Overview
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 Outcome Measure:
- The Extra Length of Stay in Same-Day and One-Day
- Safety (Cases of Complication).The measure is assessing a surgical complication
- 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]
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 .
Eligibility
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