Feasibility of Outpatient Appendectomy for Acute Appendicitis

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

Detailed Description
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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.

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

Conditions
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Acute Appendicitis

Intervention / Treatment
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* Procedure: outpatient surgery


Participation Criteria
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Eligibility Criteria
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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...)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: outpatient patients<br>Outpatient surgery will be proposed to all patients | Procedure: outpatient surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success of outpatient appendectomy | 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 | 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 | 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 | 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 | 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 | The proportion of deprogramming defined as the number of reconvened patients who do not return the next day | postoperative day 30 | 
| post-surgical pain | 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 | the post-surgical quality of life is evaluated thanks to the SF36 Form | the day of the surgery prior to the discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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appendectomy, acute appendicitis, outpatient