Status:
COMPLETED
The Same-Day and One Day Gastric Bypass by Use the "FundoRing" Method (Same-Day_FundoRing Trial)
Lead Sponsor:
The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Conditions:
Obesity
Outpatient Surgery
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Outpatient surgery means that patient have surgery and often go home the same day. Safety and utilization outcomes were similar between outpatient and inpatient bariatric surgery, and outpatient was a...
Detailed Description
A global shift is occurring as hospital procedures move to ambulatory surgical settings. Nearly two-thirds of all operations are performed in outpatient facilities. Outpatient surgery means that pati...
Eligibility Criteria
Inclusion
- Obesity with a body mass index (BMI) from 30 to 50 kg / m2;
- Type 2 diabetes mellitus with good drug control or without the need for drug correction;
- Metabolic syndrome (MS), including insulin resistance (prediabetes), dyslipidemia, hypertriglyceridemia, with compensated arterial hypertension.
- Patients with MS should correspond to ASA condition 1-2. Only mild comorbidities without significant functional limitations. Well-controlled diabetes / hypertension, not severe lung diseases.
- Absence of severe hepatomegaly and / or low score on the rating scale for conditions for surgery.
- Absence or presence of GERD grade A or B (according to the Los Angeles classification);
- Absence or presence of a hernia of the esophageal opening up to 5 cm.
- No need for other simultaneous interventions other than hiatoplasty (cruroraphy) for GERD.
Exclusion
- ASA condition 3-4
- Obesity with a body mass index (BMI) more 50 kg / m2
- Refusal of randomization
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07189416
Start Date
July 15 2024
End Date
November 15 2025
Last Update
December 18 2025
Active Locations (1)
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1
Oral Ospanov
Astana, Kazakhstan, 010000