Artificial Intelligence Assists Surgeons' Decision Making

NCT04999007 | Recruiting

• 1 other identifier: TJ-IRB20210643
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rectal Cancer

Keywords

artificial intelligence,; rectal cancer; temporary ileostomy; anastomotic leakage

Outcome Measures

Primary Outcomes (2)

• The rate of temporary ileostomy.

  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.

  30 days

Study Arms (2)

Control

NO INTERVENTION

Whether the patients in the control arm will receive a temporary ileostomy depends on surgeons' experience.

Intervention

EXPERIMENTAL

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.

Other: Artificial intelligence algorithm

Interventions

Artificial intelligence algorithm OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged older than 18 years and younger than 85 years.
• Primary rectal adenocarcinoma confirmed by preoperative pathology result.
• Expected curative resection via total mesorectal excision procedure.
• American Society of Anesthesiologists (ASA) class I, II, or III.
• Written informed consent.

You may not qualify if:

• Pregnant or breastfeeding women.
• Severe mental disorder or language communication disorder.
• Hartmann surgery or colostomy is performed intraoperatively.
• Interrupted of surgery for more than 30 minutes due to any cause.
• Malignant tumors with other organs

Sponsors & Collaborators

• Jichao Qin: lead

Study Sites (1)

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

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jichao Qin, MD

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jichao Qin, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: August 10, 2021
• Study Start: September 2, 2021
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)