AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
CholecystitisAcuteTo evaluate the safety and effectiveness of the AXIOS™ Stent with Electrocautery Enhanced Delivery System in the management of symptoms of acute cholecystitis as an alternative to percutaneous gallbladder drainage.
M-Tapa Block vs External Oblique Intercostal Block for Laparoscopic Cholesistectomy
CholecystitisCholecystitis1 moreUltrasound (US)-guided Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia in the anterior and lateral abdominal walls after laparoscopic surgery, and local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall and may be an opioid-sparing strategy with good quality recovery in patients undergoing laparoscopic surgery. US-guided External oblique intercostal block (EOB) is a block performed by injection of local anesthetic between the external and internal oblique muscles. This block provides abdominal analgesia between T6-T10 levels. There are studies in the literature showing that it provides effective analgesia. However, there is no study comparing M-TAPA and EOB yet. In this study, our aim is to compare the effectiveness of US-guided M-TAPA block and EOB for postoperative analgesia management after laparoscopic cholecystectomy surgery. Our primary aim is to compare patient recovery scores (QoR15 Turkish version), our secondary aim is to compare postoperative pain scores (24-hour NRS), postoperative rescue analgesic use (opioid), and opioid-related side effects (allergic reaction, nausea, vomiting).
Subserosal Laparoscopic Cholecystectomy
CholecystitisThe aim is to study the safety and efficacy of subserosal laparoscopic cholecystectomy .
M-Tapa Block for Laparoscopic Cholesistectomy
CholecystitisCholecystitis3 moreModified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall, and may be an opioid-sparing strategy with satisfactory quality improvement in patients undergoing laparoscopic surgery.
Vitamin C Efficacy in Reducing Post Operative Pain
Gallbladder InflammationOpioids are the corner stone in the treatment of post operative pain. Because of the several side effects of opiods, non-steroidal anti-inflammatory drugs are usually added postoperatively to decrease the total requirements of opioids. However, non steroidal anti-inflammatory drugs have side effects of their own. Vitamin C, with virtually no side effects when used on short-term basis, has been shown to have promising analgesic effects in chronic pain and acute pain relief following orthopedic surgeries. The investigators propose to assess the role of a prophylactic single dose (2g) of vitamin C in reducing the intensity of pain and the consumption of opioids in patients undergoing laparoscopic cholecystectomy at AUB-MC. All eligible patients undergoing laparoscopic cholecystectomy at AUB-MC will be included in the study. Patients will be randomized into two groups to receive either single dose oral vitamin C (2g) (Study Group) or identically looking placebo capsules (Control Group). Both the patients and the investigation team will be blinded to the type of intervention. Intraoperative anesthesia management will be similar for both groups. Postoperative pain control will be achieved with patient controlled analgesia via a patient controlled morphine pump in both groups. At several time intervals and up to 24 hours postoperatively, the pain scores, morphine consumptions, nausea/vomiting scores, sedation scales, itching scales, and patient satisfaction scales will be obtained for all patients. Also, the peak vitamin C concentration will be determined for each patient. Patients demographics will be obtained and compared between both groups. The differences in pain scores, morphine consumptions, nausea/vomiting scores, and sedation, itching, and patient satisfaction scales will be compared between the two groups with the Student-t test, the analysis of variance, the Fisher exact test, and the Kruskal-Wallis test. The peak vitamin C plasma concentration will be correlated with the pain scores in each group using regression analysis. This study will provide relevant information on whether a single dose (2g) of vitamin C can reduce morphine requirements and non steroidal anti-inflammatory drugs need and thus eliminating their side effects in patients undergoing laparoscopic cholecystectomy.
Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis
CholecystitisIn 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.
Cholecystitis From a Microbiological and Histopathological Perspective
Calculous CholecystitisAntibiotic Resistant Infection1 moreThe aim of this project is to investigate the presence of bacteria in the gallbladder wall and the bile in patients undergoing cholecystectomy, to determine if the standard empirical antibiotic treatment used currently is effective against the most common pathogens.
Effect Of Early Versus Delayed Laparoscopic Cholecystectomy In Patients With Grade II Cholecystitis...
CholecystitisThe timing ofthe cholecystectomy in patients with acute cholecystitis is still controversial. In our study, we aimed toinvestigate the effect of early and delayed cholecystectomy on difficultcholecystectomy, morbidity and mortality in patients diagnosed with Grade IIcholecystitis according to Tokyo 2018 guidelines.
Effects of Drainage in Laparoscopic Cholecystectomy
Acute CholecystitisEmpyema of Gallbladder1 moreDuring laparoscopic surgery for an acutely inflamed gallbladder, most surgeons routinely insert a drain. However, no consensus has been reached regarding the need for drainage in these cases, and the use of a drain remains controversial. This study is coordinated to find out the surgical outcomes and perioperative morbidity according to the insertion of drain after laparoscopic cholecystectomy. Investigators expect that the routine use of a drain after laparoscopic cholecystectomy for an acutely inflamed gallbladder will have no effects on the postoperative morbidity.
3D Versus 4K Laparoscopic Cholecystectomy
CholecystitisGallstonesIntroduction: Three-dimensional key-hole surgery ('laparoscopic') systems are proven to reduce the time required to complete tasks in laboratory settings. This benefit derives from the addition of binocular depth perception cues when compared to two-dimensional (2D) systems. This year a '4K' laparoscopic system has become commercially available, so-named as it provides a high resolution 2D image with four times the number of pixels of 2D full high definition. The improved visualisation is likely to provide additional non-binocular depth cues. It is currently unclear to what degree improving the resolution of 2D systems can compensate for binocular depth cues. Aim: To determine whether the binocular vision provided by 3D laparoscopic systems provides benefits during laparoscopic cholecystectomy when compared to the monocular vision provided by high-resolution 4K systems. Methods: A randomised controlled trial of 3D HD versus 4K laparoscopic systems will be performed, comparing the time to complete laparoscopic cholecystectomy, and error scores. Impact: This study is a unique, first-of-its-kind investigation into two new surgical technologies, and is the first study to involve a 4K system. The uptake of three-dimensional systems has been curbed by financial cost and the limitations of early 3D technologies. This study aims to determine which system may be the safest, quickest and most cost- effective, in order to guide future investment and technological development towards either 3D or 2D systems. In addition, these systems may also aid in the learning curve of trainee surgeons.