MedDataX Logo

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

NCT ID: NCT07189416

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Outpatient Surgery Same-Day Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

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

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Society of Bariatric and Metabolic Surgeons of Kazakhstan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oral Ospanov, Professor

Role: PRINCIPAL_INVESTIGATOR

The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oral Ospanov

Astana, , Kazakhstan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Kazakhstan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Same-Day_FundoRing

Identifier Type: -

Identifier Source: org_study_id