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

Randomized Controlled Trial Comparing Single Incision Laparoscopic Appendectomy Versus Standard Three Port Appendectomy in a Selected Cohort of Patients

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.

Study Overview

• Status: Unknown
• Conditions: Acute Appendicitis
• Intervention / Treatment: Procedure: Single incision laparoscopic appendectomy; Procedure: Multiport laparoscopic appendectomy

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nereo Vettoretto, MD; Phone Number: 00393492237383; Email: nereovet@gmail.com

Study Locations

• Italy
  • BS
    • Chiari, BS, Italy, 25032
      • M.Mellini Hospital
      • Principal Investigator: Nereo Vettoretto, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single incision laparoscopic appendectomy; Acute appendicitis with surgical indication	Procedure: Single incision laparoscopic appendectomy; A multiport device will be introducted through a 2-2.5 transumbilical incision. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.; Other Names: SILA
Active Comparator: Multiport Laparoscopic appendectomy; Acute appendicitis with surgical indication	Procedure: Multiport laparoscopic appendectomy; Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.; Other Names: LA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Morbidity and mortality	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Associazione Chirurghi Ospedalieri Italiani
• Collaborators: Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)
• Investigators: Study Chair: Nereo Vettoretto, MD, ACOI - SICE; Study Chair: Ferdinando Agresta, MD, ACOI - SICE; Study Chair: Luigi Boni, MD, FACS, SICE

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: October 31, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (Estimate): November 2, 2012

Study Record Updates

• Last Update Posted (Estimate): November 4, 2012
• Last Update Submitted That Met QC Criteria: November 2, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: ACOI - SICE