An interventional study of Ambulatory appendectomy and Conventional appendectomy in Appendicitis, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 33 sites in 2 countries. Open to participants aged 15 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Treatment
The potential benefit of outpatient care for this common digestive emergency is considerable, both for the patients themselves and for the public health system:
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Uncomplicated acute appendicitis confirmed by imaging (ultrasound and/or CT and/or MRI)
Ambulatory criteria
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Ambulatory appendectomy
Procedure: Conventional appendectomy
Appendectomy will be performed in outpatient surgery unit. Patient will be discharge from the hospital the same day as surgery
Appendectomy will be performed in digestive surgery department. Patient will be discharge from the hospital the day after surgery: he will spend a night under observation
To demonstrate that outpatient care, compared with conventional care, in selected patients with acute uncomplicated appendicitis operated by laparoscopy, is non-inferior in terms of overall morbi-mortality on the 30th postoperative day.
Morbi-mortality will be assessed by classifying post-operative complications according to Clavien-Dindo classification. It will be compared between both groups ("ambulatory pathway" versus "conventional hospitalization" CONV) on the 30th postoperative day. The Clavien-Dindo classification was originally published in 2004 in the Annals of Surgery for elective general surgery. Later, it has been objectively validated for all surgical specialties. This classification ranks complications from 0 (no complication) to 5 (death). Complications that potentially lead to long-lasting disability after discharge (e.g.: paralysis of a vocal cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a long-term follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.
Time frame: 30 days post surgery
To compare between both groups, at post-operative day 30, the delay from diagnosis to appendectomy
The delay from diagnosis to appendectomy is defined as the time between the performance of the CT scan (or ultrasound or MRI) for diagnosis and the skin incision in the operating room. This time is expressed in minutes.
Time frame: 30 days post surgery
To compare between both groups, at post-operative day 30, the real cumulated length of hospitalization
The real cumulated length of hospitalization is the cumulative length of the entire hospital stay(s) in hours until the 30th postoperative day (rehospitalizations included). The length of stay in a non-hospital health structure, such as a convalescent center, will not be included.
Time frame: 30 days post surgery
To compare between both groups, at post-operative day 30, the rehospitalization rate
All re-hospitalization(s) after initial discharge will be counted until 30 days post surgery, whatever the cause or type of hospitalization.
Time frame: 30 days post surgery
To compare between both groups, the mild morbidity (Clavien-Dindo I-II) during 30 days post surgery
Post-operative mild morbidity will be assessed with the Clavien-Dindo classification (grade I, II) up to the 30th day post surgery. Clavien-Dindo classification was originally published in 2004 in the Annals of Surgery for elective general surgery. Later, it has been objectively validated for all surgical specialties. This classification ranks complications from 0 (no complication) to 5 (death).
Time frame: up to the 30th day post surgery
To compare between both groups, the severe morbidity (Clavien-Dindo III, IV, V) during 30 days post surgery
Post-operative mild morbidity will be assessed with the severe morbidity (Clavien-Dindo III, IV, V) up to the 30th day post surgery. Clavien-Dindo classification was originally published in 2004 in the Annals of Surgery for elective general surgery. Later, it has been objectively validated for all surgical specialties. This classification ranks complications from 0 (no complication) to 5 (death).
Time frame: up to the 30th day post surgery
To compare between both groups, the rate of interventional radiology re-intervention (radio-guided drainage)
All the Clavien-Dindo interventional radiology re-interventions (radio-guided drainage) performed in relation with the appendicitis and any potential complications will be recorded up to the 30th day post surgery.
Time frame: up to the 30th day post surgery
To compare between both groups, the rate of laparoscopic re-intervention
All laparoscopic re-interventions performed in relation with the appendectomy and the potential complications will be recorded up to the 30th day post surgery.
Time frame: up to the 30th day post surgery
To compare between both groups, at post-operative day 30, the rate of re-intervention by laparotomy
All the laparotomic re-interventions performed in relation with the appendectomy and the potential complications will be recorded up to the 30th day post surgery.
Time frame: up to the 30th day post surgery
To compare between both groups, patient satisfaction 7 and 30 days post surgery
Patient satisfaction will be assessed using a numerical scale from 0 to 10, using the Link4Life app. Zero '0', placed on the left, means that the patient is not satisfied at all with her/his postoperative course; '10', placed on the right, means that the patient is extremely satisfied with her/his postoperative course. If the patient does not have access or does not wish to access Link4Life, a clinical research assistant from the investigating center will collect the patient's satisfaction through a phone call. The questions that will be asked are: "How satisfied are you with your care?"; "are you in pain and if so, how severe is it?"; "Were you worried about same-day discharge (for patients in the outpatient group)?
Time frame: 7 and 30 days post surgery
To compare between both groups, patient quality of life 7 and 30 days post surgery
Quality of life will be evaluated using the EuroQol five-dimension questionnaire (EQ-5D-5L), at inclusion, and at 7 and 30 days post surgery.The EQ-5D-5L comprises a descriptive system and a visual analogue scale (VAS). The descriptive system is composed of five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels of health (no problems, slight problems, moderate problems, severe problems and extreme problems). For each of the 5 dimensions, the participant's answer is converted to a number between 1 and 5, expressing the health state reported. The responses are combined to produce a five-digit number describing the participant's health status which is converted to a utility value from the country specific value set. The French EQ-5D-5L value set has utility between -0.530 (health condition worse than death) and 1 (best possible health). The VAS records the self-rated health status on a graduated scale from 0 to 100.
Time frame: at inclusion and at 7 and 30 days post surgery
To evaluate the rate of conversion from outpatient to conventional care
A conversion will be defined as a patient randomized to the outpatient care group who is finally treated following the conventional care procedure, whatever the reason
Time frame: up to the 30th day post surgery
To estimate the cost of outpatient appendectomy management
The cost will be estimated by the hospital cost (intervention and outpatient stay).
Time frame: up to the 30th day post surgery
To study the economic impact (utility) of outpatient appendectomy management compared to conventional hospitalization
The economic impact will be studied with a cost-utility analysis which will estimate the incremental cost-effectiveness ratio (ICER) in cost per QALY (quality adjusted life years) gained.
Time frame: up to the 30th day post surgery
To study the economic impact (effectiveness) of outpatient appendectomy management compared to conventional hospitalization
The economic impact will be studied with a cost-effectiveness analysis which will estimate the ICER in cost per patient without rehospitalization.
Time frame: up to the 30th day post surgery
To study the generalization of outpatient appendectomy management in all French hospitals at the budgetary level
The generalization of outpatient appendectomy management will be studied with a budget impact model which will estimate the consequences in terms of costs
Time frame: up to the 30th day post surgery
To study the generalization of outpatient appendectomy management in all French hospitals at a strategic level
The generalization of outpatient appendectomy management will be studied with QALYs (quality adjusted life years) of the adoption of the outpatient strategy in all French hospitals
Time frame: up to the 30th day post surgery
Started Jul 2023 (actual). Primary completion is estimated for Jan 2028, 54 months after the start.
Of 89 non-industry interventional studies with no phase under Appendicitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 54 months is above that.
Counting every sponsor, half of 91 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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