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NCT04999007 | RECRUITING | Rectal Cancer


Artificial Intelligence Assists Surgeons' Decision Making
Sponsor:

J i Super Q in

Information provided by (Responsible Party):

J i Super Q in

Brief Summary:

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

Condition or disease

Rectal Cancer

Intervention/treatment

Artificial intelligence algorithm

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 616 participants
Masking : TRIPLE
Primary Purpose : DIAGNOSTIC
Official Title : Artificial Intelligence-assisted Decision Making for Temporary Ileostomy: A Prospective Randomized Controlled Trail.
Actual Study Start Date : 2021-09-02
Estimated Primary Completion Date : 2025-09
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Artificial Intelligence Assists Surgeons' Decision Making

Location Details

NCT04999007


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Locations


RECRUITING

China, Hubei

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

Wuhan, Hubei, China, 430000

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