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

NCT07189416 | Completed

• 1 other identifier: Same-Day_FundoRing
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Cases of readmission (rehospitalization) after discharge due to pain, dehydration, and other non-serios surgical complications). \[Time Frame: first week\].
3. 3.Cases of transfer to an urgent care clinic \[Time Frame: first week\].

Conditions

Obesity; Outpatient Surgery; Same-Day Surgery

Outcome Measures

Primary Outcomes (3)

• 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

  Same postoperative day (POD 0), 1 postoperative day (POD 1)

• Case of readmission

  Cases of rehospitalization (Readmission)

  first week

• Cases of transfer to an urgent care clinic

  Cases of transfer to an urgent care clinic after serious complication

  first week

Secondary Outcomes (1)

• Change of preop and body mass index

  preop and 12 months postop].

Study Arms (2)

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

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

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

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• ASA condition 3-4
• Obesity with a body mass index (BMI) more 50 kg / m2
• Refusal of randomization

Sponsors & Collaborators

• The Society of Bariatric and Metabolic Surgeons of Kazakhstan: lead

Study Sites (1)

Oral Ospanov

Astana, 010000, Kazakhstan

Location

Related Publications (1)

• 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. doi: 10.1186/s13063-026-09530-9. Online ahead of print.

  PMID: 41656264 RESULT

Related Links

• BMC journals have moved to Springer Nature Link

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oral Ospanov, Professor

  The Society of Bariatric and Metabolic Surgeons of Kazakhstan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: July 15, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 15, 2025
• Last Updated: March 18, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)