CompletedNot Applicable

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

Kazakhstan200 participantsStarted 2024-07-15

Plain-language 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) \[Time Frame: preop and 12 months postop\].

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * ASA condition 3-4 * Obesity with a body mass index (BMI) more 50 kg / m2 * Refusal of randomization

What they're measuring

Cases of "The day of discharge corresponds to the planned discharge date"or Cases without Extra length of stay (ELoS)).

Timeframe: Same postoperative day (POD 0), 1 postoperative day (POD 1)

Case of readmission

Timeframe: first week

Cases of transfer to an urgent care clinic

Timeframe: first week

Trial details

NCT IDNCT07189416

SponsorThe Society of Bariatric and Metabolic Surgeons of Kazakhstan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-01