The aim of the study is to investigate the feasibility and safety of same-day discharge of laparoscopic Sleeve Gastrectomy in a select group of patients.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
morbide obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the number of patients who are discharged successfully
at the day of the surgery.
Secondary outcome
Complications, mortality, ER-visits, readmissions and re-operations.
Background summary
In the Netherlands, over 12.000 bariatric procedures are performed annually.
Due to an exponential growth of the population with morbid obesity in the last
decade, a further increase in eligible patients for bariatric surgery is
expected. The introduction of laparoscopic techniques in bariatric surgery and
implementation of the ERAS (Enhanced Recovery After Surgery) pathways has
considerably reduced hospital admission time. Several studies have shown that
shortening of postoperative hospital stay does not affect patient*s short-term
safety. It has been proved feasible and safe to perform Gastric Bypass in
ambulatory care for a select group of patients.
Study objective
The aim of the study is to investigate the feasibility and safety of same-day
discharge of laparoscopic Sleeve Gastrectomy in a select group of patients.
Study design
A feasibility study of 50 cases
Intervention
Included patient will be discharged at the same day of the surgery if they meet
a number of criteria (i.e. no abnormalities or complications during surgery or
anesthesia, stable vital signs, stable Hemoglobin-level, approval of surgeon
and patient). On the first postoperative day, the patient is called by the
surgeon; on postoperative day 2 or 3, the patient has a thorough medical
checkup at the outpatient clinic.
Study burden and risks
By participation in the present study patients will be discharged on the day of
the surgery if they meet a number of (safety)criteria to minimize the risk of
complications. The next day, the patient is called by the surgeon. On
postoperative day 2 or 3, there is a physical medical examination at the
outpatient clinic. Patient is being informed how and when to contact the
hospital (24/7) in case of abnormalities.
All bariatric patients have a risk of developing complications, regardless the
length of hospital stay. Late recognition of complications may lead to
increased morbidity and mortality. Chances of complications are limited if
patient feel well and have normal vital parameters at the time of discharge.
Through remote monitoring and the scheduled appointments, we still observe the
patient, but do it remotely.
This results in a decrease in burden on hospital capacity and an increase of
patient satisfaction, by letting patients recover in their own environment.
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Jan Tooropstraat 164
Amsterdam 1061 AE
NL
Listed location countries
Age
Inclusion criteria
Morbidly obese patients (IFSO criteria of morbid obesity) aged between the 18
and 65 years with a BMI < 50 kg/m2
Primary Laparoscopic Sleeve Gastrectomy
The operation will start before 12.00 PM and is the first, second or third
procedure on the bariatric program of the day
Master the Dutch language
Patient is able to understand and use the remote medical devices
Residing within a radius of 45 minutes* drive from the OLVG Hospital, location
West
An informal carer is available to be at the patient*s side during the 24 hours
following hospital discharge.
Exclusion criteria
Uncontrolled diabetes mellitus or use of insulin, cardiac disease (history of
myocardial infarction, heart rhythm disorder) and coagulation abnormalities or
use of anticoagulants.
Large abdominal surgeries in the past, including abdominal laparotomy
Disapproval for daycare by anesthesiologist or surgeon
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80532.100.22 |