NCT01720082

Laparoscopic Appendectomy by Multi-port vs Single Port.

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Associazione Chirurghi Ospedalieri Italiani · Academic / Other
• Sex: Female
• Age: 14 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Appendicitis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-08-01
• Completion: 2014-02-01
• First posted: 2012-11-02
• Last updated: 2012-11-05

Locations

1 site across 1 country: Italy