Biliary Stones Clinical Trial
Official title:
Comparison of Laparoscopic Versus Open Operation for Hepatolithiasis
The purpose of this research is to investigate the key technology and the related issues of minimal invasive treatment for hepatolithiasis and to build new methods of minimal invasive operation for hepatolithiasis. The validity, feasibility and limitations of the laparoscopic operation were assessed objectively through our clinical prospective study. The technique points, indications and contraindications were summarized to evaluate the status and role of minimal invasive laparoscopic operation in the treatment of hepatolithiasis.
Background: China is the high incidence area of hepatolithiasis. The development of minimal
invasive techniques opened up a new situation for the treatment of hepatolithiasis, but it
has not been widely applied.
Intervention: Comparison of minimal invasive versus open operation for hepatolithiasis: a
prospective randomized study. One hundred patients with early regional hepatolithiasis were
selected and divided into laparoscopic operation group and open operation group randomly,
each group contains 50 cases. Laparoscopic anatomical hepatectomy or open regular
hepatectomy were performed respectively, combined with cholecystectomy and bile duct
exploration when necessary. The intraoperative ultrasound and choledochoscope were used
selectively.
Results:
1. Clinical data: previous operation history, operation time, intraoperative blood loss,
volume of blood transfusion, complications and mortality, postoperative liver function,
residual stones, recurrence rate, long-term curative effect and survival time were
collected and analysed.
2. Statistical method: univariate/multivariate analysis, logistic regression analysis,
mixed linear regression, Cox survival analysis were used.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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