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

NCT07189416 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-18

No results posted yet for this study

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

Conditions

  • Obesity
  • Outpatient Surgery
  • Same-Day Surgery

Interventions

PROCEDURE

Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated Apartments

Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated Apartments

Sponsors & Collaborators

  • The Society of Bariatric and Metabolic Surgeons of Kazakhstan

    lead OTHER

Principal Investigators

  • Oral Ospanov, Professor · The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2025-11-01
Completion
2025-11-15

Countries

  • Kazakhstan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07189416 on ClinicalTrials.gov