer patients, which showed good discrimination of anastomotic leakage and may reduce the temporary ileostomy rate. Hence, this randomized controlled trail will evaluate the artificial intelligence model for guiding surgical decision-making of performing a temporary ileostomy in patients with rectal cancer who receive anterior resection.

Official Title
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Artificial Intelligence-assisted Decision Making for Temporary Ileostomy: A Prospective Randomized Controlled Trail.

Conditions
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Rectal Cancer

Intervention / Treatment
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* Other: Artificial intelligence algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Written informed consent. Exclusion Criteria: 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. Malignant tumors with other organs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Whether the patients in the control arm will receive a temporary ileostomy depends on surgeons' experience. | |
| Experimental: Intervention<br>Whether the patients in the intervention arm will receive a temporary ileostomy depends on the risk of anastomotic leakage calculated by the artificial intelligence algorithm. | Other: Artificial intelligence algorithm<br>* Temporary 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of temporary ileostomy. |  | Intraoperative period | 
| 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. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial intelligence,, rectal cancer, temporary ileostomy, anastomotic leakage