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Cholecystitis clinical trials

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NCT ID: NCT01015417 Completed - Clinical trials for Preoperative Amoxicillin Clavulanic Acid for at Most 5 Days

Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis

ABCAL
Start date: May 2010
Phase: Phase 3
Study type: Interventional

Assess whether postoperative antibiotics after cholecystectomy for acute lithiasic cholecystitis little or moderately severe, is effective and therefore justified. The main objective is to compare the occurrence of postoperative infectious complications including surgical site infections (SSI) and remote infections after early cholecystectomy (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC) little or moderately serious (without organ dysfunction) with and without postoperative antibiotics. The secondary objectives are: - Rates of infectious complications according to duration of preoperative antibiotic - Influence of surgical drainage after surgery for occurrence of postoperative infectious complications - Analysis of the nature of infectious complications (surgical site infections, remote surgical site infections) - Comparison of germs found in the bile during the postoperative infectious complications - Duration of hospitalization - Readmission rate for surgical site infections - Rate of reoperation for surgical site infection - Overall mortality rate at 30 days - Mortality rates specific to 30 days

NCT ID: NCT00940264 Completed - Cholecystitis Clinical Trials

Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.

Start date: September 2008
Phase: N/A
Study type: Observational

Transvaginal hybrid procedures especially the transvaginal hybrid cholecystectomy are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety in a selected patient collective. The aim of this prospective data collection is to evaluate the feasibility in the clinical routine in a non select patient collective. Therefore all patients giving the informed consent to the transvaginal hybrid cholecystectomy will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.

NCT ID: NCT00904865 Recruiting - Cholecystitis Clinical Trials

Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

Start date: February 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Background: Single port access surgery is a rapidly progressing surgical approach which allows performance of standard laparoscopic surgery through a single transparietal port instead of multiple port accesses. Objective: Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple ports laparoscopic cholecystectomy. Hypothesis: SPA cholecystectomy is associated with decreased parietal and body image trauma compare to multiple ports laparoscopic cholecystectomy. SPA cholecystectomy should be associated with better cosmetic results, may improve postoperative recovery due to lower parietal pain. SPA cholecystectomy may also be associated with decreased rate of parietal complications as lower numbers of transparietal port are placed. Methods: All patients offered cholecystectomy, either SPA or multiport cholecystectomy, included in the study will have recognized biliary pathology for which formal indication cholecystectomy are recognized internationally. Surgical technique, either for SPA cholecystectomy or for multiple ports cholecystectomy, will be the same except, that one surgical technique is achieved through a single transparietal port and the other through multiple ports. Randomization will be performed before surgeries after patients have given their informed consent to the study. No specific test or cost will be necessitated by the study. Patients will be informed orally and will receive a short study summary, allowing them to give an informed consent. Endpoints: - Morbidity - Body image and Cosmetic results - Post-operative pain (opioid sparing effect) - Operative time - Hospital stay

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: NCT00746850 Completed - Cholecystitis Clinical Trials

Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis

HAC
Start date: September 2008
Phase: N/A
Study type: Interventional

In the developmental stage of laparoscopic cholecystectomy it was considered 'unsafe' or 'technically difficult' to perform laparoscopic cholecystectomy for acute cholecystitis. With increasing experience in laparoscopic surgery, a number of centers have reported on the use of laparoscopic cholecystectomy for acute cholecystitis, suggesting that it is technically feasible but at the expense of a high conversion rate, which can be up to 35 per cent and common bile duct lesions. The HARMONIC SCALPEL® (H) is the leading ultrasonic cutting and coagulating surgical device, offering surgeons important benefits including: minimal lateral thermal tissue damage, minimal charring and desiccation. H technology reduces the need for ligatures with simultaneous cutting and coagulation: moreover there is not electricity to or through the patient H has a greater precision near vital structures and it produces minimal smoke with improved visibility in the surgical field. In retrospective series LC performed with H was demonstrated feasible and effective with minimal operating time and blood loss: it was reported also a low conversion rate (3.9%). However there are not prospective randomized controlled trials showing the advantages of H compared to MD (the commonly used electrical scalpel) in LC. Aim of this RCT is to demonstrate that H can reduce conversion rate compared to MD in LC for AC.

NCT ID: NCT00634140 Withdrawn - Clinical trials for Chronic Acalculous Cholecystitis

The Influence of Ezetimibe on Gallbladder Function

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

Ezetimibe is a drug which inhibits the absorption of both dietary and biliary cholesterol in the small intestine. Ezetimibe has been approved for use in humans to lower serum cholesterol. The primary aim of this study is to determine if ezetimibe normalizes resting and residual volume in patients with chronic acalculous cholecystitis.

NCT ID: NCT00591968 Completed - Clinical trials for Abdominal Aortic Aneurysm

Telesonography Adaptation and Use to Improve the Standard of Patient Care Within a Dominican Community

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

The role of teleradiology has far reaching implications for the health of remote and underserved populations. The ability to coordinate radiographic evaluation and diagnosis from a distance has the potential to raise the standard of patient care throughout the world. Perhaps the safest and most cost effective mode of teleradiology today is telesonography. The current project attempts to determine the extent that telesonography improves the standard of care within a rural government-run primary clinic within the Dominican Republic. The work reported herein is intended to compare the use of telesonography to the current standard of sonographic examination (referral to government hospital 60km from target clinic). The study was conducted by randomly assigning 100 patients with clinical indications for sonographic examination into experimental and control groups. Following a 60-day implementation period, the following research questions will be addressed: 1) To what extent does the use of asynchronous telesonography increase the percentage of definitive diagnoses based on the total number of scans (definitive diagnoses / total number of scans)? 2) To what extent does the use of asynchronous telesonography increase the continuity of care for patients? 3) To what extent does the elapsed time between scanning and final radiological interpretation decrease with the use of asynchronous telesonography? This study will also look at the history of telemedicine / telesonography and its dissemination into the mainstream practice of medicine, explore training protocols that may be used to assist others to establish new telesonography programs in a developing nations, and discuss both advances and persistent barriers to the implementation of telesonography programs. Hypothesis: The use of a store-and-forward telesonography system in this setting will increase the speed and number of final diagnoses per scan received by the target clinic and will increase the continuity of care by increasing the number and speed of follow-up appointments to the target clinic.

NCT ID: NCT00590395 Completed - Cholecystitis Clinical Trials

FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis

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

This is a pilot study to investigate the ability of fluorodeoxyglucose-positron emission tomography (FDG-PET) and Positron emission tomography-computed tomography (PET/CT) as a direct method of detecting infection and/or inflammation of the gallbladder.

NCT ID: NCT00575276 Completed - Clinical trials for Cholecystitis, Acute

Study of Pain Perception Between Males and Females Following Laparoscopic Cholecystectomy

Start date: August 2006
Phase: N/A
Study type: Observational

This study looks at the differences in inflammatory mediators in gallbladder tissue between males and females and the possibility that these differences contribute to a higher perception of post-operative pain in females following laparoscopic cholecystectomy.

NCT ID: NCT00565682 Completed - Clinical trials for Laparoscopic Surgery for Cholecystitis

Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Start date: April 2006
Phase: Phase 4
Study type: Interventional

To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the already known effect when administered after such a procedure. Patient will be receiving either etoricoxib or the respective placebo one hour before surgery, then two hours after those receiving the active will receive placebo and those that received placebo will be given etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be available all the time.