Clinical Trial: Laparoscopic Versus Open Surgery for the Management of Cystic Echinococcosis of the Liver

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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,

Detailed Summary:

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)


Sponsor: Medical Park Gaziantep Hospital

Current Primary Outcome: cyst recurrence [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Medical Park Gaziantep Hospital

Dates:
Date Received: June 26, 2012
Date Started: November 2006
Date Completion:
Last Updated: July 16, 2012
Last Verified: July 2012