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Cholecystitis clinical trials

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NCT ID: NCT04874103 Completed - Clinical trials for Cholecystitis, Acute

Hong Kong Follow up Protocol After EUS Gallbladder Drainage for Acute Cholecistitis

Start date: May 6, 2020
Phase:
Study type: Observational

This study evaluates the long-term safety and efficacy of the Hong Kong follow up protocol in patients who will undergo drainage of the gallbladder under endoultrasonography (EUS) guidance in patients with acute cholecistitis not suitable for surgery.

NCT ID: NCT04838379 Completed - Appendicitis Clinical Trials

Ultrasound Guided Rectus Sheath Block and Transversus Abdominis Plane Block

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The current study aimed to assess the efficacy of Dexmedetomidine (DEX) and Dexamethasone as an adjuvant to ultrasound guided TAP and RS block to prolongation of postoperative analgesia and better pain control in children undergoing laparoscopic surgeries

NCT ID: NCT04808544 Completed - Quality of Life Clinical Trials

Naldebain for Pain Management of Laparoscopic Cholecystectomy

Start date: August 30, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Laparoscopic cholecystectomy is the most common surgical procedure for removal of the inflamed gall bladder or other gall bladder pathologies. There are more than 12,000 cases of cholecystectomy performed in Taiwan annually, and more than 85% of this procedure are undertook with laparoscopic techniques. Even with minimally invasive laparoscopic operation, patients may still suffer from postoperative wound pain, deep visceral or referred pain. About 80% of patients who received laparoscopic procedures complain of moderate-to-severe pain within the first day after cholecystectomy. Most importantly, up to 20% (range from 3 to 20%) of these patients complained surgical-related pain one year after operation and they require prolonged use of opioid to control chronic postoperative pain (CPSP). However, there are currently lack of clinical practice guidelines or recommendations for prevention of CPSP after laparoscopic abdominal surgery. Although regional block techniques (i.e. truncal block or intrathecal opioid) are considered as effective supplementary analgesic approaches to improve postoperative pain control, parenteral administration of analgesics remain as the mainstay for pain management of laparoscopic abdominal surgery. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is an extended-release dinalbuphine sebacate, and is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. A number of clinical studies have shown that single-dose of pre-operative intramuscular administration of Naldebain® provides significantly higher analgesic effect up to 1 week in hemorrhoidectomy and laparotomy surgery with a well-tolerated safety profile. Therefore, this PI-initiated randomized, double-blind, placebo-control trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in patients receiving laparoscopic cholecystectomy, and prevention of the development of CPSP after surgery.

NCT ID: NCT04803487 Completed - Clinical trials for Cholecystitis; Gallstone

Robotic Cholecystectomy Using the Chinese Micro Hand S Robot: A Controlled, Randomized, Prospective Clinical Study

Start date: December 3, 2019
Phase: Early Phase 1
Study type: Interventional

A single-blinded, prospective randomized parallel controlled clinical trial was designed and conducted from December 2019 to November 2020. 82 patients with a gallstone, gallbladder polyp and other benign gallbladder diseases were enrolled in this study. Finally, 82 patients were randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical robot group. Standard robot-assisted transabdominal cholecystectomy was conducted using the Micro Hand S robot or the da Vinci robot. The success rate of operation, assembly time, operation time, intraoperative hemorrhage, time to first flatus, postoperative pain, comprehensive complication index, resident time and patient satisfaciton were recorded. The aim of the study is to determine whether the newly developed Chinese Micro Hand S surgical robot results in non-inferiority outcomes in cholecystectomy compared with the prevalent da Vinci robot.

NCT ID: NCT04744441 Completed - Clinical trials for Acute Calculous Cholecystitis

Mortality Risk Estimation in Acute Calculous Cholecystitis: Beyond the Tokyo Guidelines

