Clinical Trial

The Same-Day and One Day Gastric Bypass by Use the "FundoRing" Method (Same-Day_FundoRing Trial)

Completed
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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 associated with shorter hospital readmission length of stay. This outpatient type of surgery called as ambulatory surgery center (ASC), same-day surgery (SDD), or office-based surgery (OBS). Researcher hypothesize that the safety (complication) and readmision after same-day and one day discharge of outpatient use laparoscopic one anastomosis gastric bypass by the FundoRing method are similar. The objective of this study was to assess the safety and readmision of outpatient same-day and one - night (standard) laparoscopic one anastomosis gastric bypass by use the "FundoRing" method with enhanced recovery (ERAS) protocol and remote monitoring in ambulatory surgery center (ASC) with integrated apartments. Methods: Adult participants (n=200) are randomly allocated to one of two groups: Experimental surgical bariatric group - the first (A) group: patients (n=100) (Same-Day\_FundoRingOAGB group); Active comparator surgical bariatric group - the second (B) group: patients (n=100) (Standard\_FundoRingOAGB group). Primary Outcomes 1. Cases of "The day of discharge corresponds to the planned discharge date" or Cases without Extra length of stay (ELoS)). Extra length of stay = differences between day "the day of discharge corresponds to the planned discharge date" and day "the discharge date does not match the planned date". \[Time Frame: same day discharge for first group (POD0) and one day discharge (POD1) for one day group\]. 2. Cases of readmission (rehospitalization) after discharge due to pain, dehydration, and other non-serios surgical complications). \[Time Frame: first week\]. 3. Cases of transfer to an urgent care clinic \[Time Frame: first week\]. Secondary outcomes Change of preop and body mass index (BMI) (kg/m2) \[Time Frame: preop and 12 months postop\].
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-09-16; most recent amendment 2026-03-16.
Status change: Recruiting → Completed 2025-12-10
Status change: Completed → Recruiting 2025-09-29
Trial Details
NCT Number NCT07189416
Lead Sponsor The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Conditions Obesity, Outpatient Surgery, Same-Day Surgery
Enrollment 200 participants
Start Date 2024-07-15
Primary Completion 2025-11-01 (estimated)
Study Completion 2025-11-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-18