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Okay, so today we will discuss a paper called acute Colitis Itis early versus delayed college cystectomy a multi center randomized trial. So why did we choose this paper in all these guidelines that were created together? Withdrawal College of Surgeons, It states that patient's is acute Cult cystitis should ideally have a lab collie during the same admission or within the seven days. Um, in reality, it's a bit difficult to maintain the standard. It all depends on availability of the operating theaters. And sometimes in countries like us or UK, um, people prefer to do delayed, uh, love coli and organized an elective one. So this study, um, it compares to approach is so early cholecystectomy versus delayed one, uh, so initiated in conservatively with antibiotics until complete resolution of inflammation. And then the lab colleagues followed several weeks later. There have been multiple studies done on this same issue. Uh, but the controversy still exists. So and why do we think the controversy still exists? Because there is only a limited number of prospective studies and they are usually small size uh, the definition of the early versus late cholecystectomy virus Between the study antibiotics regime also arise, and also the outcomes are not well defined. Always, uh, methods. Their aim was to define the best practice for the treatment of acute cholecystitis. This study, a CDC it's called, was designed to compare 75 day morbidity in patient's with a cuticle cystitis who were randomly assigned to immediate lab collie or too conservative approach with antibiotic treatment and subsequent elective lab collie. So delayed lab quality. Not going to be two groups immediate, like poly and delayed like college. So who were eligible adult patient's with at least three of the following. So abdominal pain in the right upper quadrant. Murphy Sign Lucas. I told this and temperature above 38 who has a proven colored cystitis with sonography or any signs of cold cystitis exclusion criteria. We're, uh, say four and five. So it's a It's a marker of really high burden of chronic chronic disease, and they're really high operative risks of people wouldn't operate on them necessarily. They probably will put cholecystostomy so they were excluded. Uh, septic stroke preventing septic shock preparation or abscess of the gold bladder. Uh, no possibility for lab surgery. Life life expectancy of less than 48 hours pregnancy or breastfeeding and any con country indication to the antibiotics that was chosen to be moxifloxacin, which is a very broad spectrum and strong antibiotic. So it was multi centered, prospective and randomized. Random ization was performed with the block side of four in the 1 to 1 manner. So this is all green for me? Sounds good. However, it wasn't stated whether assesses were blind. Participants obviously won't be blinded. But whether assesses were blinded or blind blinded, it hasn't been stated anywhere in this study. Neither in the protocol. So there. As I said, there were two treatment groups ls and dealers so immediate and delayed. Uh, in I l s group, um, people underwent called texting movies in 24 hours of hospital admission. That is important. It's a hospital. Admission, not symptoms on sad um they were discharged as soon as possible after the first post operative day. An antibiotic has been given IV moxifloxacin once a day for 48 hours that was switched to order form after and then test occur or a visit has been performed on day 75 to assess the morbidity using a predefined mobility scheme. So in DLS people were treated with IV slash oral moxie focusing. But again, at least 48 hours have been I've seen, uh, patient's who are discharged as soon as possible. Um, after this inflammatory markers were going down and then elective lab call has been scheduled with the timeframe of day 7 to 45 and they used a single shot prophylaxis, prophylaxis of ivory moxifloxacin and again, test of curve is it has been performed Monday 75. Their primary outcomes, uh, were to assess morbidity within 75 days in the both group and secondary outcomes. Um, so the one mentioned in red are those that are stated in the protocol but not stated in the actual paper. So secondary outcomes mobility After 75 days, rate of conversion from lab to open surgery, change of antibiotics, mortality, cost and cost effectiveness. Overall length of hospital stay and length of hospital stay after cholecystectomy. So what haven't been mentioned is mobility. Three days after constectomy, which kind of personally don't think matter that much. And safety of moxifloxacin. Although they did report some of the side effects of these drugs, the safety hasn't been assessed. They did have a good statistics, they calculated power and they decided that the sample size of 640 for patient's as needed. Um, they performed primary statistical analysis on per protocol population. However, they also performed I T T and and sensitivity analysis to and Sensitivity analysis was performed on confounding factors such as gender or comorbidities. So what are pretty good? So then our results. There have been 35 study centers involved in Germany in Slovenia over four years, and the last patient was assessed in 2010. So if we can see 618 people were randomized to two groups, so overall it's only under powered by 4% which is a very small amount. So 304 versa. And two ls uh, I'll see Rather and 314 were assigned to D. L. C Overall dropout percentage has been in I L C 4% in D. L. C 18% and the reason for drop outs are stated here. So there is some discrepancy in random ization between the groups, and we can also see that there are some baseline imbalances. For example, in gender. There more females in the IOC group is compared with you see, And there's also discrepancies in the comorbidities like, um, but overall, it's actually like, not too bad. Uh, interestingly, for example, previous intra abdominal surgery, which obviously affects adherents and everything else and the difficulty of the your laparoscopic surgery has been lower in the IOC group as compared to the D L C group. That's just something interesting. So again, we can already tell risk of bias. I think random ization has a low risk because, um, it's been concealed and its use some random methodology and deviation from intending intervention. So when comparing to the protocol, I couldn't find any deviations. And the only minor deviation that was possible to find is that in the GLC Group, not everyone uh received this Prophylaxis IV more moxifloxacin shot before their elective surgery. But I would not be confident enough to say that it will somehow affect the overall outcomes, although it may so results