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Completed

NCT Number: NCT01839435

Feasibility of Outpatient Appendectomy for Acute Appendicitis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Amiens University Hospital

Amiens, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

outpatient surgery

Procedure

Primary outcomes

  1. success of outpatient appendectomy

    Time frame: 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 outcomes

  1. The unplanned overnight admission rate

    Time frame: 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

  2. The unexpected consultation rate

    Time frame: postoperative day 30

    The unexpected consultation rate reflects the number of AS patients attending the emergency department for a postoperative problem.

  3. The hospital readmission rate

    Time frame: 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

  4. the reoperation rate

    Time frame: postoperative day 30

    the reoperation rate reflects the proportion of patients who are operated on after their post-outpatient surgery discharge

  5. The proportion of deprogramming

    Time frame: postoperative day 30

    The proportion of deprogramming defined as the number of reconvened patients who do not return the next day

  6. post-surgical pain

    Time frame: the day of the surgery prior to the discharge

    the post-surgical pain is evaluated thanks to the Brief Pain Inventory Form

  7. post-surgical quality of life

    Time frame: the day of the surgery prior to the discharge

    the post-surgical quality of life is evaluated thanks to the SF36 Form

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: APPENDAMBU

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 24, 2013
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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