Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (C-GALL trial): pragmatic, multicentre randomised controlled trial
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SUBMITTER: Ahmed I
PROVIDER: S-EPMC10698555 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundGallstone disease (cholelithiasis) is common. In most people it is asymptomatic and does not require treatment, but in about 20% it can become symptomatic, causing pain and other complications requiring medical attention and/or surgery. A proportion of symptomatic people with uncomplicated gallstone disease do not experience further episodes of pain and, therefore, could be treated conservatively. Moreover, surgery carries risks of perioperative and postoperative complications.Methods and analysisC-Gall is a pragmatic, multicentre, randomised controlled trial and economic evaluation to assess whether cholecystectomy is cost-effective compared with observation/ conservative management (here after referred to as medical management) at 18 months post-randomisation (with internal pilot).Primary outcome measurePatient-reported quality of life (QoL) (36-Item Short Form Survey (SF-36) bodily pain domain) up to 18 months after randomisation.The primary economic outcome is incremental cost per quality-adjusted life year gained at 18 months.Secondary outcome measuresSecondary outcome measures include condition-specific QoL, SF-36 domains, complications, further treatment, persistent symptoms, healthcare resource use, and costs assessed at 18 and 24 months after randomisation. The bodily pain domain of the SF-36 will also be assessed at 24 months after randomisation.A sample size of 430 participants was calculated. Computer-generated 1:1 randomisation was used.The C-Gall Study is currently in follow-up in 20 UK research centres. The first patient was randomised on 1 August 2016, with follow-up to be completed by 30 November 2021.Statistical analysisStatistical analysis of the primary outcome will be intention-to-treat and a per-protocol analysis. The primary outcome, area under the curve (AUC) for the SF-36 bodily pain up to 18 months, will be generated using the Trapezium rule and analysed using linear regression with adjustment for the minimisation variables (recruitment site, sex and age). For the secondary outcome, SF-36 bodily pain, AUC up to 24 months will be analysed in a similar way. Other secondary outcomes will be analysed using generalised linear models with adjustment for minimisation and baseline variables, as appropriate. Statistical significance will be at the two-sided 5% level with corresponding CIs.Ethics and disseminationThe North of Scotland Research Ethics Committee approved this study (16/NS/0053). The dissemination plans include Health Technology Assessment monograph, international scientific meetings and publications in high-impact, open-access journals.Trial registration numberISRCTN55215960; pre-results.
| S-EPMC7996370 | biostudies-literature
Project description:BackgroundHeterogeneity of outcomes is a problem for assessing intervention effectiveness when considering treatments for uncomplicated symptomatic gallstone disease. The value to all stakeholders of outcomes that have been measured and reported to date is also unclear. The aim of this study was to develop a core outcome set for symptomatic uncomplicated gallstone disease.MethodsAn in person-meeting was held with patients to prioritize potentially important outcomes from a previously developed longlist of outcomes. This was followed by an online three-round Delphi survey that was conducted with healthcare professionals. The results of each consensus process were compared and combined to produce the final core outcome set.ResultsA total of 82 participants enrolled in round 1 of the Delphi survey, with a final sample of 40 participants contributing to round 3. Five patients contributed to the in-person group meeting. Following the consensus processes, 11 outcomes were considered to be core by patients and healthcare professionals, and included in the core outcome set. These were: quality of life; overall health state; overall satisfaction; overall pain; common bile duct injury; biliary leak; haemorrhage; need for endoscopic retrograde cholangiopancreatography; intra-abdominal collections; admission/readmission for problems; and reoperation.ConclusionA core outcome set for symptomatic uncomplicated gallstone disease has been developed with patients and healthcare professionals. Eleven outcomes across four key domains have been identified. These represent the minimum set of outcomes that should be reported in trials evaluating interventions for gallstone disease.
| S-EPMC10364745 | biostudies-literature
Project description:IntroductionAgenesis of gallbladder is a rare congenital anomaly of biliary tree that may be associated with other biliary and extra biliary congenital anomalies.Case presentationA 43- year- old female presented with a 4 months history of upper abdominal pain associated with nausea and vomiting. It was associated with dyspeptic symptoms and become worse following ingestion of high-fat meal contents. Clinically, a differential of gall stone disease was considered. Ultrasonography of abdomen revealed a contracted gallbladder with multiple stones with normal wall thickness, so the fact of clinical diagnosis considering finding cholithiasis. She was submitted to laparoscopic exploration which revealed that the gall bladder was absent within gall bladder fossa.DiscussionIn this case, the differential of cholithiasis symptoms considered support by ultrasonography, symptomatic gall stones presented more than half of cases of gall bladder agenesis, Diagnosis of gall bladder disease usually done by ultrasound modality, it must be done by expert one. Awareness of this entity by clinicians, surgeons and radiologists are essential because many of these patients present with biliary symptoms and have unnecessary operations.ConclusionAgenesis of gallbladder should be kept in mind whenever the gall bladder was improperly visualized in routine imaging methods. Ultrasonography operated dependent we must not depend on single one or even multiple done by the same person. Avoid a needless surgical exploration, which might be risky. Non-visualized gall bladder during laparoscopic cholecystectomy is challenging should not convert to open unless sure that the gall bladder was present.
| S-EPMC5552385 | biostudies-literature
Project description:BackgroundThe Gallstone Pancreatitis: Admission vs Normal Cholecystectomy (Gallstone PANC) Trial demonstrated that cholecystectomy within 24 hours of admission (early) compared with after clinical resolution (control) for mild gallstone pancreatitis, significantly reduced 30-day length-of-stay (LOS) without increasing major postoperative complications. We assessed whether early cholecystectomy decreased 90-day healthcare use and costs.Study designA secondary economic evaluation of the Gallstone PANC Trial was performed from the healthcare system perspective. Costs for index admissions and all gallstone pancreatitis-related care 90 days post-discharge were obtained from the hospital accounting system and inflated to 2020 USD. Negative binomial regression models and generalized linear models with log-link and gamma distribution, adjusting for randomization strata, were used. Bayesian analysis with neutral prior was used to estimate the probability of cost reduction with early cholecystectomy.ResultsOf 98 randomized patients, 97 were included in the analyses. Baseline characteristics were similar in early (n = 49) and control (n = 48) groups. Early cholecystectomy resulted in a mean absolute difference in LOS of -0.96 days (95% CI, -1.91 to 0.00, p = 0.05). Ninety-day mean total costs were $14,974 (early) vs $16,190 (control) (cost ratio [CR], 0.92; 95% CI, 0.73-1.15, p = 0.47), with a mean absolute difference of $1,216 less (95% CI, -$4,782 to $2,349, p = 0.50) per patient in the early group. On Bayesian analysis, there was an 81% posterior probability that early cholecystectomy reduced 90-day total costs.ConclusionIn this single-center trial, early cholecystectomy for mild gallstone pancreatitis reduced 90-day LOS and had an 81% probability of reducing 90-day healthcare system costs.
| S-EPMC8856738 | biostudies-literature
Project description:Introduction and importanceLeft-sided gall bladder, a rare biliary abnormality with an incidence of 0.04-0.3%, is characterized by the presence of the gall bladder to the left of the ligamentum teres. However, they are often missed during pre-operative imaging and often encountered intraoperatively, thus challenging the surgical intervention for the surgeons.Case presentationWe herein present a 40-year-old male presented with colicky right hypochondriac pain and epigastric discomfort, diagnosed incidentally during laparoscopic cholecystectomy as a left-sided sided gall bladder without situs inversus, which was missed during pre-operative ultrasonography and was treated without any complications with conventional four-port technique without changes in the trocar placement.Clinical discussionGall bladder is normally found in the gall bladder fossa to the right of the ligamentum teres in the plane of the von Rex-Cantlie line; however, left-sided gall bladder is found to the left of the ligamentum teres and is frequently associated with inversus of the abdominal structures and associated vessels. They are frequently overlooked during preoperative diagnostic imaging, ultrasound for colicky discomfort, and encountered during intraoperative operations, confounding the treating surgeon's anatomic expertise. Intra-operative cholangiography is sometimes used as an adjunct, and operations can be accomplished with or without modifications in trocar position.ConclusionDespite preoperative imaging, biliary abnormalities can be discovered accidently during laparoscopic cholecystectomy. Thus, diligent recognition of structures and related anomalies by the treating surgeon has a high value in the best possible outcome for the patient, and left-sided gall bladder can be done with minimum difficulty even without interposition of trocar placement.
