Using artificial intelligence to help surgeons decide on ileostomy for rectal cancer patients
Artificial Intelligence-assisted Decision Making for Temporary Ileostomy: A Prospective Randomized Controlled Trail.
This study is testing whether an artificial intelligence tool can help surgeons decide if rectal cancer patients really need a temporary ileostomy after surgery, to reduce complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 616 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT04999007 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an artificial intelligence model in reducing the rate of temporary ileostomy in patients undergoing anterior resection for rectal cancer. The model, developed from data on 2,369 rectal cancer patients, aims to assist surgeons in making informed decisions regarding the necessity of a temporary ileostomy, which is often based on individual experience rather than standardized guidelines. By utilizing this AI-driven approach, the study seeks to minimize the risk of anastomotic leakage, a serious complication associated with the surgery. Participants will be randomly assigned to either the AI-assisted decision-making group or the standard care group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with primary rectal adenocarcinoma who are expected to undergo curative resection.
Not a fit: Patients with severe mental disorders, those undergoing Hartmann surgery, or those with other malignant tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the incidence of temporary ileostomy and its associated complications in rectal cancer patients.
How similar studies have performed: While the application of AI in surgical decision-making is a growing field, this specific approach to reducing ileostomy rates in rectal cancer surgery is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged older than 18 years and younger than 85 years. 2. Primary rectal adenocarcinoma confirmed by preoperative pathology result. 3. Expected curative resection via total mesorectal excision procedure. 4. American Society of Anesthesiologists (ASA) class I, II, or III. 5. Written informed consent. Exclusion Criteria: 1. Pregnant or breastfeeding women. 2. Severe mental disorder or language communication disorder. 3. Hartmann surgery or colostomy is performed intraoperatively. 4. Interrupted of surgery for more than 30 minutes due to any cause. 5. Malignant tumors with other organs
Where this trial is running
Wuhan, Hubei
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Jichao Qin, MD — Huazhong University of Science and Technology
- Study coordinator: Jichao Qin, MD
- Email: jcqin@tjh.tjmu.edu.cn
- Phone: +86-27-83665316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.