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C S L C I E N N I A C R A I L O

TREATMENT. What intervention will best treat acute cholecystitis in patients at high risk for surgery?. C S L C I E N N I A C R A I L O. Search Terms: (PubMed). Population – high surgical risk patients Intervention – therapy Outcome – treatment of acute cholecytitis.

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  1. TREATMENT What intervention will best treat acute cholecystitis in patients at high risk for surgery? C S L C I E N N I A C R A I L O Search Terms: (PubMed) Population – high surgical risk patients Intervention – therapy Outcome – treatment of acute cholecytitis Percutaneous Cholecystostomy Versus Gallbladder Aspiration for Acute Cholecystitis: A Prospective Randomized Controlled Trial American Journal of Roentgenology 2004, July; 183(1):193-196 Kei Ito, Naotaka Fujita, Yutaka Noda, Go Kobayashi, Katsumi Kimura, Toshiki Sugawara, Jun Horaguchi Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, Miyagi 983-0824, Japan.  S E A R C H

  2. Is the objective of the article on harm similar to your clinical dilemma? • Yes. The population of the study includes institutionalized patients for acute cholecystitis.(Objective 3rd line. Subjects and methods lines 1-3 pg.193) • The study compared the effectiveness and incidence of complications of percutaneous cholecytectomy and gall bladder aspiration. (Objective lines 1 -3, pg 193). • Good clinical response was obtained in 27 patients (90%) of the percutaneous cholecystectomy group and in 14 patients (61%) of the gall bladder aspiration group (p<0.05) (Results lines 5 - 7 pg 193). There were no major complications or procedure- related deaths in either group.(Results last sentence pg 193) The overall complication rate of 3% in percutaneous cholecystostomy is low compared with previously reported rates of 4–24%(Discussion 4th paragraph lines 27-29 pg 195) R E L E V A N C E

  3. Was it randomized? Was randomization concealed? • The patients included were randomized into either the percutaneous cholecystostomy group or the gallbladder aspiration group by means of the sealed envelope method after written informed consent had been obtained. (Subjects and methods 2nd paragraph lines 1-5 pg 194) • A prospective randomized controlled trial was done to compare and determine the effectiveness and safety of percutaneous cholecystostomy and gallbladder aspiration in cases of severe acute cholecystitis.(Discussion 4th paragraph lines 1-5 pg 195) Was the follow-up sufficiently long and complete? V A L I D I T Y G U I D E S • 203 patients with acute cholecystitis were admitted. Of those 203 patients, 84 patients improved with antibiotic treatment. • Sixty-one patients were excluded on the basis of the exclusion criteria (refused consent,n= 48;pericholecystic liver abscess,n= 11;coagulopathy;n= 2). • Those patients underwent either percutaneous cholecystostomy or gallbladder aspiration except one patient who underwent emergency cholecystectomy because of spontaneous perforation of the gallbladder. • The results were analyzed per protocol; all patients who underwent percutaneous cholecystostomy after gallbladder aspiration as a salvage procedure were included in the analysis.(Statistical Analysis 2nd paragraph lines 1-4)

  4. Was the data analyzed on an intention-to-treat basis? • Yes. No crossing over of treatment were done. The patients were all attributed to the group which they were randomized. • Of the 58 patients included, 30 were randomized to the percutaneous cholecystostomy group and 28 to the gallbladder aspiration group (Fig. 1).(Results 1st paragraph sentences 1-5 pg 194) Was there adequate blinding of subjects and researchers? V A L I D I T Y G U I D E S • Blinding is not possible, since this is a surgical trial.Although, outcome events were assessed by investigators or adjunction committess who are not directly involved in the trial. • Percutaneous cholecystostomy was performed by puncturing the gallbladder with an 18-gauge needle under sonographic guidance, followed by deployment of a 6.5- or 7-French pigtail catheter using the Seldinger technique. • Gallbladder aspiration was carried out with a 21-gauge needle under sonographic guidance. The needle was removed immediately after aspiration of gallbladder contents. Both procedures were performed by trained gastroenterologists. This study was approved by the institutional review board.(subjects and methods 2nd sentences 2-5)

  5. Were there similar baseline characteristics in each group? Patient characteristics of the two groups were comparable except for a higher proportion of patients with leukocytosis and its degree in the percutaneous cholecystostomy group( Results 2nd paragraph 4th sentence pg 194) Groups treated equally other than intervention? V A L I D I T Y G U I D E S • Those patients underwent either percutaneous cholecystostomy or gallbladder aspiration except one patient who underwent emergency cholecystectomy because of spontaneous perforation of the gallbladder. (Results 2nd paragraph 2nd sentence pg 194)

  6. How large was the treatment effect? Control = gallbladder aspiration (GA) Treatment = percutaneous cholecystotomy (PC) Death = failure to clinically respond within 72 hours p. 194, Results C L I N I C A L I M P O R T A N C E How precise is the estimate of the treatment effect? Confidence interval was not indicated. However, the reported p-value was p < 0.05, therefore, results are acceptable. p. 194, Results

  7. Can the results be applied to my patient care? A P P L I C A B I L I T Y Yes, the results can be applied to our patient care. The patient meets most of the inclusion criteria and none of the exclusion criteria. However, presence of co-morbid conditions in the study population was not indicated. p. 193, subjects and methods Were all clinically important outcomes considered ? The main clinical parameter used in the study was good clinical response within 72 hours of intervention (surrogate endpoint), which improved safety of elective surgery (cholecystectomy). Thus, yes, indirectly, clinically important outcomes were considered. p. 194, Results

  8. Is treatment feasible? Yes, percutaneous cholecystotomy is available in the Philippines Patient preferences Percutaneous cholecystotomy is only a temporizing option in a seriously ill patient, and this should still be followed by cholecystectomy. But given that the patient is 89 years old with co-morbid conditions, the quality of life granted by this procedure until the need for cholecystectomy is warranted, might be enough. A P P L I C A B I L I T Y Benefits vs. Harms Current experience suggests that interventional radiological drainage can be performed without increasing the overall mortality rate. However, percutaneous cholecystotomy does not obviate the need for ultimate surgical removal of the gallbladder.

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