Artificial Intelligence Assists Surgeons' Decision Making

Jichao Qin616 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

616

Conditions

Rectal Cancer

Interventions

Artificial intelligence algorithmOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

The rate of temporary ileostomy.

Time frame: Intraoperative period

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.

Time frame: 30 days

Central Contacts

Jichao Qin, MD

CONTACT

+86-27-83665316 jcqin@tjh.tjmu.edu.cn

Data from ClinicalTrials.gov

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