Morbidity occurred in 35 Patient's of I. L C. Group A K 12% and an 86 patient's of DLC group take a 33% of the per protocol population analysis of the I t t. Confirmed that, too, in both groups. Patient's with a higher a say status had more and morbidity, which makes sense. And again, it's been supported by I t t analysis, too. So apologies I'm not sure the minority score should have removed it. So mean total length of hospital stay in I'll see group. It's been 5.4 days in in the d. L C group between 10 days, which also makes sense because you keep them firstly initially in hospital for the acute attack. And then you keep them in the hospital for the source control, which is not quite so length of hospital stay after the lab. Poly has been about the same in both groups. Um, the antibiotics has been changed in 22 Patient's in IOC group and Torture plantations and DLC group. I mean, it's pretty similar cost, of course, cost were higher by 46% in D L C. Group because there have been a longer hospital staying and it's expensive. Um, adverse event did occur, so there were 58 adverse events among 43 patient's in the I'll See group and 179 adverse events amongst 127 patient's in the D L C group, and most of them were associated with the acute code societies itself rather than with the surgery. Um, So, for example, in the DLC croup, 100 of and 20 which is a majority of 16% of the adverse events, occurred before cholecystectomy even happened. So and in fact, the adverse events have been the main reason for the premature surgery. So there have been a few premature surgeries, so surgeries performed less than seven days because of the adverse events. A sensitivity analysis has also been performed because female gender, as we said and some other common bridges were not balanced. So several sensitivity analysis were performed to investigate whether these imbalances impact the outcome. Um, and what? They found out that only in patient's with less common comorbidities such as respiratory insufficiency and heart failure, immediate cholecystectomy was not demonstrated to be superior to conservative approach. Basically, um, people with respiratory cardiac capability do not benefit from the immediate cholecystectomy, rather, the benefit from antibiotic and concert conservative treatment first, which also kind of makes sense. That's why there's always a say category in place. And there is always a judgment whether the person is fit for surgery in general or whether we need to make him fit medically fit. So, uh, regarding risk of bias to continue with the missing outcome data. I think it's been pretty low risk because the outcome data has been reported for all participants because they did perform 90 t analysis. And I don't think there have been any missing data apart from safety of more mm, more of the antibiotic. But again, I'm not sure whether it somehow will affect the outcome. All the analysis. So, uh, as of measurement of the outcome, I put some concerns. And because A the outcome assesses we're not blind blinded. Well, at least it's not stated that they were blinded. So I assume they weren't. And it potentially that it can affect the results. And it can affect the analysis. Um, so a selection of the reported result I think it's been low risk because the trial did run according to the plan, with only one single protocol violation, which is not giving, not always giving, uh, the Prophylaxis IV antibiotic before, um, elective flap calling, which I don't know. I don't know whether it will make any big difference or not. So discussion. So what's been proven is that immediate cholecystectomy is associated with statistically significant less morbidity. Associated is also shorter hospital stay and lower costs than the conservative approach. The mortality has been the same in both groups, which is 0.3%. This study is characterized by the randomized design which you've seen and a good sample size. It's been sufficient because they've covered it. Um, one thing I didn't do is I didn't check whether they calculated the power correctly, but you can easily do it online If you type our calculator online, um, you can recalculate everything. So it has better patient's characterization because it included systemic and chronic diseases. In a say grading, they did provide an effective antibiotic treatment, and they did, uh, standardize the methods for evaluation of the outcomes. They do have a form they used for mobility assessment and conservative approach is associated with the risk that even using an effective antibiotic treatment signs and symptoms of ocucoat, the studies may not resolve, or they may reappear quite shortly after resolution, and eventually this leads to prolonged hospitalization and surgery under more difficult conditions and higher cost. Why? Because, um if the person continues to deteriorate there, obviously in the worst state that they were on day one limitations. So one of the limitations the study mentioned itself is that they had two very distinct approaches in operation. So because obviously one is the operating certain operates on inflamed gallbladder, the other approach is slightly different because the gallbladder is not as inflamed. And, um, I guess what they mean is that this set of skills has to be a little bit different. But overall, the experience and senior surgeon, I don't think it will matter to him. Um, so some of the patient's in the GLC groups have been operated before the schedule before Day seven, but it's because of the persistent signs and symptoms. Uh, onset has not been onset of symptoms has not been recorded. So they used hospitalization at the baseline to start counting, which, I mean makes sense because onset of symptoms, it's quite subjective. And people can tell you're I've been having it for two weeks, so you already cannot randomly assign them, but it's it is limitation and I understand if everyone would present with, like with a heart attack with everyone present. Actually, within the first day, it will make your life a bit easier for everyone. Um, And again, the common ridges are not balanced between treatment groups. So and some things to think about it again. The comfort of the surgeons. What do what do they prefer? They prefer to operate on the acute gallbladder, Or do they prefer to wait? I mean, it's depends on their training. And, um Well, how were the And they went the training? Um, we'll also, with matter, if we will blind the assessor. And the last point which I didn't put here is what about the resources? Because it's not always available to perform lab collie in the 1st 24 hours in majority of the hospitals in the N. H s. So we may end up still doing some delayed lab colleagues after all, thank you very much.