ACME
Start date: January 2011
Phase:
Study type: Observational

Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments, the complication rate of ACC is 20-55%, and the mortality rate is 0.5-15% in recent series. The Tokyo Guidelines (TG) advocate for different initial treatments of ACC with no clear evidence that all patients will benefit from them. The objective of the study is to identify the risk factors for mortality in ACC and compare them with TG classification. It is a retrospective cohort study conducted from January 2011 to December 2016 in a single center with a dedicated surgical emergency unit in a Metropolitan University Hospital in Barcelona, Spain. The analysis of the data was finished in March 2020. The study candidates comprised 963 consecutive patients with a diagnosis of ACC according to the TG18 and/or received a diagnosis of ACC in the Pathology report in those that an emergent cholecystectomy was performed. The study case definition was a 'Pure Acute Cholecystitis' (pure ACC); therefore, patients with any other concomitant diagnosis potentially influencing outcome (Postoperative cholecystitis, Acute Cholangitis, Acute Pancreatitis, Incidental Cholecystectomy, Acalculous Cholecystitis, Chronic Cholecystitis/Persistent Colic, Post-endoscopic retrograde pancreato-cholangiography, or Neoplasia) were excluded from the final analysis. Variables: Primary data were available from a prospective database maintained in File Maker v.12 (Mountainview, CA, USA), which included basic demographic data, type of interventions, sex, days of admission, and complications. Every record was completed by browsing the electronic patient record, adding laboratory and microbiology data, as well as antibiotic therapy, duration of procedure, additional procedures, and grade of acute cholecystitis according to the TG18 diagnostic criteria. Preoperative comorbidities were assessed using the Charlson Comorbidity Index and surgical risk by ASA classification. The type of initial treatment was classified as Surgical Treatment (Cholecystectomy either by laparoscopy or laparotomy) or Non-Surgical Treatment, which was either percutaneous cholecystostomy or intravenous antibiotics alone. The main outcome measure was the mortality after the diagnostic of ACC. In the patients that were discharged, 30 days after the diagnosis, if the patients was not discharged in 30 days, at any time during the same admission. Interventions: All patients received intravenous antibiotic therapy from the moment the diagnosis was formulated, according to a fixed protocol. Ultrasound-guided cholecystostomy was performed percutaneously with an 8-Fr catheter (SKATER ™, Argon Medical Devices, Rochester, NY, USA) by either transhepatic or transperitoneal insertion, at the discretion of the radiologist. Laparoscopic Cholecystectomy was performed according to the French technique using 4 trochars. The content of the gallbladder was evacuated by Veress needle puncture when necessary. Statistical Analysis: The normal distribution of the quantitative variables was assessed using the Kolmogorov-Smirnov test, which showed that none of the variables were normally distributed; therefore, their values were expressed as median and interquartile ranges. The Mann-Whitney U non-parametric test was used to assess the significance of differences between means. The association between qualitative variables was assessed with the chi-square test or Fisher's exact test, as required. The increased risk of an event associated with a variable was reported as the odds ratio (OR) and 95% confidence interval (CI). As this was a retrospective observational study and the treatment groups were markedly asymmetric, we used the propensity score matching method to select and compare two subgroups of patients evenly balanced by severity according to the TG18 criteria and by comorbidity according to the Charlson Comorbidity Index. A model for predicting mortality was built using binomial logistic regression with stepwise progressive conditional entry and standard baseline conditions for admission and rejection of variables with significant differences in the univariate analysis. The discrimination power of the model was assessed by receiver operating characteristic (ROC) curves and was compared with the DeLong method. Legal and Ethical considerations This study was approved by the clinical research ethical committee of the Hospital del Mar and was classified as a non-clinical trial.

NCT ID: NCT04726046 Completed - Cholecystitis Clinical Trials

Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

Start date: April 1, 2014
Phase: Phase 1
Study type: Interventional

529 patients performed elective LCC at Chonbuk National University Hospital between April 2014 and August 2015. Total 509 patients were enrolled by inclusion criteria. They were randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body temperatures, symptoms and imaging of chest x-ray to evaluate the infections.

NCT ID: NCT04723043 Completed - Clinical trials for Mechanical Ventilation Pressure High

The Effect of Ventilation Modes on Cerebral Oxymetry In Operation

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

In laparoscopic cholecystectomy method, Insufflation of CO2 in abdominal cavity causes positioning of the diaphragm upwards, a decrease in lung's volume and its compliance, an increase in the airway resistance, mismatch between the atelectasis and the ventilation perfusion. Although there are numerous studies in laparoscopic surgery, only a few of them investigate the effects of laparoscopic surgery on the cardiopulmonary and the respiratory mechanics. The investigator aimed To examine the effects of pressure-controlled and volume-controlled ventilation modes on cerebral oximetry and blood gases in laparoscopic cholecystectomy operations.

NCT ID: NCT04716166 Completed - Cholecystitis Clinical Trials

Incentive Spirometry and Upper Abdominal Laparoscopic Surgery

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

To compare the effects of volume-oriented versus flow-oriented incentive spirometry on pulmonary function tests and functional capacity in patients of upper abdominal laparoscopic surgery. Previous studies were designed to target only spirometer without focusing on its different types and their effects. This study covers the research gap and therefore is designed to observe effects of different types of spirometer on pulmonary function of patients undergoing upper abdominal laparoscopic surgery.

NCT ID: NCT04672902 Completed - Cholelithiasis Clinical Trials

Treatment of Mirizzi Syndrome

Start date: November 1, 2020
Phase:
Study type: Observational

Mirizzi syndrome is an infrequent complication of long-standing cholelithiasis. Extrinsic compression of the common hepatic duct is usually caused by an impacted stone in Hartmann's pouch or cystic duct resulting in the development of cholecystobiliary fistula. This syndrome is classified based on the presence and severity of cholecystobiliary fistula. Mirizzi syndrome is challenging to diagnose preoperatively and may require complex biliary surgical procedures for resolution. Endoscopic treatment is a safe alternative with a high success rate. Single-operator cholangioscopy combined with lithotripsy has been shown to have a 90-100% success rate in the treatment of biliary stones. Herein, A single center experience treating Mirizzi syndrome with single-operator cholangioscopy guided electrohydraulic lithotripsy is presented. Difficult management of Mirizzi syndrome has led to research of new treatment options to minimize the risk of high rate complications. Single-operator cholangioscopy in combination with laser lithotripsy is an adequate and safe alternative for the treatment of this condition.

NCT ID: NCT04602156 Completed - Cholecystitis Clinical Trials

US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy

TROSELCII
Start date: September 16, 2020
Phase: N/A
Study type: Interventional

A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy