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Gallstones clinical trials

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NCT ID: NCT01278472 Recruiting - Clinical trials for Symptomatic Gallstone Disease

Cosmesis and Body Image After Single Port or 4-Port Laparoscopic Cholecystectomy

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

Laparoscopic Cholecystectomy (LC) is the treatment of choice for symptomatic gallstone disease. Single-port access cholecystectomy (SL) has been recently introduced using only one, trans-umbilical placed port. The method has been denominated as ''scarless.'' However, it is unknown whether SL significantly improves body and cosmesis images as well as the quality of life (QoL), reported directly by the patients. Furthermore SL promises to reduce postoperative pain and to be cost-effective due a faster postoperative recovery. The aim of this Double Blind Randomized Controlled Trial (RCT) is to demonstrate whether SL is superior to LC in improving patients', body and cosmesis images as well as QoL and to analyse cost-efficiency. Based on the sample size calculations, a total of 110 patients will be randomised to either LC or SL. The primary endpoint will be the cosmetic score. Costs, pain, time to convalescence, quality of life and complications and will also be compared as secondary endpoints. This study will provide evidence-based patient-oriented information regarding the SL procedure and its further use.

NCT ID: NCT01232959 Withdrawn - Gallstones Clinical Trials

Feasibility of Transvaginal Cholecystectomy

TVC
Start date: October 2010
Phase: N/A
Study type: Interventional

Today there are three different ways to remove a gallbladder with gallstones. Surgeons can remove the gallbladder through small incisions in the abdomen. This is called laparoscopic cholecystectomy. It is the current standard. It has replaced traditional open gallbladder surgery. Open gallbladder surgery is done with a large incision. A new way of removing the gallbladder in women is through the vagina. This is called transvaginal cholecystectomy. This study is being done to see if removing the gallbladder through the vagina will work for patients at Mayo Clinic Rochester. This is the first step of this research to test the procedure. In the future, other studies will examine the potential for less scarring and reduced pain. In this study the investigators will still make small incisions in the abdomen, they will be smaller than the standard procedure but you will still have some scars on your abdomen. Some very early research reports say that some patients may have less pain with the transvaginal approach; however, the investigators do not know if the transvaginal route will have any effect on your overall health and quality of life. This study will evaluate: - Effectiveness of the surgery: ability to remove the gallbladder safely - Effect of the operation on your body: change in pulse and blood pressure during the surgery, level of inflammation markers in your blood before and after the surgery - Recovery from surgery in the hospital: how much pain you have, how much pain medication you need, how long you need to stay in the hospital, or nature of any surgical complications (problems) - Overall recovery from surgery: general quality of life, abdominal symptoms What is the new type of surgery? The new type of surgery is called transvaginal cholecystectomy: A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps the surgeons to remove your gallbladder through the vagina. The procedure to separate your gallbladder from your body will be assisted by instruments placed through your abdomen and instruments placed in your vagina. The surgeon will remove the gallbladder by passing it though your vagina.

NCT ID: NCT01211743 Completed - Laparoscopy Clinical Trials

Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy

Start date: June 2010
Phase: Phase 4
Study type: Interventional

Study of Oxidative Stress Markers in order to assess whether there are differences between standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated cholelithiasis

NCT ID: NCT01199406 Completed - Postoperative Pain Clinical Trials

Pain Reduction After Cholecystectomy

INTENSE
Start date: July 2009
Phase: Phase 4
Study type: Interventional

To determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up to 24 hours after surgery.

NCT ID: NCT01195285 Terminated - Cholecystitis Clinical Trials

Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

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

This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.

NCT ID: NCT01190280 Completed - Gallstones Clinical Trials

Indications for Gallbladder Surgery in Gallstone Disease

Start date: October 1991
Phase: Phase 3
Study type: Observational

The aim of the study is to identify patients with gallstone disease that should be operated and those that may potentially be observed. This selection was based on symptoms and clinical presentation. The consequences that may arise for the patient if observation is chosen compared with outcome after cholecystectomy has been markers of outcome.

NCT ID: NCT01146184 Withdrawn - Pain Clinical Trials

Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)

IRB#08-181
Start date: November 2009
Phase: N/A
Study type: Interventional

The aim of this study is to improve the technique of laparoscopic cholecystectomy by using a flexible endoscope passed through a single umbilical skin incision, as previously reported, now with the use of Manually Articulating Devices (Ethicon Endo-Surgery, Inc.) through the endoscope.

NCT ID: NCT01139385 Completed - Cholelithiasis Clinical Trials

Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery

CLCHS
Start date: January 2008
Phase: N/A
Study type: Observational

The aim of this study was to compare between the safety and efficacy of the harmonic shears and the commonly used clip technique in achieving safe closure and division of the cystic duct in the laparoscopic cholecystectomy in day surgery setting

NCT ID: NCT01117415 Completed - Cholelithiasis Clinical Trials

Cost Effectiveness Analysis of Cholecystectomy, Projected Long Term Outcomes and Complications Evaluation

NOTES
Start date: April 2007
Phase: N/A
Study type: Observational

Participation in this research study does not involve any procedures. Health preference will be ascertained through standard techniques including time-tradeoff, standard gamble, and rating scale to assess risks regarding potential complications specific to NOTES (Natural Orifice Translumenal Endoscopic Surgery)gallbladder removal.

NCT ID: NCT01116492 Completed - Clinical trials for Inflammatory Response

Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis

Lap vs SILS
Start date: January 2010
Phase: N/A
Study type: Interventional

This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy.