Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial

Dijk, Aafke H. van; Wennmacker, Sarah Z.; Reuver, Philip R. de; Latenstein, Carmen S S; Buyne, Otmar R.; Donkervoort, Sandra; Eijsbouts, Q. A. J.; Heisterkamp, Joos; Hof, Klaas in 't; Janssen, Jan; Nieuwenhuijs, Vincent B.; Schaap, Henk M; Steenvoorde, Pascal; Stockmann, H. B. A. C.; Boerma, Djamila; Westert, Gert P.; Drenth, Joost P.H.; Dijkgraaf, Marcel G. W.; Boermeester, Marja A.; Laarhoven, Cornelius J H M van

doi:10.1016/s0140-6736(19)30941-9

Cited by 51 publications

(65 citation statements)

References 31 publications

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“…The main drawback to this approach may be that the use of more conservative treatment is reduced, particularly in the context of decreasing use of shockwave lithotripsy [15] and evidence over the efficacy of medical expulsion therapy [16]. Parallels can be drawn with similar developments in gallbladder surgery where the initial move to offering immediate surgery [17] has now been tempered with calls to be more restrictive due to a risk of overtreatment [18].…”

Section: Discussionmentioning

confidence: 99%

Comparison of Primary and Delayed Ureteroscopy for Ureteric Stones: A Prospective Non-Randomized Comparative Study

et al. 2020

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Background: Primary ureteroscopy (P-URS) has been shown to be as safe and as efficacious as preoperative stent insertion followed by a delayed ureteroscopy (D-URS). However, studies are of limited patient cohort. Methods: A prospective study comparing P-URS and laser fragmentation for ureteric stones to those who received a stent insertion followed by D-URS and stone fragmentation. Results: A total of 367 consecutive patients were included. P-URS was conducted on 235 patients and D-URS on 132 patients. There was no overall difference between patient or stone demographics between the 2 groups, although there were more proximal ureteric and pelvi-ureteric junction stones in the preoperative stent group. The mean operative times were comparable with a stone free rate of 97 and 94% in the preoperative stent and no-stent groups, respectively. The overall complication rates were comparable. Conclusion: The current study provides evidence for the feasibility, safety, and efficacy of P-URS for ureteric calculi in a publicly funded healthcare setting with results comparable to those patients with a preoperative stent and delayed procedure. Therefore, cumulatively, P-URS could lead to less hospitalization, length of stay, stent-related morbidity, and ultimately will be more cost-effective.

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Section: Discussionmentioning

confidence: 99%

Comparison of Primary and Delayed Ureteroscopy for Ureteric Stones: A Prospective Non-Randomized Comparative Study

et al. 2020

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“…This certainly contributed to more uniformity in decision-making for surgery from the surgeon's perspective. Clinical trials, researching the indication for a cholecystectomy and improving the outcome after cholecystectomy, could also result in less hospital variation [24].…”

Section: Discussionmentioning

confidence: 99%

Hospital Variation in Cholecystectomies in The Netherlands: A Nationwide Observational Study

et al. 2020

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Background: Practice variation generally raises concerns about the quality of care. This study determined the longitudinal degree of hospital variation in proportion of patients with gallstone disease undergoing cholecystectomy, while adjusted for case-mix, and the effect on clinical outcomes. Methods: A nationwide, longitudinal, database study was performed in all hospitals in the Netherlands in 2013-2015. Patients with gallstone disease were collected from the diagnosis-related group database. Hospital variation in casemix-adjusted cholecystectomy rates was calculated per year. Clinical outcomes after cholecystectomy were compared between hospitals in the lowest/highest 20th percentile of the distribution of adjusted cholecystectomy rates in all 3 subsequent years. Results: In total, 96,673 patients with gallstones were included. The cholecystectomy rate was 73.6%. In 2013-2015, the case-mix-adjusted performance of cholecystectomies was in hospitals with high rates 1.5-1.6 times higher than in hospitals with low rates. Hospitals with a high adjusted cholecystectomy rate had a higher laparoscopy rate, shorter time to surgery, and less emergency department visits after a cholecystectomy compared to hospitals with a low-adjusted cholecystectomy rate. Conclusion: Hospital variation in cholecystectomies in the Netherlands is modest, cholecystectomy rates varies by <2-fold, and variation is stable over time. Cholecystectomies in hospitals with high adjusted cholecystectomy rates are associated with improved outcomes.

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“…The lancet writes that adopting restrictive selection criteria for decision making significantly reduces the rates of unnecessary cholecystectomies (68% as compared to 75% in usual care group) than operating merely on surgeon's discretion. 40…”

Section: Need To Adopt Restrictive Criteria For Elective Cholecystectmentioning

confidence: 99%

Need for restrictive criteria to define symptomatic cholelithiasis to avoid unnecessary cholecystectomies-evidence from the literature review

Nabi

2021

Int Surg J

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Gall stone disease (GSD) is one among the most common reasons for which patients flock the office of general surgeons and cholecystectomy is one of the most common surgeries performed worldwide. Though majority of the patients are asymptomatic but a considerable number among them are deprived of their vital gall bladder for just or unjust reasons. With the introduction of laparoscopic cholecystectomy, there has been significant escalation in unnecessary cholecystectomies leading to excessive burden on health care system as well as subjecting patients to undue surgical risk. Considering the benign natural history of GSD, a restrictive strategy should be adopted while deciding surgical management for GSD. In this article, the author has given evidence from already published literature to support his views. Preoperative and sincere assessment of each symptom with exclusion of functional disorders and due consideration of patient’s life expectancy are paramount in reducing unnecessary cholecystectomies as well as ensuring long tern relief of symptoms post-surgery.

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Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial

Cited by 51 publications

References 31 publications

Comparison of Primary and Delayed Ureteroscopy for Ureteric Stones: A Prospective Non-Randomized Comparative Study

Comparison of Primary and Delayed Ureteroscopy for Ureteric Stones: A Prospective Non-Randomized Comparative Study

Hospital Variation in Cholecystectomies in The Netherlands: A Nationwide Observational Study

Need for restrictive criteria to define symptomatic cholelithiasis to avoid unnecessary cholecystectomies-evidence from the literature review

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