Laparoscopic Excision versus OpeN Appendectomy multicentre Randomised, DOuble blind, controlled trial

ISRCTN	ISRCTN42332281
DOI	https://doi.org/10.1186/ISRCTN42332281
Protocol serial number	118/2005/U
Sponsor	Sant'Orsola-Malpighi University Hospital Bologna (Italy)
Funder	Sant'Orsola-Malpighi University Hospital of Bologna (Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi) (Italy)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Luca Ansaloni
Scientific

Unit of Emergency Surgery
Sant'Orsola-Malpighi Hospital
Via Massarenti 9
Bologna
40138
Italy

Phone	+39 (0)328 9128533
Email	lansaloni@orsola-malpighi.med.unibo.it

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Multicentre randomised, double-blind, controlled trial of laparoscopic versus open surgery for suspected appendicitis in adults
Study acronym	LEONARDO
Study objectives	To compare the therapeutic effects of laparoscopic appendectomy (LA) and conventional open appendectomy (OA) in the treatment of suspected acute appendicitis.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Suspected acute appendicitis
Intervention	Laparoscopic appendectomy (LA) versus conventional open appendectomy (OA)
Intervention type	Other
Primary outcome measure(s)	Post-operative pain (cm visual analogue scale [VAS], number of analgesic doses)
Key secondary outcome measure(s)	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)
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	386
Key inclusion criteria	Adult (from 18 years old) patients with symptoms and signs of acute appendicitis, any gender.
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	31/12/2007

Unit of Emergency Surgery

Bologna
40138
Italy

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan