NCT06598267Active, not recruiting
Evaluate the Efficacy and Safety of SASI Compared with RYGB in the Treatment of Obesity and Related Metabolic Diseases
A Prospective,Single-center,Randomized,Controlled Study to Evaluate the Efficacy and Safety of SASI Compared with RYGB in the Treatment of Obesity and Related Metabolic Diseases
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
Single anastomosis sleeve ileal bypass (SASI) is an improved surgical technique for sleeve gastrectomy (SG), which combines the advantages of SG and Roux-en-Y gastric bypass (RYGB) while avoiding their disadvantages,in order to achieve better treatment outcomes.On the one hand,SASI surgery improves the effectiveness of weight loss surgery by adding gastrointestinal anastomosis on the basis of SG,while reducing gastric pressure and improving postoperative gastroesophageal reflux symptoms.On the other hand,it also avoids the regret of RYGB surgery leaving the stomach open for gastroscopy examination and reduces the risk of postoperative nutrition related complications.Therefore,SASI surgery has demonstrated good application prospects and is expected to be promoted in clinical practice.So far,there has been no comparative study of RCTs between RYGB and SASI internationally.In order to compare the weight loss effects of SASI and RYGB surgery,this study intends to conduct a randomized controlled trial on patients who meet the criteria and require weight loss surgery,providing high-level evidence-based medicine for the further clinical development of SASI surgery in the future.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 304 (estimated)
- First submitted
- 11 Sept 2024
- Start date
- 3 Sept 2024
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Obesity
- NCT number
- NCT06598267
What you commit to
- Study type: Interventional
- Planned participants: 304
- From 3 Sept 2024 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient has undergone weight loss surgery in the past to undergo corrective surgery
Other illness
- The patient has type 1 diabetes
- The patient has a history of chronic inflammatory bowel disease
- Having psychological disorders that require monitoring
Other
- Gastroscopy indicates active gastroduodenal ulcers within the past 2 months without treatment
- The patient is pregnant or has a recent pregnancy plan
Who the study is looking for
- Patients undergoing weight loss surgery,aged 18-65 years old
- Simple obesity with a BMI exceeding 35 or a BMI exceeding 32 combined with at least 2 metabolic syndromes
- Preoperative gastroscopy examination showed no high-risk factors for gastric cancer
- Preoperative multidisciplinary evaluation is suitable for gastric bypass or dual channel surgery
- Patients understand and accept long-term follow-up
- The patient agrees to participate in the clinical study and signs an informed consent form
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.