Feasibility of Outpatient Appendectomy for Acute Appendicitis

NCT ID: NCT01839435

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-03-31

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.

Conditions

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Acute Appendicitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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outpatient patients

Outpatient surgery will be proposed to all patients

Group Type EXPERIMENTAL

outpatient surgery

Intervention Type PROCEDURE

Interventions

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outpatient surgery

Intervention Type PROCEDURE

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...)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jean marc regimbeau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU amiens

Locations

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Amiens University Hospital

Amiens, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 22441976 (View on PubMed)

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.

Reference Type RESULT
PMID: 31096041 (View on PubMed)

Other Identifiers

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2013-A00170-45

Identifier Type: OTHER

Identifier Source: secondary_id

120202B-42

Identifier Type: OTHER

Identifier Source: secondary_id

PI2012_843_0031

Identifier Type: -

Identifier Source: org_study_id

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