Readmission and Dehydration Prevention in Patients With Elective Ileostomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMultidisciplinary Italian Study group for STOmas (MISSTO)
About this trial
The goal of this prospective observational study is to evaluate the adherence to DRIP score calculation and the application rate of each proposed item to prevent dehydration and readmission in patients undergoing ileostomy creation after elective colorectal resection different Italian colorectal surgical centers.
The primary endpoint is to verifythe application rate of DRIP score calculation and protocol items.
Secondary endpoints are 30, 90, and 180-day total and dehydration readmission rates.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients with elective ileostomy performed during the study period for benign or malignant colorectal disease
Age > 18 years
Written consent
Disqualifiers
Emergency surgery
Other ostomy than ileostomy
Trial population
Consecutive patients undergoing ileostomy creation after elective colorectal resection in different Italian colorectal surgical centers.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: Ileostomy patients
Trial outcomes
Primary outcomes
1
DRIP score calculation and protocol items
Application rate of DRIP score calculation and protocol items
Time frame
From enrollment to the end of recruitment at 6 monthsSecondary outcomes
1
Readmission rates
30, 90, and 180-day total and dehydration readmission rates
Time frame
From enrollment to the end of recruitment at 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Multidisciplinary Italian Study group for STOmas (MISSTO)
Lead sponsor
Convatec Limited
Collaborator
Source ClinicalTrials.gov