Feasibility of Outpatient Appendectomy for Acute Appendicitis (APPENDAMBU)
|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|
- 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
- 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
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: outpatient patients
Outpatient surgery will be proposed to all patients
|Procedure: outpatient surgery|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01839435
|Contact: jean marc regimbeau, MD, phD||+33 3 22 66 83 firstname.lastname@example.org|
|Amiens University Hospital||Recruiting|
|Contact: jean marc regimbeau, MD, PhD +33 3 22 66 83 00 email@example.com|
|Sub-Investigator: charles sabbagh, MD|
|Principal Investigator:||jean marc regimbeau, MD, PhD||CHU amiens|