Uncomplicated Acute AppendicitisCLIPUANCT02326415
Clinical Pathway With "Fast-Track" In Uncomplicated Acute Appendicitis
A study testing Clinical Pathway with "Fast-Track" and Postoperative Usual Protocol in people with Uncomplicated Acute Appendicitis, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uncomplicated Acute Appendicitis
- What is being tested?
- Clinical Pathway with "Fast-Track" and Postoperative Usual Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- May 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with uncomplicated acute appendicitis urgently.
- Signing the consent of participation and commitment to attend reviews.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen de La Arrixaca
Murcia, Murcia, 30120
Jesus Abrisqueta, Ph D, +34 968369677
víctor Soriano, MD
About this study
Official title: 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.
- Conditions
- Uncomplicated Acute Appendicitis
- Being tested
- Clinical Pathway with "Fast-Track", Postoperative Usual Protocol
- Keywords
- Acute Appendicitis, Appendectomy, Fast-Track, Clinical Pathway
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pathway with "Fast-Track"Other
Care described in the critical pathway during postoperative like the moment when the patients can eat, can move or are discharged.
Postoperative Usual ProtocolOther
Cares step by step as sugery responsable thinks are the best for patients until discharge.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Postoperative Usual Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Hospital Stay
Measure the time from when the patient leaves the operating room until discharge
Measured: 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)
Study the degree of satisfaction that the patient has received assistance as
Measured: From the first moment after surgery within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startMay 2013
- Primary completionJan 2014
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesus Abrisqueta Carrion, Hospital Universitario Virgen de la Arrixaca
- Investigators
- Juan A. Luján Mompean, Study director, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326415
- Sponsor's protocol ID
- HCUVA-CPA-JAC
- Acronym
- CLIPUA
- Status last verified
- Dec 2014
- First submitted
- 15 Dec 2014
- Last updated
- 29 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Study Comparing Clinical Pathway With "Fast-Track" Versus Usual Protocol In Uncomplicated Acute Appendicitis
- ClinicalTrials.gov ID
- NCT02326415
- Acronym / sponsor ID
- CLIPUA / HCUVA-CPA-JAC
- Conditions
- Uncomplicated Acute Appendicitis
- Keywords
- Acute Appendicitis, Appendectomy, Fast-Track, Clinical Pathway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Pathway With "Fast-Track" | Active comparator | Other: 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. |
| Postoperative Usual Protocol | Active comparator | Other: Postoperative Usual ProtocolThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with uncomplicated acute appendicitis urgently.
- Signing the consent of participation and commitment to attend reviews.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Clinical Pathway With "Fast-Track" |
| Postoperative Usual ProtocolCares step by step as sugery responsable thinks are the best for patients until discharge. | Other | Postoperative Usual Protocol |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2014.
Related trials for Uncomplicated Acute Appendicitis
Not yet recruitingPhase 2
Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
Acute Appendicitis
Recruiting
Direct Visualization ERAT Versus Laparoscopic Appendectomy in Adults With Acute Uncomplicated Appendicitis
Acute Uncomplicated Appendicitis
Not yet recruitingPhase 3
Efficacy of Non Operative Treatment With Amoxicillin/Clavulanic Acid Versus Surgical Treatment in Acute Uncomplicated Appendicitis in Children
Acute Uncomplicated Appendicitis
Recruiting
Early vs Conventional Enteral Nutrition After Uncomplicated Paediatric Open Appendectomy
Uncomplicated Acute Appendicitis in Children
Not yet recruiting
Oral Antibiotic Outpatient Therapy vs. Placebo in the Treatment of Uncomplicated Acute Appendicitis
Uncomplicated Acute Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan A. Luján Mompean study director
Hospital Universitario Virgen de la Arrixaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pathway with "Fast-Track" and Postoperative Usual Protocol in people with Uncomplicated Acute Appendicitis, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesus Abrisqueta, Ph D (+34 968369677, j_abris@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Hospital Stay (time frame: From the first moment after surgery within 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2014.