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

Primary Purpose

Uncomplicated Acute Appendicitis

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Clinical Pathway with "Fast-Track"
Postoperative Usual Protocol
Sponsored by
Hospital Universitario Virgen de la Arrixaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncomplicated Acute Appendicitis focused on measuring Acute Appendicitis, Appendectomy, Fast-Track, Clinical Pathway

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Virgen de La ArrixacaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Clinical Pathway With "Fast-Track"

Postoperative Usual Protocol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative Hospital Stay
Measure the time from when the patient leaves the operating room until discharge

Secondary Outcome Measures

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

Full Information

First Posted
December 15, 2014
Last Updated
December 26, 2014
Sponsor
Hospital Universitario Virgen de la Arrixaca
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1. Study Identification

Unique Protocol Identification Number
NCT02326415
Brief Title
Clinical Pathway With "Fast-Track" In Uncomplicated Acute Appendicitis
Acronym
CLIPUA
Official Title
Prospective Randomised Study Comparing Clinical Pathway With "Fast-Track" Versus Usual Protocol In Uncomplicated Acute Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Virgen de la Arrixaca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Acute Appendicitis
Keywords
Acute Appendicitis, Appendectomy, Fast-Track, Clinical Pathway

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical Pathway With "Fast-Track"
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Postoperative Usual Protocol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical Pathway with "Fast-Track"
Intervention Description
Care described in the critical pathway during postoperative like the moment when the patients can eat, can move or are discharged.
Intervention Type
Other
Intervention Name(s)
Postoperative Usual Protocol
Intervention Description
Cares step by step as sugery responsable thinks are the best for patients until discharge.
Primary Outcome Measure Information:
Title
Postoperative Hospital Stay
Description
Measure the time from when the patient leaves the operating room until discharge
Time Frame
From the first moment after surgery within 3 months
Secondary Outcome Measure Information:
Title
Overall satisfaction (Study the degree of satisfaction that the patient has received assistance as)
Description
Study the degree of satisfaction that the patient has received assistance as
Time Frame
From the first moment after surgery within 3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesus Abrisqueta, Ph D
Phone
+34 968369677
Email
j_abris@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Víctor Soriano, MD
Phone
+34 676297253
Email
victor_soriano_@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan A. Luján Mompean
Organizational Affiliation
Hospital Clínico Universitario Virgen de la Arrixaca
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario Virgen de La Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Abrisqueta, Ph D
Phone
+34 968369677
First Name & Middle Initial & Last Name & Degree
víctor Soriano, MD
First Name & Middle Initial & Last Name & Degree
Juan Lujan, Ph D

12. IPD Sharing Statement

Learn more about this trial

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

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