Feasibility of Outpatient Appendectomy for Acute Appendicitis

Acute Appendicitis Clinical Trial

— APPENDAMBU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839435
• Other study ID #: PI2012_843_0031
• Secondary ID: 2013-A00170-4512
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2013
• Last updated: April 27, 2016
• Start date: April 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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...)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Appendicitis
• Acute Disease
• Appendicitis

Intervention

Procedure:
• outpatient surgery

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	the reoperation rate	the reoperation rate reflects the proportion of patients who are operated on after their post-outpatient surgery discharge	postoperative day 30	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes