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 range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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