Clinical trial NCT01839435: Feasibility of Outpatient Appendectomy for Acute Appendicitis
Official title: PROSPECTIVE EVALUATION OF OUTPATIENT APPENDECTOMY FOR NON COMPLICATED ACUTE APPENDICITIS: Intention-to-treat Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Appendicitis
Keywords: appendectomy
acute appendicitis
outpatient
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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 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...)

Primary outcomes:
measure: success of outpatient appendectomy
timeFrame: postoperative day 30
Secondary outcomes:
measure: The unplanned overnight admission rate
timeFrame: postoperative day 30
measure: The unexpected consultation rate
timeFrame: postoperative day 30
measure: The hospital readmission rate
timeFrame: postoperative day 30
measure: the reoperation rate
timeFrame: postoperative day 30
measure: The proportion of deprogramming
timeFrame: postoperative day 30
measure: post-surgical pain
timeFrame: the day of the surgery prior to the discharge
measure: post-surgical quality of life
timeFrame: the day of the surgery prior to the discharge
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
Study officials:
affiliation: CHU amiens
name: jean marc regimbeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sabbagh C, Masseline L, Grelpois G, Ntouba A, Dembinski J, Regimbeau JM. Management of Uncomplicated Acute Appendicitis as Day Case Surgery: Can Outcomes of a Prospective Study Be Reproduced in Real Life? J Am Coll Surg. 2019 Sep;229(3):277-285. doi: 10.1016/j.jamcollsurg.2019.04.031. Epub 2019 May 13.