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Gallstones clinical trials

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NCT ID: NCT00863642 Completed - Clinical trials for Gallstone Pancreatitis

Early Versus Delayed Surgery for Gallstone Pancreatitis

Start date: November 2007
Phase: N/A
Study type: Interventional

While there exists consensus among surgeons that patients with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, the precise timing of laparoscopic cholecystectomy for mild to moderate disease remains controversial. We hypothesize that laparoscopic cholecystectomy performed within 48 hours of admission, regardless of resolution of abdominal pain or abnormal laboratory values, will result in a shorter hospital stay.

NCT ID: NCT00836316 Completed - Pain Clinical Trials

Levobupivacaine During Cholecystectomy

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

The purpose of this study is to determine the effects of intraperitoneal administration of levobupivacaine on pain after laparoscopic cholecystectomy.

NCT ID: NCT00835250 Completed - Cholelithiasis Clinical Trials

Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery

Start date: February 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).

NCT ID: NCT00815438 Withdrawn - Cholecystitis Clinical Trials

Transvaginal Cholecystectomy Using Endoscopic Assistance

Start date: January 2009
Phase: Phase 1
Study type: Interventional

Surgical removal of the gallbladder is needed in 1 million people per year in the USA. The procedure is done by placing four tubes (cannula) from 5 to 10 mm through the abdominal wall. Air is placed in the abdominal cavity and a lighted scope is placed through one cannula. The space in the abdominal cavity can then be seen on a video screen. Thin retractors and dissecting instruments are placed through the other cannula and the gallbladder is removed using the video screen for vision. The gallbladder duct and the artery are usually occluded with clips or stitches. In this study we propose to do the procedure though a single 5 mm incision placed at the umbilicus and a second access through the vagina using a flexible endoscope. The gallbladder will be retracted using strings (sutures) attached to the gallbladder. The dissection will be done using laparoscopic instruments (scissors, knives, dissectors) placed through the laparoscopic port. A flexible grasper may be used in the endoscope to help with retraction. An endoscopic snare or grasper will be used to grasp the gallbladder and remove it from the abdomen through the vagina. This study evaluates the ability to do laparoscopic cholecystectomy with one skin incision and one vaginal incision. This will provide the basis for future studies evaluating decreased pain and costs with transvaginal assisted cholecystectomy.

NCT ID: NCT00807729 Completed - Clinical trials for Common Bile Duct Stones

Randomized Trial of ERCP Then Laparoscopic Cholecystectomy vs. Laparoscopic Cholecystectomy Plus Laparoscopic Common Bile Duct Exploration in Patients With Likely Choledocholithiasis

ERCP/CBDE
Start date: January 1997
Phase: N/A
Study type: Interventional

Objective: We compared outcome parameters for good-risk patients with classic signs, symptoms, laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to either LC + LCBDE or ERCP/S + LC. Design: Our study was a prospective trial conducted following written informed consent with randomization by the serially-numbered opaque envelope technique. Setting: Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco. Patients: We randomized 122 patients (American Society of Anesthesiologists Grade I or II) meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol violators having signed out of the hospital against medical advice before one of both procedures were completed. Interventions: Treatment was pre-operative endoscopic retrograde cholangiopancreatography sphincterotomy (ERCP/S) followed by laparoscopic cholecystectomy (LC), or laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC + LCBDE). Main Outcome Measures: The primary outcome measure was efficacy of stone clearance from the common bile duct. Secondary endpoints were length of hospital stay, cost of index hospitalization, professional fees, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores.

NCT ID: NCT00792389 Not yet recruiting - Gallstone Clinical Trials

Study of the Use of Humidified Warmed Gas and the Effect on Post-Operative Pain in Laparoscopic Cholecystectomies

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

Double blind RCT comparing elective laparoscopic cholecystectomy using warmed, humidified gas (new) against laparoscopic cholecystectomy with cool, dry gas (usual). Sample size of 200 patients. Outcome measures are postoperative opiate analgesia use, and post operative numerical pain scores.

NCT ID: NCT00732550 Completed - Cholelithiasis Clinical Trials

Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

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

The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.

NCT ID: NCT00711581 Completed - Cholelithiasis Clinical Trials

Evaluation of Laparoscopic Internal Retractor Device

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

The purpose of this study is to determine the safety and efficacy of the Endograb system which is an internal laparoscopic retractor device. This retractor device is inserted into the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal incisions in a laparoscopic operation.

NCT ID: NCT00710502 Completed - Cholelithiasis Clinical Trials

Transvaginal NOTES Cholecystectomy: Phase I/II Mexico Clinical Trial

Start date: January 2009
Phase: Phase 1/Phase 2
Study type: Interventional

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 disease has been estimated to cost U.S. healthcare $5 billion/year. Laparoscopic cholecystectomy was introduced in the early 1990s and has become the standard surgical approach for the treatment of gallbladder disease. More than 500,000 cholecystectomy procedures are performed in the US every year. Laparoscopic cholecystectomy is now performed as an outpatient basis and is related to a very low complication rate. Laparoscopic cholecystectomy requires the use of multiple trocar incisions. Natural Orifice Translumenal Endoscopic Surgery(NOTES) is a new type of surgical procedure currently being studied around the world. The idea of NOTES was developed several years ago in response to the concepts that patients would 1. realize the benefits of less invasive surgery by reducing the recovery time, 2. experience less physical discomfort associated with traditional procedures 3. have virtually no visible scarring following this type of surgery. All of these advantages have spurred research and investigation forward, encouraging physicians and researchers to develop new equipment and techniques to use during NOTES procedures. Although the Natural Orifice Translumenal Endoscopic Surgery approach may hold tremendous potential, there are many issues that need to be addressed before this technique is introduced into clinical care. The purpose of this study is to determine the safety, feasibility and short-term clinical outcomes (Phase I trial) of transvaginal NOTES cholecystectomy in female patients with symptomatic cholelithiasis and compare it to Laparoscopic Cholecystectomy (Phase II). Hypothesis 1: Transvaginal NOTES cholecystectomy is safe and feasible in female patients with symptomatic cholelithiasis. Hypothesis 2: The short term outcomes of Transvaginal NOTES cholecystectomy are comparable to Laparoscopic Cholecystectomy in female patients with symptomatic cholelithiasis. Aim 1: Determine the safety of Transvaginal NOTES cholecystectomy. Aim 2: Determine the feasibility of Transvaginal NOTES cholecystectomy. Aim 3: Determine the short-term outcomes of Transvaginal NOTES cholecystectomy. Aim 4: Compare the short-term outcomes of Transvaginal NOTES cholecystectomy to Laparoscopic cholecystectomy.

NCT ID: NCT00678873 Completed - Cholelithiasis Clinical Trials

Single Incision Laparoscopic Cholecystectomy

SILC
Start date: March 2008
Phase: Phase 1
Study type: Interventional

The investigators aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy. The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.