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

Not Applicable

Completed

• Conditions: Echinococcosis, Hepatic; Hydatid Cyst
• Interventions: Procedure: laparoscopic surgery; Procedure: open surgery

• Registration Number: NCT01643018
• Lead Sponsor: Medical Park Gaziantep Hospital

Brief 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)

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2010-11
• Study Completion: 2012-05
• Study First Submitted: 2012-06-26
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-16
• Last Update Submitted: 2012-07-16
• Study First Posted: 2012-07-17
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• patients eighteen year-old or older
• patients diagnosed as cystic echinococcosis of the liver
• cyst number less then 3
• cyst size greater than 3 cm

Exclusion Criteria

• previous liver surgery
• recurrent disease
• hydatid cyst with multi-organ involvement
• liver hydatid cyst complicated with infection
• contraindication for general anesthesia
• contraindication for laparoscopic surgery
• patient younger than 18
• allergy to albendazole

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic surgery	laparoscopic surgery	-Laparoscopic surgery group describes the patients treated with laparoscopic surgery
Open Surgery	open surgery	-open surgery group describes the patients treated with traditional open surgery

Primary Outcome Measures

Name	Time	Method
cyst recurrence	24 months

Secondary Outcome Measures

Name	Time	Method
quality of life	first week, 1, 6, 12, and 24 month after operation
mortality	24 months
intraoperative complications	24 hours
late complications	24 months
pain score	Post opertaive 6th hour, 1, 2, and 7th days	VAS scoring scale will be use
patient comfort/satisfaction	24 months	will be measured in all follow-up examinations using a scale from 0 (worst) to 10 (excellent).
hospital stay	10 days	postoperative hospital days
duration of the operation	240 minutes	from incision to closure of the skin

Trial Locations

Locations (4)

25 Aralık State Hospital; 🇹🇷 Gaziantep, Turkey

Hatem Hospital; 🇹🇷 Gaziantep, Turkey

Medical Park Gaziantep Hospital; 🇹🇷 Gaziantep, Turkey

Dr.Ersin Aslan State Hospital; 🇹🇷 Gaziantep, Turkey