Contact information
Type
Scientific
Primary contact
Dr Luca Ansaloni
ORCID ID
Contact details
Unit of Emergency Surgery
Sant'Orsola-Malpighi Hospital
Via Massarenti 9
Bologna
40138
Italy
+39 (0)328 9128533
lansaloni@orsola-malpighi.med.unibo.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
118/2005/U
Study information
Scientific title
Multicentre randomised, double-blind, controlled trial of laparoscopic versus open surgery for suspected appendicitis in adults
Acronym
LEONARDO
Study hypothesis
To compare the therapeutic effects of laparoscopic appendectomy (LA) and conventional open appendectomy (OA) in the treatment of suspected acute appendicitis.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Suspected acute appendicitis
Intervention
Laparoscopic appendectomy (LA) versus conventional open appendectomy (OA)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Post-operative pain (cm visual analogue scale [VAS], number of analgesic doses)
Secondary outcome measures
1. Wound infections (rate)
2. Intra-abdominal abscesses (rate)
3. Duration of operation (minutes), defined as operating time, anaesthesia time, or operating room time
4. Length of hospital stay (days/hours)
5. Return to normal activity (days), subdivided in: time until return to full activity, work, or sport
6. Return of bowel function (hours), subdivided in: time until first stool, introduction of liquid or solid diet
7. Cosmesis (cm VAS, number of analgesic doses)
Overall trial start date
01/01/2006
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult (from 18 years old) patients with symptoms and signs of acute appendicitis, any gender.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
386 (193 patients for each group)
Participant exclusion criteria
1. Refusing of informed consent
2. Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient)
3. Patients with contraindication to be operated with either LA (to be stated), or OA (to be stated) will be excluded from the study
4. American Society of Anaesthesiologists (ASA) grade IV or V
5. Not fluent Italian speakers
Recruitment start date
01/01/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Italy
Trial participating centre
Unit of Emergency Surgery
Bologna
40138
Italy
Sponsor information
Organisation
Sant'Orsola-Malpighi University Hospital Bologna (Italy)
Sponsor details
Via Massarenti 9
Bologna
40138
Italy
+39 (0)51 6361111
cometico@aosp.bo.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Sant'Orsola-Malpighi University Hospital of Bologna (Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi) (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list