Feasibility of Outpatient Appendectomy for Acute Appendicitis (APPENDAMBU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Centre Hospitalier Universitaire, Amiens
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01839435
First received: April 22, 2013
Last updated: November 26, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Acute Appendicitis
Procedure: outpatient surgery
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: PROSPECTIVE EVALUATION OF OUTPATIENT APPENDECTOMY FOR NON COMPLICATED ACUTE APPENDICITIS: Intention-to-treat Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • success of outpatient appendectomy [ Time Frame: postoperative day 30 ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • The unplanned overnight admission rate [ Time Frame: postoperative day 30 ] [ Designated as safety issue: Yes ]
    the proportion of patients who are discharged more than 12 hours after the surgery and are thus hospitalized for at least one night

  • The unexpected consultation rate [ Time Frame: postoperative day 30 ] [ Designated as safety issue: Yes ]
    The unexpected consultation rate reflects the number of AS patients attending the emergency department for a postoperative problem.

  • The hospital readmission rate [ Time Frame: postoperative day 30 ] [ Designated as safety issue: Yes ]
    The hospital readmission rate is defined as the number of patients who are discharged from hospital after outpatient surgery but are subsequently readmitted

  • the reoperation rate [ Time Frame: postoperative day 30 ] [ Designated as safety issue: Yes ]
    the reoperation rate reflects the proportion of patients who are operated on after their post-outpatient surgery discharge

  • The proportion of deprogramming [ Time Frame: postoperative day 30 ] [ Designated as safety issue: Yes ]
    The proportion of deprogramming defined as the number of reconvened patients who do not return the next day

  • post-surgical pain [ Time Frame: the day of the surgery prior to the discharge ] [ Designated as safety issue: Yes ]
    the post-surgical pain is evaluated thanks to the Brief Pain Inventory Form

  • post-surgical quality of life [ Time Frame: the day of the surgery prior to the discharge ] [ Designated as safety issue: Yes ]
    the post-surgical quality of life is evaluated thanks to the SF36 Form


Estimated Enrollment: 120
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: outpatient patients
Outpatient surgery will be proposed to all patients
Procedure: outpatient surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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...)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839435

Contacts
Contact: jean marc regimbeau, MD, phD +33 3 22 66 83 00 regimbeau.jean-marc@chu-amiens.fr

Locations
France
Amiens University Hospital Recruiting
Amiens, France
Contact: jean marc regimbeau, MD, PhD    +33 3 22 66 83 00    regimbeau.jean-marc@chu-amiens.fr   
Sub-Investigator: charles sabbagh, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: jean marc regimbeau, MD, PhD CHU amiens
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01839435     History of Changes
Other Study ID Numbers: PI2012_843_0031, 2013-A00170-45, 120202B-42
Study First Received: April 22, 2013
Last Updated: November 26, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Hospitalier Universitaire, Amiens:
appendectomy
acute appendicitis
outpatient

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2014