| S-EPMC9486847 | biostudies-literature
Project description:Situs inversus is a condition in which the anatomical viscera are placed in a reverse anatomical location, it may be partial affecting the thoracic organs or the abdominal organs, or total affecting both. A 28-year-old man who was a known case of situs inversus totalis presented with epigastric pain and left hypochondrial pain. ultrasound revealed multiple gall stones in a left-sided gall bladder, laparoscopic cholecystectomy was done successfully for him with no complications. Patient position during surgery and the sites of the laparoscopic ports greatly affect the performance during surgery. Identification of the anatomical structures which are arranged in a mirror image pattern is the key for successful surgery. The critical view of safety should be identified before any structure is clipped or divided. A right-handed surgeon will feel more impairment during surgery for a left-sided gall bladder, while a left-handed surgeon will do it with better comfort. Surgeries for such cases are better to be performed by a surgeon with massive experience in laparoscopy or by a hepatobiliary surgeon, it may not be suitable for surgeons in training. MRCP will show the biliary anatomy prior to surgery and CT-scan with dual phase contrast will help to show any associated vascular abnormalities.
| S-EPMC6804321 | biostudies-literature
Project description:BackgroundIntraoperative laparoscopic ultrasonography (LUS) or intraoperative cholangiography (IOC) can be used for visualisation of the biliary tract during laparoscopic cholecystectomy. The aim of this systematic review was to compare use of LUS with IOC.MethodsPubMed, Embase, the Cochrane Library, and Web of Science were searched (last update: April 2024). PICO: P = patients undergoing intraoperative imaging of the biliary tree during laparoscopic cholecystectomy for gallstone disease; I = intervention: LUS; C = comparison: IOC; O = outcomes: mortality, bile duct injury, retained gallstone, conversion to open cholecystectomy, procedural failure, operation time including imaging time. Included articles were critically appraised using checklists. Conclusions were based on studies without major risk of bias. Meta-analyses were performed using random effects models. Certainty of evidence was assessed according to GRADE.ResultsSixteen non-randomised studies met the PICO. Two before/after studies (594 versus 807 patients) contributed to conclusions regarding mortality (no events; very low certainty evidence), bile duct injury (1 versus 0 events; very low certainty evidence), retained gallstone (2 versus 2 events; very low certainty evidence), and conversion to open cholecystectomy (6 versus 21 events; risk ratio: 0.38 (95% confidence interval: 0.15-0.95); I2 = 0%; low certainty evidence). Seven additional studies, using intra-individual comparisons, contributed to conclusions regarding procedural failure; risk ratio: 1.12 (95% confidence interval: 0.70-1.78; I2 = 83%; very low certainty evidence). No studies reported operation time. Mean imaging time for LUS and IOC, reported in 12 studies, was 4.8‒10.2 versus 10.9‒17.9 min (mean difference: - 7.8 min (95% confidence interval: - 9.3 to - 6.3); I2 = 95%; moderate certainty evidence).ConclusionIt is uncertain whether there is any difference in mortality/bile duct injury/retained gallstone using LUS compared with IOC, but LUS may be associated with fewer conversions to open cholecystectomy and is probably associated with shorter imaging time.
