The Same-Day_FundoRing trial: protocol for a randomized controlled clinical trial of the same-day discharges after "FundoRing" gastric bypass for obesity patients in ambulatory surgery center with integrated apartments

同日FundoRing试验:一项随机对照临床试验方案,旨在研究在配备公寓的门诊手术中心,肥胖患者接受“FundoRing”胃旁路手术后当日出院的可行性。

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Abstract

BACKGROUND: Outpatient surgery means that the patient patient has surgery and often goes home on the same day. Safety and utilization outcomes were similar between outpatient and inpatient bariatric surgeries, and outpatients were associated with shorter hospital readmission lengths of stay. At the same time, it is necessary to evaluate how the possibility of accommodating an operated patient, for example, in an apartment integrated with the Ambulatory Surgical Center (ASC), will allow for discharge on the same day or one day after surgery. The researchers suggest that the differences in the "increased length of stay" criterion between the "same-day" (outpatients) and "one-day" (inpatients) groups after the procedure are minor. The safety and readmission rates of outpatients and inpatients who underwent laparoscopic gastric bypass using FundoRing were comparable. The objective of this study was to first aim to assess the cases of the extra length of stay of the pre-planned discharge date and the difference and reason between the "fit for discharge" and "actual discharge" dates. The second aim was to assess the safety and readmission of outpatient same-day and one-day laparoscopic one anastomosis gastric bypass by using the "FundoRing" method with an enhanced recovery protocol and remote monitoring in the ambulatory surgery center with integrated apartments. METHODS: The study design was a single-center prospective, interventional, open-label (no masking) RCT with 1-year follow-up. Adult obese patients (n = 200) were randomly allocated to one of two groups. Experimental surgical bariatric group: first (A) group: patients (n = 100) (Same-DayFundoRingOAGB group); active comparator surgical bariatric group; second (B) group: patients (n = 100) (One-DayFundoRingOAGB group). The Same-DayFundoRingOAGB group was assessed as outpatients and the One-DayFundoRingOAGB group as inpatients. DISCUSSION: The study participants were divided into two groups based on their discharge date. This study identified subjective and objective factors influencing discharge timing. It will answer the question: How can the difference between the "fit for discharge" and "actual discharge" dates be minimized? What interventions could have influenced this? An answer will also be given to the question: How can an apartment integrated with the ASC reduce the extra length of stay at the ASC? TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT07189416. The Same-Day trial was retrospectively registered on 09.22.2025.

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