Artificial Intelligence Assists Surgeons' Decision Making

Not Applicable

Recruiting

• Conditions: Rectal Cancer
• Interventions: Other: Artificial intelligence algorithm

• Registration Number: NCT04999007
• Lead Sponsor: Jichao Qin

Brief Summary

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.

Study Timeline

• Study First Submitted: 2021-08-08
• Study First Submitted QC: 2021-08-08
• Study First Posted: 2021-08-10
• Study Start: 2021-09-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 616

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Artificial intelligence algorithm	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.

Primary Outcome Measures

Name	Time	Method
The rate of temporary ileostomy.	Intraoperative period
The morbidity of anastomotic leakage.	30 days	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.

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China