Clinical trial · Interventional
Artificial Intelligence Assists Surgeons' Decision Making
Artificial Intelligence-assisted Decision Making for Temporary Ileostomy: A Prospective Randomized Controlled Trail.
NCT04999007CI-TRIAL-00082842recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate whether artificial intelligence technique reduces the temporary ileostomy rate in patients with rectal cancer who receive anterior resection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artificial intelligence algorithm | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Whether the patients in the control arm will receive a temporary ileostomy depends on surgeons' experience.
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 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.
- interventionNames
- Other: Artificial intelligence algorithm
Primary outcomes (2)
- measure
- The rate of temporary ileostomy.
- timeFrame
- Intraoperative period
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDShao 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