Laparoscopic Appendectomy by Multi-port vs Single Port. (AMUSING)

Associazione Chirurghi Ospedalieri Italiani

Status and phase: Unknown; Phase 3

Conditions: Acute Appendicitis

Treatments: Procedure: Single incision laparoscopic appendectomy; Procedure: Multiport laparoscopic appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01720082

ACOI - SICE

Details and patient eligibility

About

Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this subgroup is high. Since the dissemination of single access surgery (no-scars surgery) ameliorated outcome has been supposed in these patients regarding post-operative pain, hospital stay and cosmetics results, and keeping the same safety as LA. This randomized controlled study is supposed to give answers to these questions.

Enrollment: 300 estimated patients

Sex: Female

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age: 14-60
• American Society of Anesthesiologists (ASA) score: I-III
• absence of non-correctable coagulopathy (international normalized ratio >1,5, or platelet count <90 × 109/l).
• diagnosis: acute appendicitis with surgical indication

Exclusion criteria

• Complicated appendicitis after exploration or previously diagnosed (CT)
• Psychical inability
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

300 participants in 2 patient groups

Single incision laparoscopic appendectomy

Active Comparator group

Description:

Acute appendicitis with surgical indication

Treatment:

Procedure: Single incision laparoscopic appendectomy

Multiport Laparoscopic appendectomy

Active Comparator group

Description:

Acute appendicitis with surgical indication

Treatment:

Procedure: Multiport laparoscopic appendectomy