Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04999007

Artificial Intelligence Assists Surgeons' Decision Making

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Wuhan, Hubei, 430000, China

Location status: Recruiting

Location contact

Jichao Qin, MD

CONTACT

+86-27-69378479

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. The rate of temporary ileostomy.

    Time frame: Intraoperative period

  2. The morbidity of anastomotic leakage.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jichao Qin, MD

CONTACT

[email protected]

+86-27-83665316

Sponsors and collaborators

Lead sponsor

Jichao Qin

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 10, 2021
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.