Acute AppendicitisPhase 3APPENDAMBUNCT01839435
Feasibility of Outpatient Appendectomy for Acute Appendicitis
A Phase 3 study testing outpatient surgery in people with Acute Appendicitis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- outpatient surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Mar 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Less than one hour from an health care adapted to the surgical structure
- Quick access to a telephone
- Patient affiliated with social protection
Who cannot join
- 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...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROSPECTIVE EVALUATION OF OUTPATIENT APPENDECTOMY FOR NON COMPLICATED ACUTE APPENDICITIS: Intention-to-treat Study
The aim of our monocentric prospective in intention-to-treat study is to evaluate the feasibility of outpatient appendectomy for non complicated acute appendicitis.
Read the 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.
- Conditions
- Acute Appendicitis
- Being tested
- outpatient surgery
- Keywords
- appendectomy, acute appendicitis, outpatient
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outpatient surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| outpatient patients | Experimental | Outpatient surgery will be proposed to all patients Receives: Procedure: outpatient surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: postoperative day 30
Secondary outcomes (7)
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
Measured: postoperative day 30
The unexpected consultation rate
The unexpected consultation rate reflects the number of AS patients attending the emergency department for a postoperative problem.
Measured: postoperative day 30
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
Measured: postoperative day 30
the reoperation rate
the reoperation rate reflects the proportion of patients who are operated on after their post-outpatient surgery discharge
Measured: postoperative day 30
The proportion of deprogramming
The proportion of deprogramming defined as the number of reconvened patients who do not return the next day
Measured: postoperative day 30
post-surgical pain
the post-surgical pain is evaluated thanks to the Brief Pain Inventory Form
Measured: the day of the surgery prior to the discharge
post-surgical quality of life
the post-surgical quality of life is evaluated thanks to the SF36 Form
Measured: the day of the surgery prior to the discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean marc regimbeau, MD, PhD, Principal investigator, CHU amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839435
- Sponsor's protocol ID
- PI2012_843_0031
- Other IDs
- 2013-A00170-45, 120202B-42
- Acronym
- APPENDAMBU
- Status last verified
- Sep 2025
- First submitted
- 22 Apr 2013
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22441976Sabbagh 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.
PubMed 31096041
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE EVALUATION OF OUTPATIENT APPENDECTOMY FOR NON COMPLICATED ACUTE APPENDICITIS: Intention-to-treat Study
- ClinicalTrials.gov ID
- NCT01839435
- Acronym / sponsor ID
- APPENDAMBU / PI2012_843_0031
- Conditions
- Acute Appendicitis
- Keywords
- appendectomy, acute appendicitis, outpatient
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| outpatient patients | Experimental | Procedure: outpatient surgeryOutpatient surgery will be proposed to all patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- complicated appendicitis
- pregnancy or breastfeeding
- unstable vital signs or fever
- objective signs of diffuse peritonitis
- ward of court or prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| outpatient surgery | Procedure or surgery | outpatient patients |
Primary outcome
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
7 secondary outcomes
The unplanned overnight admission rate
Time frame: postoperative day 30
The unexpected consultation rate
Time frame: postoperative day 30
The hospital readmission rate
Time frame: postoperative day 30
the reoperation rate
Time frame: postoperative day 30
The proportion of deprogramming
Time frame: postoperative day 30
post-surgical pain
Time frame: the day of the surgery prior to the discharge
post-surgical quality of life
Time frame: the day of the surgery prior to the discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Background: PubMed 22441976Sabbagh 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.
- Results publication: PubMed 31096041Sabbagh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jean marc regimbeau, MD, PhD principal investigator
CHU amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing outpatient surgery in people with Acute Appendicitis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of outpatient appendectomy (time frame: postoperative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01839435, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.