ABSTRACT
ABSTRACT Background: Reports in the literature describe lymphocele formation in up to half of patients following pelvic lymph node dissection (PLND) (1) in robotic-assisted radical prostatectomy (RARP), with 1-2% requiring intervention (2). The advantage of surgical approach is permanent excision of the lymphocele capsule and fewer days with pelvic drains compared to percutaneous drainage. This study aims to describe the step-by-step surgical management of symptomatic lymphoceles using a less invasive robotic platform, the Da Vinci® Single Port (SP). Material and Methods: We describe the technique of lymphocelectomy and marsupialization with the Da Vinci® SP for symptomatic lymphocele. For this study, several treatment modalities for symptomatic lymphoceles were available, including percutaneous drainage, sclerosing agents, and surgical marsupialization. All the data for this study were obtained through the procedure via Da Vinci® SP. Results: Operative time for the case was 84 minutes. Blood loss was 25ml. No intra- or post- operative complications were reported. The patient had his drain removed in under 24 hours after surgery. The mean follow-up period was 7.7 months. There were no complications or lymphocele recurrence. Conclusion: Da Vinci® SP lymphocelectomy is safe and feasible with satisfactory outcomes. The SP enables definitive treatment of the lymphocele sac (3), reducing the number of days with abdominal drains and allows further decrease in surgical invasiveness with fewer incisions and better cosmesis.
Subject(s)
Humans , Male , Robotics , Lymphocele/surgery , Lymphocele/etiology , Robotic Surgical Procedures/adverse effects , Prostatectomy/methods , Drainage/adverse effects , Drainage/methods , Lymph Node Excision/methodsABSTRACT
Introduction: cleaning validation is an integral part of current good manufacturing practices in pharmaceutical industry. The main purpose of cleaning validation is to prove the effectiveness and consistency of cleaning in a given pharmaceutical production equipment to prevent cross contamination and adulteration of drug product with other active ingredient. Objective: a rapid, sensitive and specific reverse phase HPLC method was developed and validated for the quantitative determination of irinotecan hydrochloride in cleaning validation swab samples. Method: the method was validated using waters symmetry shield RP-18 (250mm x 4.6mm) 5 µm column with isocratic mobile phase containing a mixture of 0.02 M potassium di-hydrogen ortho-phosphate, pH adjusted to 3.5 with ortho-phosphoric acid, methanol and acetonitrile (60:20:20 v/v/v). The flow rate of mobile phase was 1.0 mL/min with column temperature of 25°C and detection wavelength at 220nm. The sample injection volume was 100 µl. Results: the calibration curve was linear over a concentration range from 0.024 to 0.143 µg/mL with a correlation coefficient of 0.997. The intra-day and inter-day precision expressed as relative standard deviation were below 3.2%. The recoveries obtained from stainless steel, PCGI, epoxy, glass and decron cloth surfaces were more than 85% and there was no interference from the cotton swab. The detection limit (DL) and quantitation limit (QL) were 0.008 and 0.023 µg ml-1, respectively. Conclusion: the developed method was validated with respect to specificity, linearity, limit of detection and quantification, accuracy, precision and solution stability. The overall procedure can be used as part of a cleaning validation program in pharmaceutical manufacture of irinotecan hydrochloride.