Artificial Intelligence Assists Surgeons' Decision Making
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Artificial intelligence algorithm.
- Who it may be relevant to
- Registry conditions: Rectal Cancer. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Artificial Intelligence-assisted Decision Making for Temporary Ileostomy: A Prospective Randomized Controlled Trail.
Overview
This study will evaluate whether artificial intelligence technique reduces the temporary ileostomy rate in patients with rectal cancer who receive anterior resection.
Detailed description
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.
Interventions
- Other Artificial intelligence algorithm
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.
Primary outcome measures
- The rate of temporary ileostomy. [Time frame: Intraoperative period]
- The morbidity of anastomotic leakage. [Time frame: 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Publications
- Shao S, Li Y, Li J, Liu L, Zeng Y, Song C, Huang W, Mu L, Qin J. Machine learning model-guided selective use of temporary diverting ileostomy in rectal cancer surgery: a randomized controlled trial. Nat Commun. 2026 May 25;17(1):6802. doi: 10.1038/s41467-026-73565-4. PMID 42185305
Identifiers
NCT: NCT04999007 · TJ-IRB20210643