Comparing 2D 4K and 3D HD imaging in bariatric surgery
Comparison of 2D 4K vs. 3D HD Laparoscopic Imaging Systems in Bariatric Surgery: a Randomized Controlled Prospective Trial
This study is testing whether using 2D 4K or 3D HD imaging during gastric bypass surgery helps patients recover faster and improves the surgery's success.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clarunis - Universitäres Bauchzentrum Basel Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT05895058 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two different imaging systems, 2D 4K and 3D HD, during gastric bypass surgery. Laparoscopy is a crucial technique in modern surgery, and the choice of imaging system can significantly impact surgical outcomes such as operation time, precision, and recovery. The study will evaluate how these two systems perform in a clinical setting, focusing on metrics like operation duration and patient recovery. By addressing the lack of comparative studies in this area, the trial seeks to provide valuable insights into the optimal imaging technology for bariatric procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with a BMI greater than 35 who have not achieved weight loss through conservative dieting for two years.
Not a fit: Patients with a BMI over 50, serious underlying health conditions, or those who do not meet the criteria for gastric bypass will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and faster recovery times for patients undergoing gastric bypass surgery.
How similar studies have performed: While there have been studies showing benefits of 3D systems over 2D, the comparison between 2D 4K and 3D HD systems is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with the indication for gastric bypass according to SMOB guidelines: BMI \> 35, Age \> 18 and Cumulative two years of controlled conservative dieting without weight loss * Informed Consent signed by the patient Exclusion Criteria: * Patients who do not have an indication for gastric bypass due to one or more of the criteria listed here: BMI \> 50, Lack of adequate weight loss therapy for two years, Malignant disease, Liver cirrhosis Child A, Morbus Crohn, Carcinoma patients, Serious mental illness requiring treatment (not attributable to obesity), Chronic abuse of drugs, Lack of compliance (missed appointments, inability to cooperate), Lack of understanding of the requirements and conditions of postoperative therapy and treatment (confirmed by the specialist) * Patient does not sign Informed Consent
Where this trial is running
Basel
- Clarunis University Center for Gastrointestinal and Liver Diseases — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Marko Kraljevic, PD Dr. med. — Clarunis - Universitäres Bauchzentrum Basel
- Study coordinator: Tibor Andrea Zwimpfer, Dr. med.
- Email: tibor.zwimpfer@unibas.ch
- Phone: 079 901 79 66
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.