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

Multicentre randomised, double-blind, controlled trial of laparoscopic versus open surgery for suspected appendicitis in adults

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42332281

Enrollment

386

Registered

2005-10-05

Start date

2006-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspected acute appendicitis Digestive System Acute appendicitis

Interventions

Laparoscopic appendectomy (LA) versus conventional open appendectomy (OA)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult (from 18 years old) patients with symptoms and signs of acute appendicitis, any gender.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Post-operative pain (cm visual analogue scale [VAS], number of analgesic doses)	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026