Artificial Intelligence Assists Surgeons' Decision Making

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04999007
• Other study ID #: TJ-IRB20210643
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2021
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: Jichao Qin, MD
• Phone: +86-27-83665316
• Email: jcqin[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 616
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Jichao Qin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of temporary ileostomy.		Intraoperative period
Primary	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