Appendectomy Versus Conservative Treatment for Uncomplicated Acute Appendicitis

Acute Appendicitis Clinical Trial

— ACTUAA  

Official title:

A Prospective Non-randomized Controlled, Multicenter, Multidisciplinary Trial Comparing Appendectomy and Conservative Treatment for Patients With Uncomplicated Acute Appendicitis (the ACTUAA STUDY).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080103
• Other study ID #: No ID
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Associazione Chirurghi Ospedalieri Italiani
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

On September the 15th, 2015, Italian surgeons, radiologists and pathologists with a special interest and expertise in the diagnosis and management of Acute Appendicitis (AA), met up under the auspices of the Italian Society of Hospital Surgeons (ACOI) in Oristano (Italy) to constitute the ACTUAA collaborative working group. The main objectives of the working group are:

To create a working basis for analyzing the diagnostic features, treatment modalities and outcomes of interest of both the antibiotic-first approach and appendectomy for patients with uncomplicated AA.

To investigate the clinical, laboratory and radiologic modalities adopted for the diagnosis To determine the outcomes of patients treated with antibiotics or appendectomy in the short and long term periods.

To compare results according to the type of intervention. To stratify the risk of recurrence for patients treated with antibiotics according to clinical, laboratory and radiology findings.

To evaluate the sensibility and specificity of clinical and laboratory scores for the diagnosis of uncomplicated AA.

To identify a subgroup of patients with uncomplicated AA for whom antibiotic treatment can be highly effective.

General study design The study protocol is designed according to the "SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials".

The study period is estimated to be of 12 month + 12 month of follow-up (with a second session of follow-up following 5-years), beginning on 01/04/2017.

Participants All adult patients (aged over 18 years old) with suspected AA will be admitted to the Surgical Department of the nine participating Italian hospitals, where they will be studied carefully by the on call surgeon.

Patients will be then informed of the study protocol and invited to give written consent for participation and for sensible data collection for scientific purposes.

Subsequently, only patients who will undergo diagnostic imaging (as specified later) and from whom a written informed consent will be obtained, can be enrolled in the study and registered by each Center using a uniform electronic registration form and database.

General characteristics, medical history, clinical findings, physical investigation, and blood tests will be reported in the medical record. Pain will be quantified by Visual Analogue Scale (VAS) scoring system before administrating any pain medications and after the treatments.

In order to enter the study, patients will have to undergo diagnostic imaging (US and/or CT scan or MRI scan) and only the diagnosis of uncomplicated AA confirmed by diagnostic imaging will permit patient enrollment in the study.

Specific aims of the ACTUAA Study The objective of this prospective non-randomized controlled, multicenter, multidisciplinary trial is to compare the antibiotic therapy and emergency appendectomy for the treatment of patients with uncomplicated AA(without abscess or free perforation), confirmed by US and/or CT or MRI scan. No changes in the daily practice regarding the diagnostic, clinical and treatment pathways will be required to the participating centers. However, only the patients with uncomplicated AA, confirmed by one of the above mentioned radiologic tools will be enrolled in the study. The decision on which of the tools are to be adopted will be up to the local lead surgeon.

Primary Outcome Measure:

Number of participants with complication-free treatment success, defined as success of the initial treatment with uncomplicated course.

Secondary Outcome Measures:

Length of hospital stay; Pain evaluation; Time to return to normal activity; Period of sick-leave; Complicated appendicitis with peritonitis identified at the time of surgical operation; Quality of life as assessed by the Short Form 12-scale (SF-12)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Age over 18 years

• Uncomplicated AA confirmed by US and/or CT or MRI scan.

Exclusion Criteria:

• Pregnancy or lactating

• Diffuse peritonitis at physical examination

• Serious systemic illness

• Positive anamnesis for Inflammatory Bowel Disease (IBD)

Related Conditions & MeSH terms

• Acute Appendicitis
• Acute Disease
• Antibiotic Therapy
• Appendectomy
• Appendicitis
• Appendicitis Recurrent

Intervention

Procedure:
• Laparoscopic or Open appendectomy
Laparoscopic three-port or single-port appendectomy; or conventional McBurney laparotomic appendectomy; or open appendectomy performed through midline incision

Drug:
• Antibiotic-first therapy
Patients treated with antibiotics as first-line approach

Locations

Country	Name	City	State
Italy	General and Endocrine Surgical Unit, Cagliari University Hospital, Cagliari	Cagliari
Italy	General Surgery, Santissima Trinità Hospital	Cagliari
Italy	General Surgery Unit, Nostra Signora Della Mercede Hospita, Lanusei	Lanusei	Ogliastra
Italy	General and Emergency Surgery Unit, San Marcellino Hospital	Muravera	Cagliari
Italy	Emergency Surgery Unit, Villa Betania Evangelic Hospital, Napoli	Napoli
Italy	General, Minimally Invasive and Robotic Surgery, San Francesco Hospital	Nuoro
Italy	Department of General Surgery, San Giovanni Addolorata Hospital	Rome	Italt

Sponsors (2)

Lead Sponsor	Collaborator
Mauro Podda	Associazione Chirurghi Ospedalieri Italiani

Country where clinical trial is conducted

Italy, 

References & Publications (43)

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with complication-free treatment success, as assessed by the Dindo-Clavien Scale.	Number of participants with complication-free treatment success, defined as success of the initial treatment with uncomplicated course: no postoperative complications, adverse events, or treatment failure occurring, as assessed by the Dindo-Clavien Classification. Post-treatment abdominal abscess, bowel occlusion, incisional hernia, pulmonary embolism, cardio-vascular complications, surgical site infection, complications due to anesthesia, adverse reactions to antibiotics. Complications are analyzed both for patients submitted to appendectomy and for those treated with surgery as second line approach, after primary antibiotic treatment failure. For patients treated with antibiotics, treatment failure (persistency and recurrence rates of acute appendicitis) will be evaluated within the overall-complications rate. Specific sub-analyses of the complications will be carried out.	1 year
Secondary	Length of hospital stay	Length of post-operative hospital stay for patients submitted to appendectomy; length of hospital stay for patients treated with antibiotics	1 week
Secondary	VAS-Score	Pain evaluation performed through the visual analogue scale both for patients who undergo an appendectomy and for those treated with antibiotics	1 month
Secondary	Time to return to normal activity	Time to return to normal activity both for patients who undergo an appendectomy and for those treated with antibiotics	1 month
Secondary	Period of sick-leave	Period of sick-leave, intended as "absence from work"	1 month
Secondary	Complicated appendicitis with peritonitis identified at the time of surgical operation.	In the antibiotic group the analysis will be carried out within the cohort of patients who will undergo appendectomy after the failure of the antibiotic therapy in order to assess whether or not a major risk of perforated appendicitis exists for patients who will be treated firstly with antibiotics.	1 year
Secondary	Quality of life as assessed by the Short Form 12-scale (SF-12)	Quality of life estimated by the Short Form 12-scale (SF-12)	1 year