Feasibility of Outpatient Appendectomy for Acute Appendicitis (APPENDAMBU)

April 27, 2016 updated by: Centre Hospitalier Universitaire, Amiens

PROSPECTIVE EVALUATION OF OUTPATIENT APPENDECTOMY FOR NON COMPLICATED ACUTE APPENDICITIS: Intention-to-treat Study

The aim of our monocentric prospective in intention-to-treat study is to evaluate the feasibility of outpatient appendectomy for non complicated acute appendicitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute appendicitis is one of the most common surgical emergencies and corresponds to an high number of admissions (about 120.000) in France. It mainly affects young adults and is associated to fewer complications and to a short length of stay. The notion of outpatient refers to a shorter hospital length to stay i.e. less than 12 hours without an overnight hospitalization. This notion came from 3 learned society recommendations' (SFCD, ACHBT, and AFCA) and has been considered as a national priority.

There is no consensus about appendectomy in an outpatient setting.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

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

  • France
      • Amiens, France
        • Amiens University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non complicated acute appendicitis which has been diagnosed at physical, paraclinical and morphological examination
  • Adult patient
  • Patient with sufficient understanding
  • Good compliance with medical prescription
  • Hygiene and housing equivalent to a hospitalization
  • Availability of an accompanying able to prevent the surgeon if necessary, to accompany the patient and stay at night next to him
  • Less than one hour from an health care adapted to the surgical structure
  • Quick access to a telephone
  • Patient affiliated with social protection

Exclusion Criteria:

  • complicated appendicitis
  • pregnancy or breastfeeding
  • unstable vital signs or fever
  • objective signs of diffuse peritonitis
  • ward of court or prisoners
  • Discovery of a complicated shape (severe sepsis, abscess, generalized peritonitis)
  • Discovery of an alternative diagnosis
  • Performing an associated gesture (colectomy or typhlectomy, annexectomy...)

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: outpatient patients
Outpatient surgery will be proposed to all patients
Procedure: outpatient surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success of outpatient appendectomy
Time Frame: postoperative day 30

The primary endpoint corresponds to the proportion of outpatient appendectomy defined as the number of patients whose hospital length of stay is less than 12 hours.

This endpoint will be evaluated during the consult 30 day after the surgery
postoperative day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The unplanned overnight admission rate
Time Frame: postoperative day 30
the proportion of patients who are discharged more than 12 hours after the surgery and are thus hospitalized for at least one night
postoperative day 30
The unexpected consultation rate
Time Frame: postoperative day 30
The unexpected consultation rate reflects the number of AS patients attending the emergency department for a postoperative problem.
postoperative day 30
The hospital readmission rate
Time Frame: postoperative day 30
The hospital readmission rate is defined as the number of patients who are discharged from hospital after outpatient surgery but are subsequently readmitted
postoperative day 30
the reoperation rate
Time Frame: postoperative day 30
the reoperation rate reflects the proportion of patients who are operated on after their post-outpatient surgery discharge
postoperative day 30
The proportion of deprogramming
Time Frame: postoperative day 30
The proportion of deprogramming defined as the number of reconvened patients who do not return the next day
postoperative day 30
post-surgical pain
Time Frame: the day of the surgery prior to the discharge
the post-surgical pain is evaluated thanks to the Brief Pain Inventory Form
the day of the surgery prior to the discharge
post-surgical quality of life
Time Frame: the day of the surgery prior to the discharge
the post-surgical quality of life is evaluated thanks to the SF36 Form
the day of the surgery prior to the discharge

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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

April 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2012_843_0031
  • 2013-A00170-45 (Other Identifier: ID-RCB)
  • 120202B-42 (Other Identifier: french ANSM)

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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