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Cholecystitis, Acute clinical trials

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NCT ID: NCT06074679 Recruiting - Clinical trials for Cholecystectomy, Laparoscopic

Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis

Start date: September 30, 2023
Phase: N/A
Study type: Interventional

Gallstone is a common disease in China.At present, the prevalence of gallstones in China is 15 %, and about 210 million people are sick. Acute cholecystitis is acute gallbladder inflammation, is one of the main complications of cholelithiasis or gallstones. The removal of gallbladder and gallstones in patients with acute cholecystitis in the presence of biliary pain will prevent the recurrence of gallbladder and reduce the risk of cholecystitis progression. If gallbladder perforation is not treated in time, the mortality rate is 30 %. Acute acalculous cholecystitis without treatment will be life-threatening, with a mortality rate of up to 50 %. At present, the vast majority of patients with acute cholecystitis are treated with 4-hole traditional laparoscopic cholecystectomy and open cholecystectomy. Their postoperative quality of life, pain and scar-related complications, remain major factors for patients.In recent years, with the renewal of the concept of minimally invasive surgery and the continuous advancement of instruments and technology, single-incision laparoscopic cholecystectomy has also maximized the quality of life after surgery and reduced postoperative pain and scar-related complications. At present, there are few reports on randomized controlled clinical trials of SILC in patients with acute cholecystitis, and there is a lack of large sample size studies.Due to the difficulty of SILC operation, the longer learning curve, the different equipment conditions and technical characteristics of each center, and the lack of standardized training, there is no effective consensus on the application indications and operation procedures of SILC in acute cholecystitis surgery. Based on the current status, the purpose of this study was to investigate the effect of SILC on postoperative quality of life, postoperative pain, scar assessment and postoperative complications in patients with acute cholecystitis, so as to propose a standardized single incision laparoscopic operation procedure in the treatment of acute cholecystitis.

NCT ID: NCT06011941 Not yet recruiting - Clinical trials for Common Bile Duct Calculi

Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques. Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube. Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube. Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.

NCT ID: NCT05975385 Recruiting - Pain, Postoperative Clinical Trials

Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Start date: October 9, 2023
Phase: N/A
Study type: Interventional

The purpose is to find out if intraoperative acupuncture performed by needling PC 6 and LI4 point bilaterally, and Yin Tang point will help reduce the incidence postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic regimen consisting of ondansetron and dexamethasone. The hypothesis is that the addition of this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when compared to patients receiving ondansetron and dexamethasone without acupuncture.

NCT ID: NCT05893511 Recruiting - Acute Cholecystitis Clinical Trials

EUS-GBD vs Antibiotics for Patients at High Risk for Cholecystectomy

Start date: April 26, 2023
Phase: Phase 3
Study type: Interventional

Objectives Acute cholecystitis commonly occurs in elderly patients who are at high-risk for surgery. Whether upfront Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is advantageous over antibiotics first for mild acute cholecystitis is uncertain. Hypothesis to be tested The aim is to compare EUS-GBD versus standard protocol (antibiotics first) as a definitive treatment, in very high-risk patients suffering from mild to moderate acute cholecystitis. We hypothesize that EUS-GBD can reduce the 1-year risk of recurrent acute cholecystitis. Design and subjects This is an international randomised controlled study including consecutive patients suffering from acute cholecystitis that are very high-risk for cholecystectomy. The patients would be randomized to receive EUS-GBD or antibiotics first. Interventions: EUS-GBD versus antibiotics Main outcome measures: The primary outcome is the rate of recurrent acute cholecystitis in 1 year. Other outcomes include technical and clinical success, post-procedural pain scores, analgesic requirements, adverse events, re-admissions, re-interventions, quality of life and cost analysis. Data analysis All outcomes would be analysed according to the intention-to-treat principle. Kaplan-Meier method with the log-rank test will be used to compare differences in recurrent acute cholecystitis in 1 year. A health economic analysis will also be performed. Assuming a 17.1% difference in recurrent acute cholecystitis rates, a 2-sided P value of 0.05, a power of 80%, and a 10% dropout rate, 110 patients is required. Expected results The findings of this study can help establish the role of EUS-GBD in management of high-risk patients suffering from acute cholecystitis over antibiotics alone and Percutaneous transhepatic gallbladder drainage.

