Laparoscopic Appendectomy by Multi-port vs Single Port.

Acute Appendicitis Clinical Trial

— AMUSING  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01720082
• Other study ID #: ACOI - SICE
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 31, 2012
• Last updated: November 2, 2012
• Start date: March 2013
• Est. completion date: February 2014

Study information

• Verified date: November 2012
• Source: Associazione Chirurghi Ospedalieri Italiani
• Contact: Nereo Vettoretto, MD
• Phone: 00393492237383
• Email: nereovet[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: February 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	M.Mellini Hospital	Chiari	BS

Sponsors (2)

Lead Sponsor	Collaborator
Associazione Chirurghi Ospedalieri Italiani	Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity and mortality		30 days	Yes
Secondary	Post-operative pain score	Visual Analogic Scale (VAS scale)	3 days	No
Secondary	Operative time		1 day	No
Secondary	Cosmetic result	VAS scale	6 months	No
Secondary	Post-operative hospital stay		7 days	No
Secondary	Incision related morbidity	during hospital stay (7days): infectious morbidity during follow-up (6 months): incisional hernias	6 months	Yes
Secondary	Quality of life	Gastro Intestinal Quality of Life Index (GIQLI) score at discharge and at 6 months follow-up	6 months	No