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Gallstones clinical trials

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NCT ID: NCT01625026 Completed - Obesity Clinical Trials

Obeticholic Acid in Bariatric and Gallstone Disease

OCABSGS
Start date: September 2013
Phase: Phase 2
Study type: Interventional

By binding to the nuclear receptor FXR, bile acids not only regulate their own turn-over but presumably also pivotal steps in cholesterol, triglyceride and glucose metabolism as shown in laboratory animals. Obeticholic acid (OCA) is a semisynthetic bile acid with very high affinity to FXR. In a pharmacodynamic study the effects of OCA on bile acid, lipid and glucose turn-over are studied in 20 morbidly obese and 20 gallstones patents, respectively, that are administered OCA at 25 mg/day in three weeks before bariatric (BS) or gallstone (GS) surgery where in addition to blood samples also biopsies are taken from the liver and in the case of BS, omental and subcutaneous adipose tissue and in case of GS, gallbladder bile.

NCT ID: NCT01583348 Completed - Gallstone Disease Clinical Trials

Technical Feasibility of Routine Intraoperative Cholangiography During Elective Rigid-hybrid Transvaginal Natural Orifice Transluminal Endoscopic Cholecystectomy

Start date: April 2012
Phase: N/A
Study type: Observational

While gold standard in the treatment of symptomatic gall stones is laparoscopic cholecystectomy with instruments introduced through multiple abdominal wall incisions, transvaginal access to the peritoneal cavity offers an alternative avoiding injury of the abdominal wall. Transvaginal hybrid-NOTES cholecystectomy has been demonstrated effective and safe. However it has not been demonstrated up-to-date if intraoperative cholangiography is feasible during such procedure. This observational case series describes success and technical feasibility of intraoperative cholangiography during transvaginal cholecystectomy. The investigators hypothesis is that cholangiography is feasible equal to conventional laparoscopic cholecystectomy.

NCT ID: NCT01571271 Completed - Gall Stones Clinical Trials

Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones

EHLvlaser
Start date: January 2010
Phase: N/A
Study type: Interventional

Bile duct stones that can't be removed by conventional means can often be removed after fragmentation by shock waves (lithotripsy). The shock waves that are used for fragmentation of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser (laser lithotripsy). Although both techniques have been used for many years, there are no studies comparing the efficacy of the two. The purpose of this study is to find out which technique is more effective.

NCT ID: NCT01558414 Completed - Surgery Clinical Trials

Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

Start date: April 2011
Phase: Phase 3
Study type: Interventional

Prospective randomized pilot clinical trial, with 3 arms and one year follow up. The study will include 60 patients, with a 1:1:1 ratio, 20 patients per group. In 40 patients a transumbilical single site incision will be performed with two different manners: single-port device SILS TM (Single Incision Laparoscopic Surgery), and flexible endoscope and accessory trocars in a single incision (FSIS-Flexible Single Incision Surgery). The third group is the control one, a conventional laparoscopic approach. The trial is designed as a pilot study to assess, as main objective, if these two endoscopic approaches have the same security and effectiveness in cholecystectomy. Hypothesis: Transumbilical approaches with single port and single incision with the flexible endoscope have the same efficacy and safety performing the endoscopic cholecystectomy. Objectives: Main objective: Assess whether both approaches are equally safe in its application to endoscopic cholecystectomy. Secondary objectives: Investigate the differences in the rate of conversion to open surgery between different surgical approaches. Investigate the differences in the rate of wound infection between the different surgical approaches. Investigate the differences in the rate of postoperative incisional hernias between different surgical approaches. Investigate whether there are differences in the rate of overall complications, all-cause mortality and the cost between different surgical approaches.

NCT ID: NCT01553331 Completed - Cholecystolithiasis Clinical Trials

Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook

Start date: March 2012
Phase: N/A
Study type: Interventional

Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. Ultrasonic dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with ultrasonic dissection technique a better same day discharge and a shorter operative time can be achieved.

NCT ID: NCT01492790 Completed - Cholecystitis Clinical Trials

Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy

CCK first
Start date: June 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate if cholecystectomy first (studied group) versus sequential common bile duct imaging/cholecystectomy (control group) result in a decrease of hospital stay, morbidity/mortality and costs in the management of patients with a suspicion of gallstone migration.

NCT ID: NCT01489436 Completed - CHOLELITHIASIS Clinical Trials

A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal

CENoMIP
Start date: July 2011
Phase: N/A
Study type: Interventional

New minimally invasive surgical treatments are often outpatient procedures with low complication rates, promising fast recovery. The traditional physician-reported outcomes such as complication rates, blood loss, and hospital stay are not useful to guide treatment recommendations for one or the other minimally invasive procedure. This study aims to apply patient-reported outcomes developed within the NIH framework for cancer research and chronic disease treatment to the comparative effectiveness research in minimally invasive procedures for benign disease.

NCT ID: NCT01424215 Completed - Cholecystitis Clinical Trials

The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy

Start date: January 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether a fluorescent die and a special infrared camera can assist with the identification of the important structures during laparoscopic cholecystectomy. This finding may assist surgeons to perform laparoscopic cholecystectomy in less time and in a safer fashion than standard laparoscopic cholecystectomy.

NCT ID: NCT01410734 Completed - Gallstones Clinical Trials

Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)

Start date: July 2011
Phase: N/A
Study type: Interventional

The investigators hypothesize that the da Vinci Fluorescence Imaging Vision System provides real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as identifying biliary vessels; either cystic duct, common hepatic duct (CHD) or common bile duct (CBD). Irradiation given to the patient during a classic cholangiography can be reduced.

NCT ID: NCT01397565 Completed - Cholelithiasis Clinical Trials

Minilaparoscopic Versus Conventional Laparoscopic Cholecystectomy

Start date: February 2012
Phase: Phase 4
Study type: Interventional

Laparoscopic cholecystectomy is one of the most commonly performed operations in general surgery and is considered the standard of care for cholecystectomy for benign biliary disease. The laparoscopic approach to cholecystectomy, when compared to open surgery, is associated with less postoperative pain, quicker recovery time and an improved cosmetic result. Most commonly, laparoscopic cholecystectomy is performed using a 10-12mm port in the umbilicus with 3 additional ports consisting of either three 5mm ports, or a combination of two 5mm ports and one 10mm port. A new technique called minilaparoscopic (also referred to as needlescopic) surgery has recently emerged. Minilaparoscopic surgery replaces 5mm trocars with smaller 3mm trocars. Surgery using these smaller trocars is hypothesized to further reduce postoperative pain and recovery time as well as improve cosmetic results following laparoscopic surgery. Our goal is to compare these outcomes in a randomized trial comparing conventional to minilaparoscopic cholecystectomy.