Laparoscopic Versus Open Surgery for the Management of Cystic Echinococcosis of the Liver
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|ClinicalTrials.gov Identifier: NCT01643018|
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : July 17, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Echinococcosis, Hepatic Hydatid Cyst||Procedure: laparoscopic surgery Procedure: open surgery||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Laparoscopic Versus Open Conservative Surgery for the Management of Cystic Echinococcosis of the Liver: Prospective, Randomized, and Controlled Clinical Trial of Efficacy and Safety|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||May 2012|
Experimental: laparoscopic surgery
-Laparoscopic surgery group describes the patients treated with laparoscopic surgery
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.
Other Name: Laparoscopy
Active Comparator: Open Surgery
-open surgery group describes the patients treated with traditional open surgery
Procedure: open surgery
-open surgery group describes the patients treated with traditional open surgery. In open surgery group a right subcostal incision is used.
- cyst recurrence [ Time Frame: 24 months ]
- mortality [ Time Frame: 24 months ]
- intraoperative complications [ Time Frame: 24 hours ]
- late complications [ Time Frame: 24 months ]
- pain score [ Time Frame: Post opertaive 6th hour, 1, 2, and 7th days ]VAS scoring scale will be use
- patient comfort/satisfaction [ Time Frame: 24 months ]will be measured in all follow-up examinations using a scale from 0 (worst) to 10 (excellent).
- hospital stay [ Time Frame: 10 days ]postoperative hospital days
- duration of the operation [ Time Frame: 240 minutes ]from incision to closure of the skin
- quality of life [ Time Frame: first week, 1, 6, 12, and 24 month after operation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643018
|Gaziantep, Turkey, 27090|
|Medical Park Gaziantep Hospital|
|Gaziantep, Turkey, 27090|
|25 Aralık State Hospital|
|Gaziantep, Turkey, 27100|
|Dr.Ersin Aslan State Hospital|
|Gaziantep, Turkey, 27100|
|Principal Investigator:||MEHMET KAPLAN, MD||Medical Park Gaziantep Hospital, Gaziantep, Turkey|