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

March 16, 2026 updated by: The Society of Bariatric and Metabolic Surgeons of Kazakhstan

The Same-Day and One -Day Laparoscopic Gastric Bypass by Use the "FundoRing" Method With Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center With Integreted Apartments: Randomased Clinical Trial

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].

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A global shift is occurring as hospital procedures move to ambulatory surgical settings.

Nearly two-thirds of all operations are performed in outpatient facilities. 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 (AS), same-day surgery (SDD), or office-based surgery (OBS).

If the patient needs to stay in the facility overnight after surgery, some authors still consider it outpatient surgery, while others consider it as standard care with at least one-night hospitalization. Fast track bariatric (Enhanced Recovery -ERAS) surgery provaded significantly fewer co-morbidities and lower rate of complications and readmission when discharge is Early (ED) on postoperative (POD) 1 in comparison then late discharge (LD) when discharged on POD 2 or 3. Implementing enhanced recovery after surgery (ERAS) protocols has added further benefits for laparoscopic ambulatory surgery.

Unlike office-based surgery (OBS), where operations are mainly performed under local anesthesia, ambulatory surgical centers (ASCs) require specialized equipment or deeper anesthesia techniques for more complex outpatient metabolic and bariatric surgery.

Ambulatory/outpatient metabolic and bariatric surgery provides significant economic benefits by reducing overall health care costs through more effective treatment of obesity-related conditions such as 2 types diabetes, hypertension, and high cholesterol, resulting in reduced medication use and length of stay (LoS) in the surgical center. And can reduce the risk of infection and hospital-acquired complications, offer greater comfort during recovery.

Patients undergoing laparoscopic bariatric procedures can be safely discharged on the day of their procedure without increased incidence of mortality, reoperation, or readmission.

Researcher hypothesize that the safety (complication) and readmision after same-day and one-day (night) discharge 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 - day 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 .

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • Oral Ospanov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Same-Day Discharge
Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated Apartments with the Same-Day Discharge
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
Active Comparator: The One -Day Discharge
Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated Apartments with the One -Day Discharge
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cases of "The day of discharge corresponds to the planned discharge date"or Cases without Extra length of stay (ELoS)).
Time Frame: Same postoperative day (POD 0), 1 postoperative day (POD 1)
Cases of the extra length of stay in Same-Day and One-Day groups after intervention
Same postoperative day (POD 0), 1 postoperative day (POD 1)
Case of readmission
Time Frame: first week
Cases of rehospitalization (Readmission)
first week
Cases of transfer to an urgent care clinic
Time Frame: first week
Cases of transfer to an urgent care clinic after serious complication
first week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of preop and body mass index
Time Frame: preop and 12 months postop].
Change of preop and body mass index (BMI) (kg/m2)
preop and 12 months postop].

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Investigators

  • Principal Investigator: Oral Ospanov, Professor, The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

November 15, 2025

Study Registration Dates

First Submitted

September 16, 2025

First Submitted That Met QC Criteria

September 16, 2025

First Posted (Actual)

September 24, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Same-Day_FundoRing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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