Laparoscopic Appendectomy by Multi-port vs Single Port.

Phase 3

• Conditions: Acute Appendicitis
• Interventions: Procedure: Single incision laparoscopic appendectomy; Procedure: Multiport laparoscopic appendectomy

• Registration Number: NCT01720082
• Lead Sponsor: Associazione Chirurghi Ospedalieri Italiani

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-10-31
• Status Verified: 2012-11
• Study First Posted: 2012-11-02
• Last Update Submitted: 2012-11-02
• Last Update Posted: 2012-11-04
• Study Start: 2013-03
• Primary Completion: 2013-08
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single incision laparoscopic appendectomy	Single incision laparoscopic appendectomy	Acute appendicitis with surgical indication
Multiport Laparoscopic appendectomy	Multiport laparoscopic appendectomy	Acute appendicitis with surgical indication

Primary Outcome Measures

Name	Time	Method
Morbidity and mortality	30 days

Secondary Outcome Measures

Name	Time	Method
Cosmetic result	6 months	VAS scale
Incision related morbidity	6 months	during hospital stay (7days): infectious morbidity during follow-up (6 months): incisional hernias
Quality of life	6 months	Gastro Intestinal Quality of Life Index (GIQLI) score at discharge and at 6 months follow-up
Post-operative pain score	3 days	Visual Analogic Scale (VAS scale)
Operative time	1 day
Post-operative hospital stay	7 days

Trial Locations

Locations (1)

M.Mellini Hospital; 🇮🇹 Chiari, BS, Italy