APPENDAMBU: Feasibility of Outpatient Appendectomy for Acute Appendicitis

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Completed

CT.gov ID

NCT01839435

Collaborator

(none)

120

Enrollment

Location

Arm

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Acute Appendicitis	Procedure: outpatient surgery	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: outpatient patients

Outpatient surgery will be proposed to all patients

Procedure: outpatient surgery

Outcome Measures

Primary Outcome Measures

success of outpatient appendectomy [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

Secondary Outcome Measures

The unplanned overnight admission rate [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 [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 [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 [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 [postoperative day 30]
The proportion of deprogramming defined as the number of reconvened patients who do not return the next day
post-surgical pain [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 [the day of the surgery prior to the discharge]
the post-surgical quality of life is evaluated thanks to the SF36 Form

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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...)