Calcium Citrate Versus Calcium Carbonate in the Management of Chronic Hypoparathyroidism: A Randomized,Double-Blind,Crossover Clinical Trial

In hypoparathyroidism (HypoPT), calcium supplementation is virtually always required, although the disease is likely to be associated with an increased risk of nephrolithiasis. The use of calcium citrate (Ca-Cit) theoretically could have a positive impact on the nephrolithiasis risk because citrate salts are used to reduce this risk. Our objective was to evaluate the potential therapeutic advantage of Ca-Cit in comparison with calcium carbonate (CaCO₃) in HypoPT, on nephrolithiasis risk factors, as well as to their ability to maintain desirable serum calcium levels. We also evaluated these preparations on quality of life (QOL). This randomized, double-blind, crossover trial recruited 24 adults with postsurgical chronic hypoparathyroidism at Campus Bio-Medico University of Rome. Participants were randomized 1:1 to Ca-Cit or CaCO₃ for 1 month and then crossed over to the other treatment for another month. The primary outcomes were changes in albumin-adjusted serum calcium and in ion activity product of calcium oxalate levels (AP[CaOx] index). Secondary efficacy outcomes included changes in SF-36 survey score, fatigue score, constipation, and adverse events. No difference in terms of AP(CaOx) index was observed between the two groups. However, Ca-Cit was associated with a significant reduction in the oxalate/creatinine ratio compared with CaCO₃ (−2.46 mmol/mol [SD 11.93] versus 7.42 mmol/mol [SD 17.63], p = 0.029). Serum calcium and phosphorus concentration was not different between the two calcium preparations. Ca-Cit was associated with less constipation (p = 0.047). No difference was found in QOL scores. Although Ca-Cit did not modify the AP(CaOx) index when compared with CaCO_3, it was associated with a reduction in urinary oxalate excretion that could have a potential beneficial effect on nephrolithiasis risk. These results are likely to have clinical implications in HypoPT, particularly those who do not tolerate CaCO₃ and those affected by nephrolithiasis. A longer-term experience is needed to confirm these findings. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).     

The Role of Revascularization of the Profunda Femoris Artery in Vasculogenic Impotence

Introduction

Erectile dysfunction is a common disorder, but the underlying cause is difficult to clarify because the organic (endocrine, neurogenic, vasculogenic and iatrogenic) and psychological components are mixed. Vasculogenic impotence, due to penile vascular insufficiency, is a common symptom in patients with aortoiliac occlusive disease (Leriche’s syndrome).The aim of this clinical study was to investigate the hypothesis that revascularization of the profunda femoris artery in Leriche’s syndrome offers good results in vasculogenic erectile dysfunction.

Material and Methods

We investigated 22 men aged 50–65 years (mean 57.5 years) with vasculogenic impotence due to Leriche’s syndrome. Exclusion criteria were: age >70 years, comorbidities, such as diabetes mellitus (DM), heart failure, HIV, history of perineal trauma and medication associated with erectile dysfunction (i.e., antidepressants, anxiolytics, antiandrogenics, anticholinergics). After clinical examination, measurement was made of the angle brachial pressure index (ABPI) and the penis brachial pressure index (PBPI) with duplex ultrasonography (U/S). All the patients underwent vascular imaging: 15 digital subtraction angiography (DSA) and 7 computed tomography angiography (CTA). Psychological investigation was carried out and the papaverine test was performed to exclude other causes of impotence. The patients underwent aorto-bifemoral bypass, with profundoplasty, if needed, and were followed for one year after operation with clinical examination and measurement of the ABPI and PBPI with duplex U/S.

esults

Preoperatively, all the patients reported absence of erectile function, with inability to achieve an erection of sufficient rigidity. Clinical examination revealed absence of pulses to peripheral arteries beyond the femoral arteries and absence of bruits in the iliac arteries. The ABPI ranged between 0.35 and 0.45 (normal: 1) and the PBPI between 0.2 and 0.32 (normal: 0.75). Aorto-bifemoral reconstruction (Y-Graft) with profundoplasty, if required, was performed on all patients. In 4 patients (group I) the peripheral arteries (common, profunda and superficial femoral artery) were not affected by atherosclerotic disease and profundoplasty was not required. In 18 patients (group II) profundoplasty was necessary because of atherosclerotic occlusion of the superficial femoral arteries and stenosis of the profunda artery.Postoperatively, in group I the ABPI became normal and the PBPI ranged between 0.5 and 0.6. In group II the ABPI ranged between 0.6 and 0.75 and the PBPI between 0.48 and 0.55. During the first month of the postoperative period 14 patients (4 from group I and 10 from group II) had normal erectile function (63.6 %) and during the late postoperative period (3-6 months of follow up) 5 more patients (2 from group I and 3 from group II) had improvement of the erectile function (22.7 %). No significant clinical improvement was observed in the other 3 patients (13.6 %).

Conclusion

In patients with Leriche’s syndrome, revascularization of the profunda femoris artery (profundoplasty) ameliorates vasculogenic impotence through the improvement of the pelvic blood flow via the collateral circulation.

     

Antichemical Protective Gear Prolongs Time to Successful Airway Management: A Randomized, Crossover Study in Humans

Background: Airway management is the first step in resuscitation. The extraordinary conditions in mass casualty situations impose special difficulties in airway management, even for experienced caregivers. The authors evaluated whether wearing surgical attire or antichemical protective gear made any difference in anesthetists' success of airway control with either an endotracheal tube or a laryngeal mask airway.

Methods: Fifteen anesthetists with 2-5 yr of residency and wearing either full antichemical protective gear or surgical attire intubated or inserted laryngeal masks in 60 anesthetized patients. The study was performed in a prospective, randomized, crossover manner. The duration of intubation/insertion was measured from the time the device was grasped to the time a normal capnography recording was obtained.

Results: Endotracheal tubes were introduced significantly (P < 0.01) faster when the anesthetist wore surgical attire (31 +/- 7 vs. 54 +/- 24 s for protective gear), but the mean times necessary to successfully insert laryngeal masks were similar (44 +/- 20 s for surgical attire vs. 39 +/- 11 s for protective gear). Neither performance failure nor incidences of hypoxemia were recorded.     

Filling Hemodialysis Catheters in the Interdialytic Period: Heparin Versus Citrate Versus Polygeline: A Prospective Randomized Study

Heparin and saline are commonly used to fill hemodialysis central venous catheters to prevent their thrombosis during the interdialytic period. The purpose of this prospective clinical study was to evaluate whether replacing heparin with citrate or polygeline could ensure satisfactory catheter function without exposing patients to the risk of systemic heparinization. Thirty end-stage renal disease (ESRD) patients with subclavian or jugular single lumen catheters as temporary vascular access for hemodialysis were enrolled. After the insertion of the catheters, the patients were randomly assigned to one of the following three filling groups: Group A, heparin; Group B, citrate; Group C, polygeline. Before each dialysis, the filling solution was aspirated and clot volume, if present, was measured. The catheter usage time and the clot volume were 23 ± 24 days and 0.052 ± 0.035 ml in Group A, 51 ± 36 days and 0.059 ± 0.032 ml in Group B, and 32 ± 10 days and 0.056 ± 0.038 ml in Group C, respectively. Our results indicate that citrate or polygeline can replace heparin effectively as a filling solution for single lumen temporary hemodialysis catheters.     

Pulsed-dye Laser Versus Intralesional Steroid in the Management of Nail Psoriasis: A Randomized,Intra-patient,Comparative, Controlled Study

BackgroundIntralesional injection of corticosteroid (ILIS) and pulsed-dye laser (PDL) have been used in nail psoriasis treatment with variable outcomes.ObjectiveWe sought to compare the efficacy of ILIS to PDL for the treatment of psoriatic fingernails using a dermoscope in the assessment and follow-up.MethodsThis study included 30 patients with bilateral nail psoriasis. The fingernails of one hand were treated with PDL, whereas ILIS was used to treat the fingernails of the other hand. One psoriatic nail was left alone as a control. Every patient received four treatment sessions once every month. Efficacy was recorded clinically using the Nail Psoriasis Severity Index (NAPSI) and by a dermoscope before treatment (baseline) and at eight, 24, and 36 weeks after treatment.ResultsThe assessment by NAPSI revealed improvements of 22.24% and 24.11% occurred in the laser group and the intralesional steroid group, respectively. Also, the dermoscopic assessments revealed an improvement of 18.33% in the laser group versus that of 21.69% in the ILES. No significant difference was found between the two groups.ConclusionBoth PDL and ILIS are considered safe treatments for nail psoriasis, yielding nearly equal results. The dermoscope is a reliable tool for the diagnosis and follow-up of nail psoriasis treatment.     

A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients

Pharmacokinetic analyses comparing generic tacrolimus preparations versus the reference drug in kidney transplant patients are lacking. A prospective, multicenter, open‐label, randomized, two‐period (14 days per period), two‐sequence, crossover and steady‐state pharmacokinetic study was undertaken to compare twice‐daily generic tacrolimus (Sandoz) versus reference tacrolimus (Prograf®) in stable renal transplant patients. AUC_0–12h and peak concentration (C_max) were calculated from 12 h pharmacokinetic profiles at the end of each period (days 14 and 28). Of 71 patients enrolled, 68 provided evaluable pharmacokinetic data. The ratios of geometric means were 1.02 (90% CI 97–108%, p = 0.486) for AUC_0–12h and 1.09 (90% CI 101–118%, p = 0.057) for C_max. Mean (SD) C₀ was 7.3(1.8) ng/mL for generic tacrolimus versus 7.0(2.1) ng/mL for reference tacrolimus based on data from days 14 and 28. Correlations between 12 h trough levels and AUC were r = 0.917 for generic tacrolimus and r = 0.887 for reference drug at day 28. These data indicate that generic tacrolimus (Sandoz) has a similar pharmacokinetic profile to the reference drug and is bioequivalent in kidney transplant recipients according to US Food and Drug Administration and European Medicines Agency guidelines.     

Early Versus Delayed Shoulder Motion Following Axillary Dissection: A Randomized Prospective Study

The role and timing of physical therapy following axillary dissection for melanoma, or in conjunction with modified radical mastectomy has not been extensively studied. A prospective randomized clinical trial was carried out over an 18-month period in the Surgery Branch, National Cancer Institute (NCI) and Department of Rehabilitation Medicine, Clinical Center, in which patients were assigned to receive one of two postoperative physical therapy regimens. Patients were assigned to receive graduated increases in allowed range of motion (ROM), either beginning on postoperative day 1 (early) or day 7 (delayed). All patients were advanced to full pain-free ROM when the suction catheters were removed. A total of 36 patients with 40 axillary dissections (19 for melanoma, 21 for breast cancer) were included in this study. Patients randomized to receive early motion had more total wound drainage (805 ± 516 cc vs. 420 ± 301 cc, p < 0.01), more days of drainage (10.3 ± 5.3 vs. 6.2 ± 2.7, p < 0.01), and later postoperative day of discharge (12.8 ± 5.1 days vs. 9.2 ± 4.0 days, p < 0.02) than did patients who started motion on day 7. Wound complications including infection and small areas of skin breakdown occurred more frequently in the early group (seven patients vs. one patient, p < 0.02). No significant differences in the per cent of patients achieving functional ROM could be identified between these two groups at one, three or six months after operation. Transient serratus anterior palsy (12 patients) and latissimus dorsi palsy (2 patients) occurred in approximately 30% of all patients, regardless of group (breast vs. melanoma, early vs. delayed), but returned to normal in all patients. The early institution of flexion and abduction exercises following axillary dissection thus appears to have a deleterious effect on wound healing and drainage. Adequate functional ROM is attained in all patients with a minimum of complications when active motion exercises are delayed for up to 7 days after axillary dissection.     

Laparoscopic Cholecystectomy Versus Mini-Laparotomy Cholecystectomy: A Prospective, Randomized, Single-Blind Study

OBJECTIVE: To analyze outcomes after open small-incision surgery (minilaparotomy) and laparoscopic surgery for gallstone disease in general surgical practice. METHODS: This study was a randomized, single-blind, multicenter trial comparing laparoscopic cholecystectomy (LC) to minilaparotomy cholecystectomy (MC). Both elective and acute patients were eligible for inclusion. All surgeons normally performing cholecystectomy, both trainees under supervision and consultants, operated on randomized patients. LC was a routine procedure at participating hospitals, whereas MC was introduced after a short training period. All nonrandomized cholecystectomies at participating units during the study period were also recorded to analyze the external validity of trial results. The randomization period was from March 1, 1997, to April 30, 1999. RESULTS: Of 1,705 cholecystectomies performed at participating units during the randomization period, 724 entered the trial and 362 patients were randomized to each of the procedures. The groups were well matched for age and sex, but there were fewer acute operations in the LC group than the MC group. In the LC group 264 and in the MC group 150 operations were performed by surgeons who had done more than 25 operations of that type. Median operating times were 100 and 85 minutes for LC and MC, respectively. Median hospital stay was 2 days in each group, but in a nonparametric test it was significantly shorter after LC. Median sick leave and time for return to normal recreational activities were shorter after LC than MC. Intraoperative complications were less frequent in the MC group, but there was no difference in the postoperative complication rate between the groups. There was one serious bile duct injury in each group, but no deaths. CONCLUSIONS: Operating time was longer and convalescence was smoother for LC compared with MC. Further analyses of LC versus MC are necessary regarding surgical training, surgical outcome, and health economy.     

Laparoscopy-Assisted Distal Gastrectomy Versus Open Distal Gastrectomy. A Prospective Randomized Single-Blind Study

Background

Laparoscopy-assisted distal gastrectomy (LADG) is generally considered superior to open distal gastrectomy (ODG) with regard to postoperative quality-of-life. Differences in postoperative pain may exist due to recent pain control techniques including epidural anesthesia. There is little evidence for this difference. In this article we report the results of our randomized single-blind study in LADG versus ODG. The aim of the present study was to evaluate differences in postoperative physical activity between LADG and ODG.

Methods

Forty patients with early gastric cancer (stage IA and IB) were registered in this randomized study. For strict evaluation, patients were not told about the type of operation until postoperative day 7. Postoperative physical activity was evaluated objectively by Active Tracer, which records the cumulative acceleration over a 24 h period to investigate differences in postoperative recovery. Questionnaire and visual analog scale score related to postoperative pain were also investigated.

Results

Significant differences were observed with a more favorable outcome noted in the LADG group with respect to intraoperative blood loss (P < 0.001), total amount of pain rescue (P < 0.001), wound size (P < 0.001), postoperative hospital stay (P < 0.001), and inflammatory parameters (C-reactive protein, SaO₂, and duration of febrile period) (P < 0.001). Cumulative physical recovery to 70 % of the preoperative level was significantly shorter (by 3 days, P < 0.001) in the LADG group.

Conclusions

Comparison of LADG and ODG for patients with early gastric cancer showed favorable outcome and earlier recovery of physical activity in the LADG group.