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Feasibility of Outpatient Appendectomy for Acute Appendicitis (APPENDAMBU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01839435
First Posted: April 24, 2013
Last Update Posted: April 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
April 22, 2013
April 24, 2013
April 28, 2016
April 2013
February 2016   (Final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01839435 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
Same as current
Not Provided
Not Provided
 
Feasibility of Outpatient Appendectomy for Acute Appendicitis
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.

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.

Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Acute Appendicitis
Procedure: outpatient surgery
Experimental: outpatient patients
Outpatient surgery will be proposed to all patients
Intervention: Procedure: outpatient surgery
Sabbagh C, Brehant O, Dupont H, Browet F, Pequignot A, Regimbeau JM. The feasibility of short-stay laparoscopic appendectomy for acute appendicitis: a prospective cohort study. Surg Endosc. 2012 Sep;26(9):2630-8. doi: 10.1007/s00464-012-2244-1. Epub 2012 Mar 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2016
February 2016   (Final data collection date for primary outcome measure)

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...)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01839435
PI2012_843_0031
2013-A00170-45 ( Other Identifier: ID-RCB )
120202B-42 ( Other Identifier: french ANSM )
No
Not Provided
Not Provided
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier Universitaire, Amiens
Not Provided
Principal Investigator: jean marc regimbeau, MD, PhD CHU amiens
Centre Hospitalier Universitaire, Amiens
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP