Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones: 5-Year Follow-Up of the SECURE Randomized Clinical Trial.

Importance: The 1-year results of the SECURE trial, a randomized trial comparing a restrictive strategy vs usual care for select patients with symptomatic cholelithiasis for cholecystectomy, resulted in a significantly lower operation rate after restrictive strategy. However, a restrictive strategy did not result in more pain-free patients at 1 year. Objective: To gauge pain level and determine the proportion of pain-free patients, operation rate, and biliary and surgical complications at the 5-year follow-up. Design, Setting, and Participants: This randomized clinical trial was a multicenter, parallel-arm, noninferiority, prospective study. Between February 2014 and April 2017, patients from 24 hospitals with symptomatic, uncomplicated cholelithiasis were included. Uncomplicated cholelithiasis was defined as gallstone disease without signs of complicated cholelithiasis, ie, biliary pancreatitis, cholangitis, common bile duct stones, or cholecystitis. Follow-up data for this analysis were collected by telephone from July 11, 2019, to September 23, 2023. Interventions: Patients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy. Main Outcomes and Measures: The primary, noninferiority end point was proportion of patients who were pain free as evaluated by Izbicki pain score at the 5-year follow-up. A 5% noninferiority margin was chosen. The secondary end points included cholecystectomy rates, biliary and surgical complications, and patient satisfaction. Results: Among 1067 patients, the median (IQR) age was 49.0 years (38.0-59.0 years); 786 (73.7%) were female, and 281 (26.3%) were male. At the 5-year follow-up, 228 of 363 patients (62.8%) were pain free in the usual care group, compared with 216 of 353 patients (61.2%) in restrictive strategy group (difference, 1.6%; 1-sided 95% lower confidence limit, -7.6%; noninferiority P = .18). After cholecystectomy, 187 of 294 patients (63.6%) in the usual care group and 160 of 254 patients (63.0%) in the restrictive strategy group were pain free, respectively (P = .88). The restrictive care strategy was associated with 387 of 529 cholecystectomies (73.2%) compared with 437 of 536 in the usual care group (81.5%; 8.3% difference; P = .001). No differences between groups were observed in biliary and surgical complications or in patient satisfaction. Conclusions and Relevance: In the long-term, a restrictive strategy results in a significant but small reduction in operation rate compared with usual care and is not associated with increased biliary and surgical complications. However, regardless of the strategy, only two-third of patients were pain free. Further criteria for selecting patients with uncomplicated cholelithiasis for cholecystectomy and rethinking laparoscopic cholecystectomy as treatment is needed to improve patient-reported outcomes. Trial Registration: CCMO Identifier: NTR4022.

Oncological Safety and Potential Cost Savings of Routine vs Selective Histopathological Examination After Appendectomy: Results of the Multicenter, Prospective, Cross-Sectional FANCY Study.

OBJECTIVE: To investigate the oncological safety and potential cost savings of selective histopathological examination after appendectomy. BACKGROUND: The necessity of routine histopathological examination after appendectomy has been questioned, but prospective studies investigating the safety of a selective policy are lacking. METHODS: In this multicenter, prospective, cross-sectional study, inspection and palpation of the (meso)appendix was performed by the surgeon in patients with suspected appendicitis. The surgeon's opinion on additional value of histopathological examination was reported before sending all specimens to the pathologist. Main outcomes were the number of hypothetically missed appendiceal neoplasms with clinical consequences benefiting the patient (upper limit two-sided 95% confidence interval below 3:1000 considered oncologically safe) and potential cost savings after selective histopathological examination. RESULTS: Seven thousand three hundred thirty-nine patients were included. After a selective policy, 4966/7339 (67.7%) specimens would have been refrained from histopathological examination. Appendiceal neoplasms with clinical consequences would have been missed in 22/4966 patients. In 5/22, residual disease was completely resected during additional surgery. Hence, an appendiceal neoplasm with clinical consequences benefiting the patient would have been missed in 1.01:1000 patients (upper limit 95% confidence interval 1.61:1000). In contrast, twice as many patients (10/22) would not have been exposed to potential harm due to re-resections without clear benefit, whereas consequences were neither beneficial nor harmful in the remaining seven. Estimated cost savings established by replacing routine for selective histopathological examination were €725,400 per 10,000 patients. CONCLUSIONS: Selective histopathological examination after appendectomy for suspected appendicitis is oncologically safe and will likely result in a reduction of pathologists' workload, less costs, and fewer re-resections without clear benefit.

Safety and economic analysis of selective histopathology following cholecystectomy: multicentre, prospective, cross-sectional FANCY study.

BACKGROUND: There is ongoing debate concerning the necessity of routine histopathological examination following cholecystectomy. In order to reduce the pathology workload and save costs, a selective approach has been suggested, but evidence regarding its oncological safety is lacking. METHODS: In this multicentre, prospective, cross-sectional study, all gallbladders removed for gallstone disease or cholecystitis were systematically examined by the surgeon for macroscopic abnormalities indicative of malignancy. Before sending all specimens to the pathologist, the surgeon judged whether histopathological examination was indicated. The main outcomes were the number of patients with hypothetically missed malignancy with clinical consequences (upper limit two-sided 95 per cent c.i. below 3:1000 considered oncologically safe) and potential cost savings of selective histopathological examination. RESULTS: Twenty-two (2.19:1000) of 10 041 specimens exhibited malignancy with clinical consequences. In case of a selective policy, surgeons would have held back 7846 of 10041 (78.1 per cent) gallbladders from histopathological examination. Malignancy with clinical consequences would have been missed in seven of 7846 patients (0.89:1000, upper limit 95% c.i. 1.40:1000). No patient benefitted from the clinical consequences, while two were harmed (futile additional surgery). Of 15 patients in whom malignancy with clinical consequences would have been diagnosed, one benefitted (residual disease radically removed), two potentially benefitted (palliative systemic therapy), and four experienced harm (futile additional surgery). Estimated cost savings established by replacing routine for selective histopathological examination were €703 500 per 10 000 patients. CONCLUSION: Selective histopathological examination following cholecystectomy is oncologically safe and could reduce pathology workload, costs, and futile re-resections.

Safety and cost analysis of selective histopathological examination following appendicectomy and cholecystectomy (FANCY study): protocol and statistical analysis plan of a prospective observational multicentre study.

INTRODUCTION: Routine histopathological examination following appendicectomy and cholecystectomy has significant financial implications and comprises a substantial portion of the pathologists' workload, while the incidence of unexpected pathology is low. The aim of the selective histopathological examination Following AppeNdicectomy and CholecystectomY (FANCY) study is to investigate the oncological safety and potential cost savings of selective histopathological examination based on macroscopic assessment performed by the surgeon. METHODS AND ANALYSIS: This is a Dutch multicentre prospective observational study, in which removed appendices and gallbladders will be systematically assessed by the operating surgeon for macroscopic abnormalities suspicious for malignant neoplasms. After visual inspection and digital palpation of the removed specimen, the operating surgeon will report whether macroscopic abnormalities suspicious for a malignant neoplasm are present, and if he or she believes additional microscopic examination by the pathologist is indicated. Regardless of the surgeon's assessment, all specimens will be sent for histopathological examination. In this way, routine histopathological examination can be compared with a hypothetical situation in which specimens are routinely examined by surgeons and only sent to the pathologist on indication. The two main outcomes are oncological safety and potential cost savings of a selective policy. Oncological safety of selective histopathological examination will be assessed by calculating the number of patients in whom a histopathological diagnosis of an appendiceal neoplasm or gallbladder cancer with clinical consequences benefitting the patient would have been missed. A cost analysis will be performed to quantify the potential cost savings. ETHICS AND DISSEMINATION: The study protocol was reviewed by the Institutional Review Board of the Amsterdam UMC, location AMC, which decided that the Dutch Medical Research Involving Human Subjects Act is not applicable. In all participating centres, approval for execution of the FANCY study has been obtained from the local Institutional Review Board before the start of inclusion of patients. The study results will be disseminated through peer-reviewed publications and conference presentations. Guidelines will be revised according to the findings of the study. TRIAL REGISTRATION NUMBER: NCT03510923.

Outcome of initially nonoperative treatment for acute simple appendicitis in children.

PURPOSE: To compare the outcome of initially nonoperative treatment with immediate appendectomy for simple appendicitis in children. METHODS: Between September 2012 and June 2014 children aged 7-17 years with a radiologically confirmed simple appendicitis were invited to participate in a multicentre prospective cohort study in which they were treated with an initially nonoperative treatment strategy; nonparticipants underwent immediate appendectomy. In October 2015, their rates of complications and subsequent appendectomies, and health-related quality of life (HRQOL) were assessed. RESULTS: In this period, 25 children were treated with an initially nonoperative treatment strategy and 19 with immediate appendectomy; median (range) follow-up was 25 (16-36) and 26 (17-34) months, respectively. The percentage [95%CI] of patients experiencing complications in the initially nonoperative group and the immediate appendectomy group was 12 [4-30]% and 11 [3-31]%, respectively. In total 6/25 children (24%) underwent an appendectomy; none of the 6 patients operated subsequently experienced any postappendectomy complications. Overall, HRQOL in the nonoperative treatment group was similar to that of healthy peers. CONCLUSIONS: Outcome of initially nonoperative treatment for acute simple appendicitis in children is similar to the outcome in those who undergo immediate appendectomy. Initially nonoperative management seems to be able to avoid appendectomy in 3 out of 4 children. LEVEL OF EVIDENCE: 2 (prospective comparative study). This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.

Impact of parathyroidectomy for primary hyperparathyroidism on quality of life: A case-control study using Short Form Health Survey 36.

BACKGROUND: Physical and mental complaints are common in patients with primary hyperparathyroidism (PHPT) and negatively impact quality of life (QOL). Subjective symptoms in current guidelines are not considered an indication for surgery. The purpose of this study was to assess the effect of parathyroidectomy on QOL in patients with PHPT. METHODS: This multicenter case-control study investigated preoperative and postoperative QOL scores in patients operated for PHPT, measured with the Short Form Health Survey-36 (SF-36) questionnaire. Results were compared with patients undergoing a hemithyroidectomy, the control group. RESULTS: Fifty-two patients and 49 controls were included. Patients with PHPT had significantly lower QOL scores preoperatively and improved significantly after successful surgical treatment. Postoperatively, no differences were observed between the 2 groups. CONCLUSION: QOL was significantly lower in patients with untreated PHPT. Surgical treatment was associated with a significant increase in QOL. Decreased QOL should also be considered as an indicator for surgical treatment in patients with PHPT. © 2016 Wiley Periodicals, Inc. Head Neck 38:1213-1220, 2016.

Screw needle cytology of thyroid nodules is associated with a lower non-diagnostic rate compared to fine needle aspiration.

BACKGROUND: Fine needle aspiration (FNA) cytology is the method of choice to exclude malignancy in thyroid nodules. A major limitation of thyroid FNA is the relatively high rate (13-17%) of non-diagnostic samples. The aim of this study is to determine the diagnostic yield of a screw needle compared to the conventional FNA. METHODS: We retrospectively analysed thyroid nodule cytology of all patients that underwent thyroid nodule fine needle or screw needle aspiration between July 2007 and July 2012 in a single academic medical centre. Cytology results were categorized according to the Bethesda classification system. RESULTS: In total, 644 punctures of thyroid nodules from 459 patients were available for analysis. The screw needle was used 531 times, and the conventional fine needle 113 times. The percentage of non-diagnostic cytology was significantly lower in the screw needle samples than in the fine needle samples (3% vs 17%, P<0.001). CONCLUSION: This study shows a significantly better diagnostic performance of the screw needle compared to the conventional fine needle in cytology of thyroid nodules.

Initial antibiotic treatment for acute simple appendicitis in children is safe: Short-term results from a multicenter, prospective cohort study.

