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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 Outcome Measure: 1. The Extra Length of Stay in Same-Day and One-Day 2. Safety (Cases of Complication).The measure is assessing a surgical complication 3. The measure is assessing a cases of readmission. \[Time Frame: first week, at 1, 6, 12 months after surgery\] Secondary Outcome Measures: The measure is assessing a cases of readmission. \[Time Frame: first week, at 1, 6, 12 months after surgery\]

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Kazakhstan
Oral Ospanov
RECRUITING
Astana
Contact Information
Primary
Oral Ospanov, Professor
bariatric.kz@gmail.com
87015287734
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2025-11-15
Participants
Target number of participants: 200
Treatments
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
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
Related Therapeutic Areas
Sponsors
Leads: The Society of Bariatric and Metabolic Surgeons of Kazakhstan

This content was sourced from clinicaltrials.gov