NCT ID: NCT05848726 Completed - Child, Only Clinical Trials

Laparoscopic Cholecystectomy Using Airseal in Children

VBAS
Start date: January 1, 2021
Phase:
Study type: Observational

The goal of this observational study is to compare the use of Airseal versus a standard insufflation, in children who underwent laparoscopic cholecystectomy, between January 2021 and December 2022. The main questions it aims to answer are: - amount of analgesics consumed postoperatively - mean digital pain scale Data are directly extracted from patients medical files. The investigators will compare the Airseal group (A group) to the Standard insufflation group (S group) to see if the A group consumes significatively less analgesics and are less painful than the S group.

NCT ID: NCT05744999 Completed - Cholecystectomy Clinical Trials

HOW TO PERFORM SAFELY CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS

Start date: January 1, 2021
Phase:
Study type: Observational

The aim of this manuscript is to illustrate a new method permitting safe cholecystectomy in terms of complications with respect to the common bile duct (CBD). The core of this new technique is identification of the continuity of the cystic duct with the infundibulum. The cystic duct can be identified between the inner gallbladder wall and inflamed outer wall. In the last 2 years, 3 patients have been treated with the reported technique without complications. Among the various cholecystectomy procedures, this is a new approach that ensures the safety of the structures of Calot's triangle while providing the advantages gained from total removal of the gallbladder.

NCT ID: NCT05736003 Completed - Acute Cholecystitis Clinical Trials

Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Gallbladder stone affects 10-15% of the adult population, and about 15-25% of these patients presented with acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is considered the treatment of choice for patients with AC, and recent studies suggest that early laparoscopic cholecystectomy (ELC) is preferable. However, the optimal time for ELC in AC is still controversial. Early laparoscopic cholecystectomy (ELC) was advised for patients presented within 72 hours, while conservative treatment and planned delayed laparoscopic cholecystectomy (DLC) after six weeks was recommended for patients presented after 72 hours. Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone for the DLC.

NCT ID: NCT05732480 Recruiting - Pancreatitis Clinical Trials

Influence of Gut Microbiome in Gallstone Disease

Start date: May 30, 2023
Phase:
Study type: Observational

The goal of this prospective observational study is to explore the role of the gut microbiome in patients with gallstone disease. The main question[s] it aims to answer are: - if there is a relationship between the gut microbiome and the development of complications associated with gallstone disease (such as pancreatitis and acute cholecystitis) - if there are changes in the gut microbiome following cholecystectomy and the relationship with patient outcomes. Participants will be asked to provide stool samples at fixed time points (recruitment, pre- and post-cholecystectomy if applicable and at 6 months and 3 years. They will also be asked to provide stool samples if they represent to hospital with complications associated with their gallstone disease.

NCT ID: NCT05728073 Completed - Clinical trials for Cholangiopancreatography, Endoscopic Retrograde

Does Subtotal Cholecystectomy Rate for Acute Cholecystitis Change With a Previous ERCP?

Start date: December 10, 2022
Phase:
Study type: Observational

Study is designed to investigate whether the history of ERCP is associated with subtotal cholecystectomy rates in patients underwent laparoscopic cholecystectomy operations with the diagnosis of acute cholecystitis.

NCT ID: NCT05709548 Recruiting - Acute Cholecystitis Clinical Trials

Use of Indocyanine Green in Acute Cholecystitis

INDURG
Start date: March 15, 2023
Phase: Phase 4
Study type: Interventional

Laparoscopic cholecystectomy is one of the most common gastrointestinal surgeries. However, it can be technically complex in those patients diagnosed with acute cholecystitis who present severe inflammation or fibrosis, with bile duct injury being one of its main complications. The use of fluorescence cholangiography through the use of indocyanine green allows the identification of extrahepatic biliary structures, facilitating dissection and reducing the risk of bile duct lesions. Better visualization of the bile duct allows reducing the conversion rate to open surgery, as well as operating time. The main objective is to assess a decrease in operating time in acute cholecystitis undergoing emergency surgery, to which indocyanine green is administered preoperatively. Randomized, prospective, controlled, multicenter clinical trial of two groups of patients diagnosed with acute cholecystitis and requiring urgent cholecystectomy. The control group includes 220 patients who undergo urgent laparoscopic cholecystectomy according to the usual technique without the administration of indocyanine green, and the intervention group includes 220 patients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively. Study led by the Parc Taulí University Hospital in Sabadell.