Measuring small bowel length in obese patients using imaging techniques
Set up and Validation of Total Small Bowel Length Measurement Using Computed Tomography and Magnetic Resonance Imaging With 3D Reconstruction and Artificial Intelligence Tool in Obese Patients Candidates to Metabolic Surgery
This study is testing a new way to measure the length of the small intestine in obese patients using imaging techniques before their weight loss surgery to see if it can make the surgery safer and more effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 195 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT06065917 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate an automated method for measuring the total small bowel length (TSBL) in obese patients preparing for laparoscopic bariatric surgery. By utilizing preoperative imaging techniques such as computed tomography (CT) and magnetic resonance imaging (MRI), the study seeks to provide a reliable and non-invasive alternative to the traditional intraoperative measurement. The implementation of an artificial intelligence algorithm will enhance the accuracy and reproducibility of the measurements, potentially reducing surgical complications and improving patient outcomes. The study will assess the variability of TSBL to inform surgical strategies and optimize patient care.
Who should consider this trial
Good fit: Ideal candidates for this study are obese patients with a BMI greater than 35 kg/m2 and at least one obesity-related comorbidity, or those with a BMI greater than 40 kg/m2.
Not a fit: Patients who do not meet the BMI criteria or those who have not failed prior dietary or medical treatments for obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer bariatric surgeries and better long-term outcomes for patients with obesity.
How similar studies have performed: While some studies have shown promising results using CT and MRI for measuring TSBL, this study's approach utilizing AI for automated measurement is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI \> 35 kg/m2 and at least one obesity-related comorbidity * BMI \> 40 kg/m2 * failure of at least six months of dietary and/or medical treatment of obesity * indication for intervention validated after multidisciplinary evaluation in a specific board meeting
Where this trial is running
Rome, RM
- Azienda Ospedaliera Universitaria Sant'Andrea — Rome, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Niccolò Petrucciani, MD
- Email: niccolo.petrucciani@uniroma1.it
- Phone: 3496311476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.