Clinical Pathway With "Fast-Track" In Uncomplicated Acute Appendicitis

Uncomplicated Acute Appendicitis Clinical Trial

— CLIPUA  

Official title:

Prospective Randomised Study Comparing Clinical Pathway With "Fast-Track" Versus Usual Protocol In Uncomplicated Acute Appendicitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02326415
• Other study ID #: HCUVA-CPA-JAC
• Status: Recruiting
• Phase: N/A
• First received: December 15, 2014
• Last updated: December 26, 2014
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2014
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: Jesus Abrisqueta, Ph D
• Phone: +34 968369677
• Email: j_abris[@]hotmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with uncomplicated acute appendicitis urgently.

• Signing the consent of participation and commitment to attend reviews.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Disease
• Appendicitis
• Uncomplicated Acute Appendicitis

Intervention

Other:
• Clinical Pathway with "Fast-Track"
Care described in the critical pathway during postoperative like the moment when the patients can eat, can move or are discharged.
• Postoperative Usual Protocol
Cares step by step as sugery responsable thinks are the best for patients until discharge.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de La Arrixaca	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Overall satisfaction (Study the degree of satisfaction that the patient has received assistance as)	Study the degree of satisfaction that the patient has received assistance as	From the first moment after surgery within 3 months	Yes