BACKGROUND: Initial antibiotic treatment for acute appendicitis has been shown to be safe in adults; so far, not much is known about the safety and efficacy of this treatment in children. The aims of this study were to investigate the feasibility of a randomized controlled trial (RCT) evaluating initial antibiotic treatment for acute appendectomy in children with acute simple appendicitis and to evaluate the safety of this approach. METHODS: In a multicenter, prospective cohort study patients aged 7-17 years with a radiologically confirmed simple appendicitis were eligible. Intravenous antibiotics (amoxicillin/clavulanic acid 250/25 mg/kg 4 times daily; maximum 6,000/600 mg/d and gentamicin 7 mg/kg once daily) were administered for 48-72 hours. Clinical reevaluation every 6 hours, daily blood samples, and ultrasound follow-up after 48 hours was performed. In case of improvement after 48 hours, oral antibiotics were given for a total of 7 days. At any time, in case of clinical deterioration or non-improvement after 72 hours, an appendectomy could be performed. Follow-up continued until 8 weeks after discharge. Adverse events were defined as major complications of antibiotic treatment, such as allergic reactions, perforated appendicitis, and recurrent appendicitis. RESULTS: Of 44 eligible patients, 25 participated (inclusion rate, 57%; 95% CI, 42%-70%). Delayed appendectomy was performed in 2, and the other 23 were without symptoms at the 8 weeks follow-up. Minor complications occurred in three patients. None of the patients suffered from an adverse event or a recurrent appendicitis. CONCLUSION: Our study shows that an RCT comparing initial antibiotic treatment strategy with urgent appendectomy is feasible in children; the intervention seems to be safe.

[Multinodular goitre: not always harmless]. / Multinodulair struma: niet altijd onschuldig.

Multinodular goitre has a slow and progressive growth. The clinical presentation of patients with multinodular goitre is variable and dependent on size, location and the functional state of the thyroid tissue. The most frequent clinical symptoms are caused by compression and deviation of the trachea and range from dyspnoea to acute asphyxia. Imaging is important to confirm the size of the multinodular goitre. Timing of the treatment can be critical. However, a good treatment guideline is lacking. There are two treatment options: radioactive iodine and surgical resection. The best treatment option and timing of treatment for patients with multinodular goitre should be assessed and decided on an individual basis. In this clinical report we present two patients who had a multinodular goitre with progressive symptoms for years. Patient A, 66 years of age, was successfully treated with radioactive iodine. Patient B, 77 years of age, underwent a total thyroidectomy.

Endostapler or endoloops for securing the appendiceal stump in laparoscopic appendectomy: a retrospective cohort study.

BACKGROUND: Laparoscopic appendectomy is the treatment of choice for appendicitis provided sufficient laparoscopic expertise is available. The endostapler possibly provides an easier and safer closure of the appendiceal stump, but at greater expense. This study aimed to compare two strategies for closure of the appendiceal stump in a large retrospective cohort of patients. METHODS: This study reviewed patients who underwent laparoscopic appendectomy for acute appendicitis in three academic hospitals and two regional hospitals in The Netherlands during the period 1 January 2007 to 30 June 2011. The endostapler was routinely used in two hospitals and selectively used in the remaining three hospitals. Both strategies were compared for complications according to the Clavien-Dindo classification. RESULTS: A total of 1,036 patients were analyzed according to the strategy followed. The 571 patients in the first group were routinely treated with the endostapler. For the 465 patients in the second group, the intentional method of stump closure was with endoloops. The endostapler was used when indicated for 69 of these patients. The patient characteristics did not differ between the two groups. The groups also did not differ significantly in number of intra- and postoperative complications. In both groups, 4.3 % of the patients had complications classified as grade 3 or higher. There were no significant differences in the prevalence of intraabdominal abscesses (3.2 % vs. 4.3) or wound infections (0.4 and 1.5 %). In a multivariate analysis, the chosen strategy for stump closure was not a significant predictor for postoperative complications. CONCLUSION: Routine use of the endostapler showed no clinical advantages over the use of endoloops with selective endostapler closure. The latter strategy is preferable because it is more cost effective.

[Intraoperative neuromonitoring during endocrine surgery]. / Intraoperatieve neuromonitoring bij endocriene chirurgie.

Recurrent laryngeal nerve (RLN) injury is a known complication of thyroid surgery. Patients undergoing reoperations or extensive resections of malignancies carry an increased risk of nerve damage. The gold standard for preventing RLN injury is identification of the RLN. The development of a new technique has enabled intraoperative testing of RLN function. Intraoperative neuromonitoring has an excellent specificity and negative predictive value in which an unchanged positive signal is highly predictive of intact nerve function. This technique facilitates RLN identification in altered anatomy as is found at reoperation and can prevent bilateral vocal cord palsy. Additionally the prognosis of patients with postoperative voice symptoms can be supported by the objective intraoperative measurements.