Clinical Pathway With "Fast-Track" In Uncomplicated Acute Appendicitis
CLIPUA
Prospective Randomised Study Comparing Clinical Pathway With "Fast-Track" Versus Usual Protocol In Uncomplicated Acute Appendicitis
1 other identifier
interventional
300
1 country
1
Brief Summary
The aim of this study is to reduce the postoperative hospital stay, without increasing morbidity and mortality postoperative, expressed in terms of rate of complications and readmissions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 15, 2014
CompletedFirst Posted
Study publicly available on registry
December 29, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 29, 2014
December 1, 2014
8 months
December 15, 2014
December 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Hospital Stay
Measure the time from when the patient leaves the operating room until discharge
From the first moment after surgery within 3 months
Secondary Outcomes (1)
Overall satisfaction (Study the degree of satisfaction that the patient has received assistance as)
From the first moment after surgery within 3 months
Study Arms (2)
Clinical Pathway With "Fast-Track"
ACTIVE COMPARATORAll the clinical performances that the health personal have to do about the patient with uncomplicated acute appendicitis is already established in a care maps since the patient comes to hospital until the discharge.
Postoperative Usual Protocol
ACTIVE COMPARATORThe postoperative time and the clinical cares in patients with uncomplicated acute appendicitis, are defined by responsability sugery as he thinks he should be according to the literature.
Interventions
Care described in the critical pathway during postoperative like the moment when the patients can eat, can move or are discharged.
Cares step by step as sugery responsable thinks are the best for patients until discharge.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with uncomplicated acute appendicitis urgently.
- Signing the consent of participation and commitment to attend reviews.
You may not qualify if:
- Suspected liver disease.
- Coagulation disorders.
- Patients in septic shock.
- Pregnant patients.
- Patients with symptoms compatible with acute uncomplicated appendicitis (plastron appendix, perforated appendicitis or diffuse peritonitis), or had 5 to more days of evolution).
- No sign consent for participation in it.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Virgen de La Arrixaca
Murcia, Murcia, 30120, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Juan A. Luján Mompean
Hospital Universitario Virgen de la Arrixaca
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph D
Study Record Dates
First Submitted
December 15, 2014
First Posted
December 29, 2014
Study Start
May 1, 2013
Primary Completion
January 1, 2014
Study Completion
December 1, 2016
Last Updated
December 29, 2014
Record last verified: 2014-12