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Gallstones clinical trials

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NCT ID: NCT01104727 Completed - Cholelithiasis Clinical Trials

Multi-Port Versus Single-port Cholecystectomy

MUSIC
Start date: April 2011
Phase: Phase 4
Study type: Interventional

The aim of this study is to compare results of the new surgical strategy to the traditional 4-ports technique for cholecystectomy in a randomized controlled trial (RCT). In particular we are going to investigate the procedures in terms of overall morbidity, while taking into considerations skin-incision's related morbidity, postoperative pain and cosmetic results which are the hypothetical benefits of the new approach. Other parameters are supposed to be unchanged, considering evidences from recent literature. Surgical procedures: 4 ports cholecystectomy (4PC): a 12mmHg pneumoperitoeum is created either by a 10mm umbilical Hasson's port or by a Verress needle followed by a 10mm umbilical port insertion; further one 10mm and two 5mm ports are placed according to the preferred technique. Single Port Access cholecystectomy (SPC): the single-port device is inserted through the umbilicus, by means of an adeguate incision, as the only access to the abdominal cavity. A trans-abdominal suture in right hypochondrium is placed through the gallbladder wall of the fundus to retract it. Primary endpoint: overall morbidity rate (at 60 days from surgery) Secondary endpoints: 1. skin-incision's related morbidity rate (at 60 days from surgery) 2. perioperative pain 3. cosmetic results 4. long-term morbidity (12 months) 5. intraoperative time 6. "conversion SPC to 4PC" rate 7. "conversion to laparotomy" rate 8. hospital stay

NCT ID: NCT01103570 Completed - Clinical trials for Laparoscopic Cholecystectomy

Cholecyst- Versus Cystic Duct Cholangiography During Laparoscopic Cholecystectomy

Start date: March 2009
Phase: Phase 4
Study type: Interventional

Standard cystic duct cholangiography (CDC) during laparoscopic cholecystectomy can be difficult, time consuming and bile duct injury may be caused by attempts to cannulate the cystic duct. Operative cholangiography performed by direct puncture of the gall bladder fundus or Cholecystocholangiography (CCC) is a valid and easier alternative.

NCT ID: NCT01099319 Completed - Cholelithiasis Clinical Trials

Renalof in the Treatment of Elderly Patients With Gallstones

Start date: January 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of Renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evaluation in elderly patients (aged >65 years). The duration of this double-blind placebo controlled phase 3 clinical trial will be 6 months. The estimated number of patients to be recruited and randomized for the study is 40.

NCT ID: NCT01090882 Completed - Gall Stones Clinical Trials

Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

Start date: July 2009
Phase: N/A
Study type: Interventional

Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall bladder decreases pain. In many patients pain has a strong component attributable to diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise that LA injected to the right hemidiaphragm during LC would be more effective than wash. Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline; Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control 'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to eating and mobilising, day case surgery.

NCT ID: NCT01056250 Completed - Cholecystolithiasis Clinical Trials

SILS Cholecystectomy: Cholangiography of the Biliary Tract

Start date: September 2009
Phase: N/A
Study type: Interventional

Single Incision Laparoscopic Surgery (SILS) can be performed for different standard operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to identify and preserve relevant structures. The investigators want to evaluate feasibility of performing cholangiography during SILS cholecystectomy.

NCT ID: NCT01052727 Not yet recruiting - Cholelithiasis Clinical Trials

Day-care Versus Overnight-stay Laparoscopic Cholecystectomy Randomized Controlled Trial.

DOLCE
Start date: n/a
Phase: Phase 4
Study type: Interventional

DOLCE Study: Day-care versus Overnight-stay Laparoscopic Cholecystectomy randomized, controlled trial. The aim of this study was to evaluate the feasibility, safety and patient acceptance of outpatient LC in Italy. In particular this randomized clinical trial will use the SF-36 as powerful instrument to compare quality of life and global health status after LC performed as a day-care procedure or with an overnight stay. Particular attention is taken to answer to the following methodological issues: - concealed randomization, - ITT analysis, - number of eligible, excluded and refusing patients clearly stated.

NCT ID: NCT01047085 Completed - Clinical trials for Gastroesophageal Reflux

Does Cholecystectomy Increase the Esophageal Alkaline Reflux? Evaluation by Impedance-pH Technique

Start date: April 2008
Phase: N/A
Study type: Interventional

Publications with different conclusions are available with regard to the correlations between the cholecystolithiasis, cholecystectomy and gastroesophageal reflux disease (GERD). In this study, the controversial relationship between cholecystolithiasis, cholecystectomy and GERD is discussed through the impedance pH method which started to be used in recent years, a method indicating the gas and liquid (acid and non-acid) gastroesophageal reflux (GER) and esophageal clearance time.

NCT ID: NCT01046552 Completed - Clinical trials for Common Bile Duct Stones.

Comparison Between Pre and Intraoperative ERCP in Treatment of Common Bile Duct Stones

Start date: June 2006
Phase: N/A
Study type: Interventional

ERCP plays an important role in management of common bile duct stones. Herein the investigators compare preoperative against intraoperative ERCP. 210 were included but only 198 patients were randomly divided into two groups; PES/LC (100 patients) and LC/IOES (98 patients). The total hospital stay were significantly shorter in the group of LC/IOES

NCT ID: NCT01039129 Withdrawn - Appendicitis Clinical Trials

Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Start date: December 2009
Phase: N/A
Study type: Interventional

The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.

NCT ID: NCT01010685 Withdrawn - Gallstones Clinical Trials

Safety Study of Keyhole Gallbladder Surgery With Removal of Gallbladder Via the Stomach Rather Than Through the Skin

Start date: December 2009
Phase: N/A
Study type: Interventional

The benefits of laparoscopic ("minimally invasive" or "keyhole") surgery for gallbladder removal (cholecystectomy) over open surgical procedures in terms of significant reductions in pain, scarring and recovery time are well accepted. In a conventional laparoscopic cholecystectomy however, the excised gallbladder still has to be extracted through the abdominal wall skin via a laparoscopic port site using an incision of 10mm or greater. Despite being much smaller than that required for open surgery, this incision is painful, leaves a scar and can result in a port site hernia to follow requiring further surgery to repair it. Recent attempts to further reduce the invasiveness of the surgical procedure have suggested performing the operation via an endoscope passed through the mouth and through an incision in the stomach wall - so called Natural Orifice Translumenal Endoscopic Surgery (NOTES). Unlike a skin incision, an incision in the wall of the stomach (gastrotomy) should give no pain, visible scar or herniation risk yet still allow access to the peritoneal cavity for surgical procedures such as cholecystectomy. Against this, it has the potential risks of contamination and leakage of gastric contents into the peritoneal cavity. Whilst the limitations of present technology make it very difficult to perform an entire cholecystectomy through the stomach wall in patients, endoscopic methods for closing a gastrotomy are available that are approved for use in patients (CE marked) and it is hypothesised that removing the excised gallbladder through the stomach in this way would avoid the problems of extracting it through the abdominal wall described above. Data are required to determine whether the extraction of the gallbladder via a gastrotomy rather than through the skin is safe, producing smaller scars and a better cosmetic result. A secondary endpoint would be to assess possible reductions in pain and recovery from this less invasive approach.