ObesityNCT07189416
The Same-Day and One Day Gastric Bypass by Use the "FundoRing" Method (Same-Day_FundoRing Trial)
A study testing Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated Apartments in people with Obesity and Outpatient Surgery, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Outpatient Surgery, Same-Day Surgery
- What is being tested?
- Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated Apartments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteKazakhstan
- Study dates
- 15 Jul 2024to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- ASA condition 3-4
- Obesity with a body mass index (BMI) more 50 kg / m2
- Refusal of randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- 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].
- Cases of readmission (rehospitalization) after discharge due to pain, dehydration, and other non-serios surgical complications). [Time Frame: first week].
- 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].
Read the 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 .
- Conditions
- Obesity, Outpatient Surgery, Same-Day Surgery
- Being tested
- Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated Apartments
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated ApartmentsProcedure or surgery
Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated Apartments
| Study group | Role | What they receive |
|---|---|---|
| The Same-Day Discharge | 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 with the Same-Day Discharge Receives: 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 | 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 with the One -Day Discharge Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cases of "The day of discharge corresponds to the planned discharge date"or Cases without Extra length of stay (ELoS)).
Cases of the extra length of stay in Same-Day and One-Day groups after intervention
Measured: Same postoperative day (POD 0), 1 postoperative day (POD 1)
Case of readmission
Cases of rehospitalization (Readmission)
Measured: first week
Cases of transfer to an urgent care clinic
Cases of transfer to an urgent care clinic after serious complication
Measured: first week
Secondary outcomes (1)
Change of preop and body mass index
Change of preop and body mass index (BMI) (kg/m2)
Measured: preop and 12 months postop].
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start15 Jul 2024
- Primary completion1 Nov 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Society of Bariatric and Metabolic Surgeons of Kazakhstan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oral Ospanov, Professor, Principal investigator, The Society of Bariatric and Metabolic Surgeons of Kazakhstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189416
- Sponsor's protocol ID
- Same-Day_FundoRing
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ospanov O, Sultanov K, Koikov V, Zharov N, Dildabekov Z, Shakenov A, Yelembayev B, Duysenov G, Ospanova S. 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. Trials. 2026 Feb 9;27(1):207. doi: 10.1186/s13063-026-09530-9.
PubMed 41656264
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07189416
- Acronym / sponsor ID
- Same-Day_FundoRing
- Conditions
- Obesity, Outpatient Surgery, Same-Day Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Society of Bariatric and Metabolic Surgeons of KazakhstanUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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].
- Cases of readmission (rehospitalization) after discharge due to pain, dehydration, and other non-serios surgical complications). [Time Frame: first week].
- 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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Same-Day Discharge | Experimental | Procedure: Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated ApartmentsLaparoscopic 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 |
| The One -Day Discharge | Active comparator | Procedure: Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated ApartmentsLaparoscopic 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- ASA condition 3-4
- Obesity with a body mass index (BMI) more 50 kg / m2
- Refusal of randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated ApartmentsLaparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated Apartments | Procedure or surgery | The One -Day Discharge, The Same-Day Discharge |
Primary outcome
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
Case of readmission
Time frame: first week
Cases of rehospitalization (Readmission)
Cases of transfer to an urgent care clinic
Time frame: first week
Cases of transfer to an urgent care clinic after serious complication
1 secondary outcome
Change of preop and body mass index
Time frame: preop and 12 months postop].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Results publication: PubMed 41656264Ospanov O, Sultanov K, Koikov V, Zharov N, Dildabekov Z, Shakenov A, Yelembayev B, Duysenov G, Ospanova S. 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. Trials. 2026 Feb 9;27(1):207. doi: 10.1186/s13063-026-09530-9.
- BMC journals have moved to Springer Nature LinkLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oral Ospanov, Professor principal investigator
The Society of Bariatric and Metabolic Surgeons of Kazakhstan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic One Anastomosis Gastric Bypass by Use the "FundoRing" method with Enhanced Recovery Protocol and Remote Monitoring in Ambulatory Surgery Center with Integrated Apartments in people with Obesity and Outpatient Surgery, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07189416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.