Clinical Pathway With "Fast-Track" In Uncomplicated Acute Appendicitis (CLIPUA)

December 26, 2014 updated by: Jesus Abrisqueta Carrion, Hospital Universitario Virgen de la Arrixaca

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30120
        • Recruiting
        • Hospital Universitario Virgen de La Arrixaca
        • Contact:
          • Jesus Abrisqueta, Ph D
          • Phone Number: +34 968369677
        • Sub-Investigator:
          • víctor Soriano, MD
        • Sub-Investigator:
          • Juan Lujan, Ph D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clinical Pathway With "Fast-Track"
All 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.
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.
Active Comparator: Postoperative Usual Protocol
The 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.
Other: Postoperative Usual Protocol
Cares step by step as sugery responsable thinks are the best for patients until discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Hospital Stay
Time Frame: From the first moment after surgery within 3 months
Measure the time from when the patient leaves the operating room until discharge
From the first moment after surgery within 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall satisfaction (Study the degree of satisfaction that the patient has received assistance as)
Time Frame: From the first moment after surgery within 3 months
Study the degree of satisfaction that the patient has received assistance as
From the first moment after surgery within 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen de la Arrixaca

Investigators

  • Study Director: Juan A. Luján Mompean, Hospital Clínico Universitario Virgen de la Arrixaca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 15, 2014

First Submitted That Met QC Criteria

December 26, 2014

First Posted (Estimate)

December 29, 2014

Study Record Updates

Last Update Posted (Estimate)

December 29, 2014

Last Update Submitted That Met QC Criteria

December 26, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCUVA-CPA-JAC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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