NCT02326415

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 29, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

December 15, 2014

Last Update Submit

December 26, 2014

Conditions

Keywords

Acute AppendicitisAppendectomyFast-TrackClinical Pathway

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 COMPARATOR

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"

Postoperative Usual Protocol

ACTIVE COMPARATOR

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

Interventions

Care described in the critical pathway during postoperative like the moment when the patients can eat, can move or are discharged.

Clinical Pathway With "Fast-Track"

Cares step by step as sugery responsable thinks are the best for patients until discharge.

Postoperative Usual Protocol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Appendicitis

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Juan A. Luján Mompean

    Hospital Universitario Virgen de la Arrixaca

    STUDY DIRECTOR

Central Study Contacts

Jesus Abrisqueta, Ph D

CONTACT

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

Locations