*Evaluate whether patients who are discharged early and are continuously monitored recover just as safely at home as they do in the hospital.**Evaluate whether complications can be detected in a timely manner by using continuous vital signs and…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
*Successful application of early discharge and home recovery in patients after
colorectal surgery*
Secondary outcome
*Number of patients with postoperative complications within 30 days of surgery*
*Number of contact moments with patient as a result of measurements and/or
questionnaires"
*Number of patients who die within 30 days of surgery*
*Patient satisfaction regarding the experiences of home recovery 5 days after
surgery*
Background summary
Colon cancer is one of the most common types of cancer in the Netherlands and
is expected to continue to rise. The increased demand for healthcare translates
into a high workload, longer waiting times and a lack of capacity in the
hospitals. One way to still deliver the growing need for care is through
affordable innovations that allow optimal use of hospital capacity.
The aim of the Jeroen Bosch Hospital is to provide care that best suits the
patients, within the aforementioned boundaries . This research is a new
initiative with which the Jeroen Bosch Hospital (JBZ) aims to further reduce
length of stay after colorectal surgery. This aim is in line with society's
desire to provide *the right care in the right place at the right time*. It is
also desirable that a patient continues to recover as far as possible in their
own environment, since there is increasing evidence that patients recover more
pleasantly and more quickly in a trusted environment.
Allowing patients who cope well with the operation and monitoring them from
home will (possibly) reduce the length of stay in the future, while patients
receive equally good quality treatment. When this study produces positive
results, namely evidence that early discharge in combination with home recovery
is safe, it will be introduced into clinical practice as soon as possible.
Study objective
*Evaluate whether patients who are discharged early and are continuously
monitored recover just as safely at home as they do in the hospital.*
*Evaluate whether complications can be detected in a timely manner by using
continuous vital signs and digital questionnaires*
*Evaluate whether patients recovering at home are satisfied with the treatment
offered*
Study design
single center, interventional, prospective study
Intervention
participants are dismissed earlier and recover at home where they are
continuously monitored using data from smart wearable sensors and digital
questionnaires.
Study burden and risks
Failure to timely detect complications after bowel surgery in the home
environment.
Allergic reactions to wearing the sensors
Possible stress as a result of home recovery and self-management
General discomfort while wearing the sensors (similar to wearing a watch)
Henri Dunantstraat 1 1
's-Hertogenbosch 5223 GZ
NL
Henri Dunantstraat 1 1
's-Hertogenbosch 5223 GZ
NL
Listed location countries
Age
Inclusion criteria
• Signed consent form;
• Is >= 18 years <= 80;
• BMI <= 35 kg/m2;
• WHO performance status 0 - 1
• Has been diagnosed with uncomplicated colorectal malignant tumor (eg, colon
carcinoma) or benign abnormality (eg, chronic diverticulitis)
• Is planned to undergo elective laparoscopic or robotic assisted colorectal
surgery (ileocecal resection, (extended) right or left hemicolectomy,
transverse colon resection, sigmoid and recto-sigmoid resection) with primary
anastomosis;
• Uncomplicated course of the perioperative and immediate postoperative period;
• Available ambulatory care provided by an informal caregiver or adult family
member during the recovery process;
• The patient has direct access to transport 24 hours a day;
• Patient stays within 35 km of the hospital;
• The patient (or family member) has a smartphone with mobile data and digital
skills;
• The patient (or family member) is easily reachable by telephone.
• Concerned caregiver or adult family member must be competent to perform
prescribed actions.
Exclusion criteria
• WHO-performance status >1
• Patients with a history of active lung infection, any other active infection,
an uncontrolled medical condition
• Patients with a contraindication to oral NSAIDs;
• Patients requiring parenteral nutrition prior to surgery;
• Patients scheduled to undergo lower rectal resections;
• Patients who receive a stoma;
• Patients experiencing preoperative complications;
• Patients who are mentally incompetent, challenged or need help with daily
activities.
• Patients experiencing complications per surgery
• If the operator or primary care provider decides that the patient cannot
safely be discharged early. This can also be decided after the patient has been
included in the study.
Design
Recruitment
Medical products/devices used
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 | NL79338.028.21 |