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
1 other identifier
interventional
350
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2006
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 26, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedJuly 17, 2012
July 1, 2012
4 years
June 26, 2012
July 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cyst recurrence
24 months
Secondary Outcomes (8)
mortality
24 months
intraoperative complications
24 hours
late complications
24 months
pain score
Post opertaive 6th hour, 1, 2, and 7th days
patient comfort/satisfaction
24 months
- +3 more secondary outcomes
Study Arms (2)
laparoscopic surgery
EXPERIMENTAL-Laparoscopic surgery group describes the patients treated with laparoscopic surgery
Open Surgery
ACTIVE COMPARATOR-open surgery group describes the patients treated with traditional open surgery
Interventions
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.
-open surgery group describes the patients treated with traditional open surgery. In open surgery group a right subcostal incision is used.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hatem Hospital
Gaziantep, 27090, Turkey (Türkiye)
Medical Park Gaziantep Hospital
Gaziantep, 27090, Turkey (Türkiye)
25 Aralık State Hospital
Gaziantep, 27100, Turkey (Türkiye)
Dr.Ersin Aslan State Hospital
Gaziantep, 27100, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MEHMET KAPLAN, MD
Medical Park Gaziantep Hospital, Gaziantep, Turkey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MKaplan
Study Record Dates
First Submitted
June 26, 2012
First Posted
July 17, 2012
Study Start
November 1, 2006
Primary Completion
November 1, 2010
Study Completion
May 1, 2012
Last Updated
July 17, 2012
Record last verified: 2012-07