To provide evidence whether a new perioperative care pathway for patients requiring an ileo- or colostomy reduces complication rates and improves quality of life against acceptable costs. Previous national surveys among ostomates and stoma care…
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome measures: Stoma-related complications within 3 months after the ostomy
has been placed.
Secondary outcome
stoma-related quality of life, number of readmissions, number and costs of
consumables used for stoma care, number of outpatient and home visits and
personnel involved within the follow-up period.
Background summary
In patients with inflammatory or malignant bowel diseases an ileostomy or
colostomy is a frequently applied intervention for example to deviate faecal
flow to the abdominal wall to allow for recovery of the more distal, diseased
or operated, parts of the bowel. In the Netherlands, over 2000 patients (UK:
9000) yearly receive an ileostomy for various inflammatory or malignant bowel
disorders. Although this stoma is meant to be temporary, it usually remains in
situ for months and may even become permanent in some patients.
From both national and international publications we know that having a stoma
seriously impacts patients' daily functioning (Bakx 2004, Redmond 2009). The
reported percentage of patients suffering from a stoma-related complication
ranges from 19 to 70% (Ratcliff 2010, Giannakopoulis 2009, Bakx 2004). Possible
complications are peristomal leakage, skin irritation, stomal dehiscence,
retraction, protrusion, or stenosis, infection, and hemorrhage (Cottam 2007,
Kaidar-Person 2005, Bell 2005, Hallböök 2002, Park 1999, Gooszen 1998). About
40% of these complications occurs already within one month after receiving the
stoma. Risk factors for the occurrence of stoma-related complications are
obesity, inflammatory bowel diseases (Duchesne2002).
The care given by stoma care nurses may avoid complications (odds ratio 0.15,
95% confidence interval 0.03 * 0.69) (Duchesne 2002).
Three-quarters of the Dutch patients with an ostomy report having a stoma is a
serious limitation on the social, sexual, and physical levels (Bekkers 2004).
About half of these patients have had a stoma-related complication. One quarter
of them complains about a lack of knowledge, skills and education by the
caregivers. The inadequate communication is amplified by the current trend
towards shortening of the hospital stay. Finally, costs are an important
aspect, not only to healthcare but also to
the patient, in terms of out-of-pocket expenses (e.g. specific clothing, extra
cleaning and bed-linen).
Thus, this project may lead to substantial benefits, but at additional costs of
home visits by stoma care nurses. This can be worthwhile as these patients
deserve careful perioperative instruction and transmural follow-up to ensure
the best possible quality of care and quality of life.
Study objective
To provide evidence whether a new perioperative care pathway for patients
requiring an ileo- or colostomy reduces complication rates and improves quality
of life against acceptable costs. Previous national surveys among ostomates and
stoma care nurses have shown variation in care. Literature shows the incidence
of stoma-related complications is high, indicating room for improvement. Our
recent pilot study indicated that additional postoperative home visits by stoma
care nurses help improve stoma care and avoid complications. Hence, a care
pathway comprising careful perioperative instruction and postoperative
follow-up may provide a better quality of care for these patients.
Study design
Fifteen-centre cluster randomised clinical study with a stepped-wedge design,
so that at the end of the study all centres will have adopted the new care
pathway.
Intervention
Current perioperative ostomy care vs. a new pre- and postoperative ostomy care
pathway
("I-aid") including home visits
Study burden and risks
The patient will be asked to fill in a couple of questionnaires, to keep a
diary.
Patients will be visited at home by the stomatherapist.
There are no extra risks involved.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- All patients who receive a planned end or loop colo- or ileostomy
- Age between 18 and 85 years
- Written informed consent
Exclusion criteria
Life expectancy of less than one year
- BMI > 35 or < 18
- Emergency surgery
- ASA-category IV
- Insufficient command of the Dutch language or cognitively unable to complete Dutch questionnaires.
- Demention
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 | NL39077.018.11 |