Rectal Cancer
Conditions
Keywords
artificial intelligence,, rectal cancer, temporary ileostomy, anastomotic leakage
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.
Interventions
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.
Sponsors
Jichao Qin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactJichao Qin, MD
Outcome results
None listed