Condition category
Digestive System
Date applied
04/08/2005
Date assigned
05/10/2005
Last edited
27/04/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes