Evaluating the Safety and Efficacy of a Outpatient Appendectomy (PENDI_CSI)

January 12, 2021 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

A Randomized Double-blind Clinical Trial to Evaluate the Safety and Efficacy of a Outpatient Appendectomy (PENDI_CSI)

This study evaluates the Safety and Efficacy of a outpatient appendectomy. Half of participants will be perform the hospitalization, while the other half will undergo the outpatient appendectomy

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Acute appendicitis (AA) is one of the most common causes of acute abdomen and one of the most frequent diagnoses that require urgent surgery worldwide.

Many laparoscopic procedures are currently performed on an outpatient basis.Laparoscopic appendectomy, however, continues to require postoperative hospitalization averaging between 1 and 2 days, at most institutions.

At present ambulatory laparoscopic appendectomy (LA) are gained popularity due to the improved understanding of patient selection criteria, the application of enhanced recovery pathways, and the potential for improving healthcare resource utilization.

There are few studies about to compare the morbidity and readmission rates between ambulatory and conventional LA.

There is a lack of high-quality comparative studies making conclusive recommendations not possible at this time. Based on current data, ambulatory LA may be safe and feasible as compared with conventional LA.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
291

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over 14 years of age and who provide informed consent to participate in the study.
  • Patients with non complicated acute appendicitis requiring and urgent appendectomy (laparoscopic or minimum incision)
  • Negative appendicectomy.

Exclusion Criteria:

  • Complicated acute appendicitis (abscess, perforated, necrosis and peritonitis)
  • Need to place intraoperative drainage.
  • Patients with American Society of Anesthesiologists (ASA) >IV.
  • Immunosuppressed patients.
  • Pregnant.
  • Possibility of inflammatory bowel disease.
  • No family support.
  • No informed consent signature.
  • Impossibility to comply with the established follow-up

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Outpatient appendectomy

Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed.

Patients after surgery will go to the anesthetic recovery room without requiring hospital admission. The degree of satisfaction of the quality of the service and the care that must be completed before discharge and after surgery will be recorded.

1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure.
Procedure: Outpatient (OA)

Patients who are candidates for OA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision.

Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the OA group (case group), he will be discharged on an outpatient basis from the post-surgical stay unit without requiring hospital admission.
Active Comparator: Hospitalization appendectomy

Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed.

Patients after surgery will go to the anesthetic recovery room and then be admitted to hospital beds, to be discharged within approximately 12 hours.

1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure.
Procedure: Hospitalization appendectomy (HA)

Patients who are candidates for HA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision.

Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the case group (HA), he will be admitted in hospital beds.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rates of ambulatory appendectomy patients that have ambulatory surgery
Time Frame: 20 months
Analyze morbidity of appendectomy patients to determine the safety of ambulatory surgery
20 months
Rates of readmission of appendectomy patients that had ambulatory surgery
Time Frame: 20 months
Analyze rates of readmission of appendectomy patients to determine the safety of ambulatory surgery
20 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of ambulatory appendectomy patients
Time Frame: 20 months

Measure the percentage of ambulatory surgery and uncomplicated acute appendicitis vs the percentage of ambulatory surgery in failure patients with the same pathology e.g.

  • Uncontrolled abdominal pain with analgesia.
  • Upper airway discomfort related to intubation that is not controlled with medication.
  • Pain in the back or shoulders in relation to the pneumoperitoneum that are in patients with not controlled with the medication.
  • Hemodynamically abnormal. Uncontrolled bleeding at the level of any of the wounds. Need for reoperation. Need to re-enter or consult the Emergency Service No spontaneous urination.
  • Nausea / vomiting.
  • Oral intolerance.
  • No wandering.
  • Insecurity or fear of the patient at discharge.
20 months
Media of time until the total incorporation to the activities of the daily life after appendectomy
Time Frame: 20 months
To value the time until the total incorporation to the activities of the daily life after appendectomy.
20 months
Rates of satisfaction
Time Frame: 20 months
Measure the degree of satisfaction of our patients with outpatient management after appendectomy, using a satisfaction questionnaire.
20 months
Costs of the outpatient regimen versus the hospitalization of patients
Time Frame: 20 months
Compare the costs of the outpatient regimen versus the hospitalization of patients with uncomplicated acute appendicitis (cost-minimization analysis).
20 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pareja C Felipe, PhD, Hospital Universitario Virgen del Rocío
  • Study Director: Padillo R Javier, PhD, Hospital Universitario Virgen del Rocío
  • Study Chair: Durán MC Virginia María, MD, Hospital Universitario Virgen del Rocío

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PENDI_CSI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Appendicitis Acute

Clinical Trials on Outpatient (OA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings