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Digital 3D Reconstruction Predicts Small Bowel Length (DTDRPSBL-BS)

A

Army Medical University of People's Liberation Army

Status

Enrolling

Conditions

Small Intestine Length Measurement

Treatments

Diagnostic Test: Small intestine length measurement method

Study type

Observational

Funder types

Other

Identifiers

NCT05338567
3DRABL-BS

Details and patient eligibility

About

The prevalence of type 2 diabetes mellitus (T2DM) has been increasing annually worldwide, and the prevalence of diabetes has reached 11.6% in China. Laparoscopic Roux-en-Y gastric bypass (RYGB) is still widely accepted as a valid surgery in the treatment of obesity and T2DM. But still, there is no consensus on the ideal of the gastric bypass limb lengths. Reported lengths of biliopancreatic limb (BPL) and alimentary limb (AL) varied widely from 10-250 to 35-250 cm, and anatomical data show that the length of small intestine varies greatly among adults. Choosing the same small bowel bypass length for different individuals obviously cannot achieve the expected weight loss effect, and individuals with too short small intestine can cause severe malnutrition complications and even life-threatening conditions. Therefore, measurement of small bowel length is one of the prerequisites for performing precise RYGB. Intraoperative measurement of small bowel length can increase the operative time and the risk of surgical complications such as intestinal perforation. So, predicting the total length of the small intestine is very important for accurately performing bariatric surgery and avoiding the risk of surgical complications. In this study, we propose to perform 3D segmentation and reconstruction of the small intestine by acquiring abdominal CT data through digital technology, and predict the small intestine length by 3D digital measurement of the small intestine, and verify the digital measurement data by performing digital measurement data. Establish a small bowel length prediction model for bariatric surgery to develop a more accurate and personalized gastric bypass surgery plan for patients to obtain weight loss and glucose control.

Enrollment

100 estimated patients

Sex

All

Ages

16 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients eligible for surgical treatment of T2DM were selected based on the Chinese Guidelines for the Surgical Treatment of Obesity and Type 2 Diabetes (2019 )

Exclusion criteria

  • Adhesions, peritonitis, and patients who have had bowel resection (small intestine, colon or rectum) that hinder the measurement of the entire intestinal length
  • Non-weight loss surgery patients whose incision is less than 6 cm are not suitable for measuring the length of the small intestine.

Trial design

100 participants in 2 patient groups

Open/laparoscopic surgery
Description:
Small bowel length measurement by laparoscopy or laparotomy
3D reconstruction
Description:
Small bowel length measurement by 3D digital model
Treatment:
Diagnostic Test: Small intestine length measurement method

Trial contacts and locations

1

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Central trial contact

fan Li, PhD

Data sourced from clinicaltrials.gov

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