NCT01839435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

2.8 years

First QC Date

April 22, 2013

Last Update Submit

September 17, 2025

Conditions

Acute Appendicitis

Keywords

appendectomyacute appendicitisoutpatient

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • The unplanned overnight admission rate

    postoperative day 30

  • The unexpected consultation rate

    postoperative day 30

  • The hospital readmission rate

    postoperative day 30

  • the reoperation rate

    postoperative day 30

  • The proportion of deprogramming

    postoperative day 30

  • +2 more secondary outcomes

Study Arms (1)

outpatient patients

EXPERIMENTAL

Outpatient surgery will be proposed to all patients

Procedure: outpatient surgery

Interventions

outpatient surgeryPROCEDURE
outpatient patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amiens University Hospital

Amiens, France

Location

Related Publications (2)

  • 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.

    PMID: 22441976BACKGROUND

  • 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.

    PMID: 31096041RESULT

MeSH Terms

Conditions

Appendicitis

Interventions

Ambulatory Surgical Procedures

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • jean marc regimbeau, MD, PhD

    CHU amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 24, 2013

Study Start

April 1, 2013

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations

FR(1)