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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Cases of "The day of discharge corresponds to the planned discharge date"or Cases without Extra length of stay (ELoS)).
研究概览
简要总结
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].
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •ASA condition 3-4
- •Obesity with a body mass index (BMI) more 50 kg / m2
- •Refusal of randomization
研究组 & 干预措施
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
干预措施: 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)
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
干预措施: 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)
结局指标
主要结局
Cases of "The day of discharge corresponds to the planned discharge date"or Cases without Extra length of stay (ELoS)).
时间窗: 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
时间窗: first week
Cases of rehospitalization (Readmission)
Cases of transfer to an urgent care clinic
时间窗: first week
Cases of transfer to an urgent care clinic after serious complication
Cases of "The day of discharge corresponds to the planned discharge date"or Cases without Extra length of stay (ELoS)).
时间窗: 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
时间窗: first week
Cases of rehospitalization (Readmission)
Cases of transfer to an urgent care clinic
时间窗: first week
Cases of transfer to an urgent care clinic after serious complication
次要结局
- Change of preop and body mass index(preop and 12 months postop].)
- Change of preop and body mass index(preop and 12 months postop].)