The aim of the study is to assess if hospitalization can be reduced with the use of an early discharge protocol, named *ULTRA-ERAS*, in combination with tele monitoring in patients in elective colorectal surgery
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Health condition
postoperatieve zorg
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clavien Dindo >=3 complication rates (%) and initial length of stay (days)
Secondary outcome
success rate of *ULTRA-ERAS* (defined as <24hr length of stay), Total 30d LOS
(incl. readmission), 30d complication rate, readmission rates (%), 30d
mortality (%), patient satisfaction two weeks after hospitalization measured by
5-likert scale questionnaire, employee satisfaction halfway and after last
inclusion of pilot study measured by 5-likert scale questionnaire and
semi-structured interviews
Background summary
Over the last decade, Enhanced Recovery After Surgery (ERAS) protocols are
widely integrated in abdominal surgery. This improved the procedures from a
medical, financial and logistical perspective. Procedures such as
cholecystectomy and bariatric surgery have already been shown to be
successfully performed in combination with discharge within twenty-four hours.
Current literature suggests that length of stay after colorectal surgery could
safely be further reduced, in carefully selected patients by following a clear
and structured protocol. Reduction of length of stay might help reduce hospital
costs and could increase bed capacity in future healthcare.
Study objective
The aim of the study is to assess if hospitalization can be reduced with the
use of an early discharge protocol, named *ULTRA-ERAS*, in combination with
tele monitoring in patients in elective colorectal surgery
Study design
Prospective pilot intervention study
Intervention
All included patients will be treated according to our ULTRA-ERAS protocol.
This protocol aims for discharge within twenty-four hours. After discharge they
will receive a telemonitoring app to monitor complaints and vital parameters
for the first five days at home.
Study burden and risks
Participants will undergo colorectal surgery and follow the ULTRA-ERAS
protocol, which aims at discharge <24 hours after surgery. Previous research
has shown that <24hr discharge is safe compared to usual care (1-3). Although
patients will be discharge approximately two to three days earlier than usual,
we minimize burden and risk by including many checkpoints in our protocol
during hospitalization, thereby ensuring patient safety. Patients risk after
discharge will be minimized by ensuring a 24/7 telephonic availability
in-hospital nurse consultation and digital registration of complaints and vital
parameters trough a mobile app.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
- Elective minimal invasive right/left/hemicolectomy, ileocoecal or sigmoidal
resection
- Uncomplicated procedure at sign-out
- Both benign and malignant indications for surgery
- Age <=80 years
- ASA score I or II
- Complete understanding of procedure and compliance
- A person at home during the first four days and living in a non-public living
space (such as Leger des Heils)
- Lives within a half hour travel radius to the hospital and owns
transportation to hospital
Exclusion criteria
- Anti-coagulants which require bridging
- Insulin dependent diabetes
- Multi-visceral resections
- Perioperative adhesiolysis, presence of abscess or need for enterostomy
- Perioperative conversion
- Perioperative placement of drains or gastric tubes
- cT4 tumours
- Lives in a public living space (such as Leger des Heils)
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 | NL81715.100.22 |