NCT01643018

Laparoscopic Versus Open Surgery for the Management of Cystic Echinococcosis of the Liver

Laparoscopic Versus Open Conservative Surgery for the Management of Cystic Echinococcosis of the Liver: Prospective, Randomized, and Controlled Clinical Trial of Efficacy and Safety

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Medical Park Gaziantep Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Echinococcosis in humans is a parasitic tapeworm infection, caused by a larval stage (the metacestode) of Echinococcus species. The infection can be asymptomatic or severe, causing extensive organ damage and even death of the patient. Echinococcosis is one of the most neglected parasitic diseases and the lack of the prospective randomised studies supports this idea. Development of new drugs and other treatment modalities receives very little attention, if any. In most developed countries, Cystic Echinococcosis (CE) is an imported disease of very low incidence and prevalence and is found almost exclusively in migrants from endemic regions. In endemic regions, predominantly settings with limited resources, patient numbers are high. The aim of the hydatid cyst treatment is the death of the parasite and consequently the cure of the disease. It has to be done with a minimal risk and maximum comfort for the patient, and always paying attention to avoid complications, secondary hydatidosis, and relapses. There are several treatment modalities. Of them the most preferred surgical method is traditional cyst management through a laparotomy incision. Same can be done with laparoscopy. In the past 15 years significant advances in laparoscopic surgical skills and techniques combined with explosive advances in laparoscopic technology have encouraged the application of laparoscopy to the evaluation and treatment of solid organs including the liver. There are many studies about the laparoscopic treatment of liver hydatid cyst published in the literature and the feasibility of this procedure has been demonstrated by them. While the majority of them are case reports or case series, there are some relatively large series comparing open versus laparoscopic surgery published in the last decade, which all are not randomized trial.

Detailed description

This is a multicenter, balanced randomization, double blind, active-controlled, parallel-group, non-inferiority study conducted in Turkey (4 sites). The objective of this trial is to show there is no difference in rate of recurrence 2 years after laparoscopic as compared to open management of cystic echinococcosis of the liver, by at least M (non-inferiority margin). If PLAP/POP: denotes the cure rate in the laparoscopy group (LAP) / open group (OP), then the following two-sided test problem is assessed: H0: POP - PLAP \>= M (Open Surgery is superior to Laparoscopic surgery) H1: POP - PLAP \< M (Laparoscopic surgery is not inferior to open surgery)

Conditions

• Echinococcosis, Hepatic
• Hydatid Cyst

Interventions

Type	Name	Description
PROCEDURE	laparoscopic surgery	In laparoscopy group three trocars is used. The first is 10 mm and inserted within the umbilicus for telescop, the second is 10 mm and inserted just below the xiphoid process, and third is 5 mm and inserted at the right upper quadrant of the abdomen.
PROCEDURE	open surgery	-open surgery group describes the patients treated with traditional open surgery. In open surgery group a right subcostal incision is used.

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-11-01
• Completion: 2012-05-01
• First posted: 2012-07-17
• Last updated: 2012-07-17

Locations

4 sites across 1 country: Turkey (Türkiye)