| S-EPMC11362195 | biostudies-literature
Project description:ObjectiveTo assess whether laparoscopic cholecystectomy is superior to percutaneous catheter drainage in high risk patients with acute calculous cholecystitis.DesignMulticentre, randomised controlled, superiority trial.Setting11 hospitals in the Netherlands, February 2011 to January 2016.Participants142 high risk patients with acute calculous cholecystitis were randomly allocated to laparoscopic cholecystectomy (n=66) or to percutaneous catheter drainage (n=68). High risk was defined as an acute physiological assessment and chronic health evaluation II (APACHE II) score of 7 or more.Main outcome measuresThe primary endpoints were death within one year and the occurrence of major complications, defined as infectious and cardiopulmonary complications within one month, need for reintervention (surgical, radiological, or endoscopic that had to be related to acute cholecystitis) within one year, or recurrent biliary disease within one year.ResultsThe trial was concluded early after a planned interim analysis. The rate of death did not differ between the laparoscopic cholecystectomy and percutaneous catheter drainage group (3% v 9%, P=0.27), but major complications occurred in eight of 66 patients (12%) assigned to cholecystectomy and in 44 of 68 patients (65%) assigned to percutaneous drainage (risk ratio 0.19, 95% confidence interval 0.10 to 0.37; P<0.001). In the drainage group 45 patients (66%) required a reintervention compared with eight patients (12%) in the cholecystectomy group (P<0.001). Recurrent biliary disease occurred more often in the percutaneous drainage group (53% v 5%, P<0.001), and the median length of hospital stay was longer (9 days v 5 days, P<0.001).ConclusionLaparoscopic cholecystectomy compared with percutaneous catheter drainage reduced the rate of major complications in high risk patients with acute cholecystitis.Trial registrationDutch Trial Register NTR2666.
| S-EPMC6174331 | biostudies-literature
Project description:A 15-year-old girl presented with gallstone pancreatitis. Subsequently, a pseudopancreatic cyst developed that was diagnosed on computed tomographic scan. She underwent a laparoscopic and gastroscopic transgastric cystogastrostomy. In the following report, we describe our novel approach and technique for the above condition.
| S-EPMC4335947 | biostudies-other
Project description:BackgroundRecent meta-analyses concluded that antibiotic prophylaxis is not warranted in low-risk laparoscopic cholecystectomy. However, most trials in the meta-analyses had a relatively small sample size and were statistically underpowered. In addition, many of the trials mentioned potential cost savings owing to the elimination of prophylactic antibiotics. However, no trial has statistically estimated the cost effectiveness. To evaluate the results of meta-analyses, we conducted a randomized controlled trial on the role of prophylactic antibiotics in low-risk laparoscopic cholecystectomy with an adequate sample size.MethodsFrom March 2007 to May 2013, at the Department of Surgery, Kansai Medical University, patients who were scheduled for elective laparoscopic cholecystectomy were randomly assigned to one of two arms: those who were and were not administered prophylactic antibiotics. The primary endpoint was the occurrence of postoperative infections and secondary endpoints were postoperative hospital stay and medical costs.FindingsDuring the study period, 518 patients were assigned to the Antibiotics group and 519 to the No antibiotics group. Occurrences of surgical site infections, distant infections and overall infections were significantly lower in the Antibiotics group than in the No antibiotics group (0.8 vs. 3.7%, p = 0.001, OR: 0.205 (95%CI: 0.069 to 0.606); 0.4 vs. 3.1%, p = 0.0004, OR: 0.122 (95%CI: 0.028 to 0.533); 1.2 vs. 6.7%; p<0.0001, OR: 0.162 (95%CI: 0.068 to 0.389), respectively). The postoperative hospital stay was significantly shorter in the Antibiotics group (mean, SD: 3.69±1.56 vs. 4.07±3.00; p = 0.01) and the postoperative medical costs were significantly lower in the Antibiotics group (mean, SD: $766±341 vs. 832±670; p = 0.047). Multivariable analysis showed that independent risk factors for postoperative infectious complications were no prophylactic antibiotics (p<0.0001) and age 65 or older (p = 0.006).ConclusionsPerioperative administration of prophylactic antibiotics should be recommended in laparoscopic cholecystectomy to prevent postoperative infectious complications and to reduce medical costs.Trial registrationUMIN Clinical Trials Registry UMIN000003749.
| S-EPMC4156368 | biostudies-literature