Economic burden of recurrent Clostridioides difficile infection in adults admitted to Spanish hospitals. A multicentre retrospective observational study.

OBJECTIVE: Clostridioides difficile infection (CDI) is associated with increased hospital stays and mortality and a high likelihood of rehospitalization, leading to increased health resource use and costs. The objective was to estimate the economic burden of recurrent CDI (rCDI). METHODS: Observational, retrospective study carried out in six hospitals. Adults aged ≥18 years with ≥1 confirmed diagnosis (primary or secondary) of rCDI between January 2010 and May 2018 were included. rCDI-related resource use included days of hospital stay (emergency room, ward, isolation and ICU), tests and treatments. For patients with primary diagnosis of rCDI, the complete hospital stay was attributed to rCDI. When diagnosis of rCDI was secondary, hospital stay attributed to rCDI was estimated using 1:1 propensity score matching as the difference in hospital stay compared to controls. Controls were hospitalizations without CDI recorded in the Spanish National Hospital Discharge Database. The cost was calculated by multiplying the natural resource units by the unit cost. Costs (euros) were updated to 2019. RESULTS: We included 282 rCDI episodes (188 as primary diagnosis): 66.31% of patients were aged ≥65 years and 57.80% were female. The mean hospital stay (SD) was 17.18 (23.27) days: 86.17% of rCDI episodes were isolated for a mean (SD) of 10.30 (9.97) days. The total mean cost (95%-CI) per episode was €10,877 (9,499-12,777), of which the hospital stay accounted for 92.56. CONCLUSIONS: There is high cost and resource use associated with rCDI, highlighting the importance of preventing rCDI to the Spanish National Health System.

Cost-effectiveness analysis of pazopanib in second-line treatment of advanced soft tissue sarcoma in Spain.

PURPOSE: To assess the efficiency of pazopanib compared with trabectedin in the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) after chemotherapy failure. METHODS: The progression of STS was modeled using a partitioned survival analysis model. Survival curves for pazopanib and trabectedin were modeled using data from PALETTE phase III clinical trial and based on unadjusted indirect comparison. Effectiveness was measured in quality-adjusted life years (QALY). The Spanish National Health System perspective was considered over a 10-year time horizon, including direct health care costs (, 2014). A discount rate of 3% was applied to both costs and outcomes. The robustness of the results was evaluated using univariate and probabilistic sensitivity analyses (PSA). RESULTS: Pazopanib was associated with better health outcomes than trabectedin (0.705 versus 0.686 QALY). Pazopanib also showed lower direct health care costs (21,861 versus 45,338), mainly due to lower cost of pharmacological treatment (13,762 versus 33,392), administration (57 versus 2,955) and AE management (658 versus 1,695) costs. PSA confirmed that pazopanib was a dominant option in 71% of the simulations performed. CONCLUSIONS: In this analysis, and from a health economics perspective, pazopanib was the option of choice versus trabectedin in the treatment of adult patients with advanced soft-tissue sarcoma after chemotherapy failure.

Quality of life and economic impact of refractory epilepsy in Spain: the ESPERA study.

INTRODUCTION: Despite use of currently available anti-epileptic drugs (AED), 30% of epilepsy patients are not seizure-free. The purpose of this study was to estimate the quality of life and economic impact in Spain of drug-resistant epilepsy (DRE), as defined by the International League Against Epilepsy (ILAE). METHODS: Observational retrospective 12-month study conducted in Spain including adults with focal epilepsy treated with at least two AEDs. Direct costs (€ 2010) were calculated based on health care resources used and their official unit costs. Costs were analysed from the perspectives of the Spanish National Health System (SNS) and society. The impact of DRE on patients' quality of life was examined using the QOLIE 31-P, EQ-5D-3L, and NDDIE questionnaires. RESULTS: We analysed 263 patients out of the 304 recruited. According to ILAE criteria, 70.0% of the patients had drug-resistant epilepsy, while 20.3% achieved seizure freedom. From the viewpoint of the SNS, annual costs for resistant and seizure-free patients were € 4964 and € 2978 respectively (P<.01). Compared to resistant patients, seizure-free patients showed better scores on QOLIE-31P (70.8 vs 56.4, P<.0001) and EQ-5D-3L (75.6 vs 64.7, P<.001). Seizure-free patients showed a lower incidence of major depression compared to resistant patients according to the NDDIE scale (23 vs 8.3%, P<.05). CONCLUSIONS: Results suggest that DRE is associated with increased use of healthcare resources and consequently with higher costs, poorer quality of life and higher incidence of major depression compared to seizure-free patients, thus representing a considerable burden to the SNS and society.

