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Cholelithiasis clinical trials

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NCT ID: NCT01740973 Completed - Incisional Hernia Clinical Trials

Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy

UMBI-SILS
Start date: April 2014
Phase: N/A
Study type: Observational

Background Laparoscopic cholecystectomy is a very common procedure. Postoperative pain, especially around the umbilical port is dominating the first postoperative week. Single Incision Laparoscopic cholecystectomy (SILC) has been proposed to diminish postoperative incisional pain and improve cosmetic results, but results are not convincing and the risk of formation of an umbilical trocar-site hernia is not properly investigated. This study aimed to investigate the risk of umbilical trocar-site hernia formation after SILC vs. conventional 4-port laparoscopic cholesystectomy. Methods This is a cohort registry study with prospective questionnaire and clinical follow-up on 239 patients having a SILC from 1/1 2009 to 1/6 2011 vs. 478 mathed patients having a conventional laparoscopic cholecystectomy (consecutively from one month before and after SILC. They are matched for age, gender, date of operation, and surgeons skills (database from intraoperatively registered data). Primary endpoint is umbilical trocar-site hernia formation (operation for a umbilical hernia or clinical hernia). The H0 hypothesis is that there is not difference between SILC and conventional. Exclusion criteria are: death, operation for acute cholecystitis. The included patients will be sent a questionnaire asking for operation for a hernia in the area, suspicion of a hernia, and perioperative data that we do not have in the database. Futhermore those patients who suspect a hernia will be invited to aclinical exam by a medic to state the diagnosis. Furthermore we patients are asked to report if they have chronic pain and/or discomfort.

NCT ID: NCT01715220 Recruiting - Clinical trials for BILIARY TRACT DISEASES

Treatment of Suspected Cholelithiasis With Nitroglycerin

Start date: October 2014
Phase: Phase 2
Study type: Interventional

ABSTRACT: Sublingual nitroglycerin has been advocated for the treatment of acute pain from suspected symptomatic cholelithiasis. There is, however, no clinical studies that validate its use. This study is designed to evaluate the efficacy of nitroglycerine in relieving acute pain of suspected biliary tract origin. Nitroglycerin is a potent smooth muscle relaxant used for biliary tract dilation during ERCP, (Chelly, J) and has been recommended for treatment of biliary colic based on anecdotal experience and small case reports. Nitroglycerin effect is a result of the nitric oxide component of the medication which acts as a smooth muscle relaxant in vascular, bronchial, esophageal and biliary smooth muscles. [McGowan(1936), Chelly (1979),Toyoyama (2001)] The typical dose of nitroglycerin is 0.4 mg given sublingually in pill form or, more recently, in a metered spray form. In a case series reported by Hassel (1993), positive response times ranged from 20 to 60 seconds with duration of action of two to twelve hours. Sublingual nitroglycerin is most commonly used for treatment of chest pain related to insufficient cardiac perfusion. It has also been noted to relieve the pain of esophageal spasms. Nitroglycerin has an excellent safety profile if used in patients with adequate pretreatment blood pressures. [Newberry (2005), Nitroglycerine (2011), Nitro (2011), Wolters (2009)] This study proposes to compare sublingual 0.4 mg doses of nitroglycerin to placebo for the initial treatment of acute pain from suspected symptomatic cholelithiasis

NCT ID: NCT01708109 Terminated - Cholelithiasis Clinical Trials

Optimal Handling of Common Bile Duct Calculus, a Prospective Study

Start date: November 27, 2011
Phase: N/A
Study type: Interventional

The purpose is to study natural process of gallstones in common bile duct, stones less than or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The second outcome is to study side-effects of gallstones removed with surgery.

NCT ID: NCT01687959 Active, not recruiting - Clinical trials for Cholelithiasis Associated With Common Bile Duct Stones

Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis

Start date: September 2012
Phase: Phase 0
Study type: Interventional

Timing of laparoscopic cholecystectomy following after endoscopic retrograde cholangiography for acute biliary pancreatitis is a controversial issue. There are still many confounding findings offering either early laparoscopic cholecystectomy within 72 hours following endoscopic sphincterotomy or delayed surgery after 6 weeks. Peritoneal plasmin system is known to be an important factor in peritoneal healing and adhesion formation. Measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are thought to be helpful to show peritoneal adhesions after endoscopic sphincterotomy.

NCT ID: NCT01685775 Completed - Clinical trials for Laparoscopic Cholecystectomy

Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy

NATCH
Start date: February 2010
Phase: N/A
Study type: Interventional

Laparoscopic surgery has become the golden standard for the removal of the gallbladder. Recently, developments have been made so that operations can be performed through a natural orifice instead of the abdominal wall, thus minimizing the trauma of a procedure. This study compares the transvaginal/transumbilical cholecystectomy with the laparoscopic operation using 2-3mm instruments in female patients. It also examines the benefits and disadvantages related to postoperative pain, cosmetic aspects, and potential physiological alterations to the transvaginal approach that affect sexual intercourse.

NCT ID: NCT01678391 Completed - Clinical trials for Common Bile Duct Gall Stones

Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

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

To assess the feasibility and success of endoscopic ultrasound (EUS) directed biliary stone removal without use of fluoroscopy. Success for this study will be defined as the successful removal of all stones from the bile duct without the use of fluoroscopy. Fluoroscopy will only be used at the end of a presumed successful procedure to confirm that all stones are removed.

NCT ID: NCT01667848 Completed - Cholecystolithiasis Clinical Trials

Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy

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

The purpose of this study is to determine the effect of warmed, humidified carbon dioxide Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.

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: NCT01615549 Recruiting - Cholecystitis Clinical Trials

Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator

Start date: April 2004
Phase: N/A
Study type: Interventional

Virtual reality devices are widely accepted tools to familiarize surgical novices with the principles of laparoscopy. Free Virtual reality training will be tested against basic training and efficacy assessed in a randomized controlled trial of surgical novices.

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.