Laparoscopic Excision versus OpeN Appendectomy multicentre Randomised, DOuble blind, controlled trial
| ISRCTN | ISRCTN42332281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42332281 |
| Secondary identifying numbers | 118/2005/U |
- Submission date
- 04/08/2005
- Registration date
- 05/10/2005
- Last edited
- 27/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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
Contact information
Dr Luca Ansaloni
Scientific
Scientific
Unit of Emergency Surgery
Sant'Orsola-Malpighi Hospital
Via Massarenti 9
Bologna
40138
Italy
| Phone | +39 (0)328 9128533 |
|---|---|
| lansaloni@orsola-malpighi.med.unibo.it |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/01/2006 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 386 (193 patients for each group) |
| 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 |
Locations
Countries of recruitment
- Italy
Study participating centre
Unit of Emergency Surgery
Bologna
40138
Italy
40138
Italy
Sponsor information
Sant'Orsola-Malpighi University Hospital Bologna (Italy)
Hospital/treatment centre
Hospital/treatment centre
Via Massarenti 9
Bologna
40138
Italy
| Phone | +39 (0)51 6361111 |
|---|---|
| cometico@aosp.bo.it |
Funders
Funder type
Hospital/treatment centre
Sant'Orsola-Malpighi University Hospital of Bologna (Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi) (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
