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Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.
This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.
This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.
After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
SILS, Standard Laparoscopic Cholecystectomy
Children's Mercy Hospital
Children's Mercy Hospital Kansas City
Published on BioPortfolio: 2014-08-27T03:19:11-0400
The objectives of this trial are: 1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 2. monitor and compare the outcomes of SI...
Single Incision Laparoscopic Surgery (SILS) can be performed for different standard operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy sometimes a cho...
The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.
Cholecystectomy is one of the most common general surgery procedures performed in the US today and is among top 10 procedures performed in U.S. hospitals annually, and biliary tract diseas...
To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans a...
Laparoscopic subtotal cholecystectomy (LSC) is a widely used technique for managing cholelithiasis with severe cholecystitis. The increasing popularity its utilization is due to the good safety profil...
To improve surgical treatment of patients with cholelithiasis and obesity by using of different technologies of laparoscopic cholecystectomy.
Laparoscopic cholecystectomy is considered the gold standard for the management of acute cholecystitis but controversy surrounds the timings of the surgery. Studies are available favouring both early ...
Management of appendicitis has evolved dramatically in the last 120 years, from McBurney's large incision to minimally invasive laparoscopic appendectomy to hardly noticeable incisions with SILS. As...
Bile spillage (BS) occurs frequently during laparoscopic cholecystectomy, yet its impact on postoperative outcomes remains unknown. We hypothesized that BS increases the risk of surgical site infectio...
Excision of the gallbladder through an abdominal incision using a laparoscope.
Excision, in part or whole, of an intervertebral disk. The most common indication is disk displacement or herniation. In addition to standard surgical removal, it can be performed by percutaneous diskectomy (DISKECTOMY, PERCUTANEOUS) or by laparoscopic diskectomy, the former being the more common.
Surgical removal of the GALLBLADDER.
Complication of CHOLELITHIASIS characterized by OBSTRUCTIVE JAUNDICE; abdominal pain, and fever.
Hemorrhage in or through the BILIARY TRACT due to trauma, inflammation, CHOLELITHIASIS, vascular disease, or neoplasms.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...