Laparoscopic versus transverse Incision right colectomy for colon carcinoma.

AIM: We investigated whether laparoscopic right colectomy has short-term and / or oncological advantages compared with transverse incision right colectomy. METHOD: Patients who underwent an elective laparoscopic right colectomy or an open right colectomy through a transverse incision at the VU University Medical Center or Zaans Medical Center from 2005 to 2009 were prospectively followed. RESULTS: Patient groups were comparable in terms of gender, body mass index and American Society of Anesthesiology classification. Patients in the transverse incision group were older (68 years vs 75 years, P = 0.07) and blood loss was greater during this procedure (60 ml vs 130 ml, P = 0.001), which cost less than the laparoscopic procedure (€6.033 vs €7.221, P = 0.03). Hospital stay for the laparoscopic group was shorter (8 days vs 9 days, P = 0.04), but laparoscopic procedures took longer (155 min vs 77 min, P < 0.001) and 8% of patients in the laparoscopic group were converted to a median laparotomy. Postoperative complications were comparable for both groups (28% vs 32%, P = 0.74), and in both groups a radical resection rate of 96% (P = 0.94) was achieved. At a median follow up of 20 months the incidence of incisional hernia was similar in both groups and no patient required additional surgery as a result. Overall survival at 60 months was 70% for the laparoscopic group and 67% for the transverse incision group (P = 0.84). CONCLUSION: There a re few clinically relevant differences between a laparoscopic right colectomy and a transverse incision right colectomy. Transverse incision right colectomy is cheaper. The study may be the first to compare these two techniques, but it is a nonrandomized trial and therefore has its limitations.

[Assessment of acute postoperative pain]. / Valoración del dolor agudo postoperatorio.

OBJECTIVE: A nursing task is to look after the pain associated with surgical procedures in order to maintain patient wellbeing. The first objective of this study was to measure the level of the patient satisfaction with management of post-operative pain. Secondly, we wanted to identify the determining factors of an adequate postoperative analgesia and the predictive value of the visual analogical scale (VAS). MATERIAL AND METHODS: A sample of patients who had an operation was interviewed. The VAS was administered two hours and 24h after the surgical procedure with the American Society of Pain questionnaire. ROC curves were applied to establish the cut-off point for the VAS. We determined the contribution of different variables to adequate pain management by means of logistic regression. RESULTS: We interviewed 237 patients in 2007 and 2008. Pain during the first 24h was perceived by 54% of them, 98% were satisfied with pain management and 95% expressed that analgesic treatment relieved their pain. Variables statistically associated with pain were specialty, and a value on the VAS higher than 0 two hours after the procedure. CONCLUSIONS: The management of post operative pain is satisfactory. The use of the VAS during the first two hours identifies an important percentage of patients who require more intensive analgesic treatment.

Severe cardiac allograft dysfunction without endomyocardial biopsy signs of cellular rejection: incidence and management.

Acute dysfunction of cardiac allograft without evidence of cellular rejection is a potentially fatal complication of heart transplantation that suggests a humoral origin. In clinical practice, humoral rejection (HR) is suspected when there is evidence of severe allograft dysfunction but endomyocardial biopsy (EMB) shows no evidence of cellular rejection. Between April 1991 and August 2003, 12 patients (2.74%) among 438 heart transplants displayed this condition. Time post-heart transplant (HT) was 21.3 +/- 24.7 months (range 2 to 72 months). Immunofluorescence studies using classic markers were negative. All patients were treated with methylprednisolone "bolus" and plasmapheresis until clinical recovery, after which their immunosuppressive regimens were modified. Eleven of the 12 patients recovered satisfactory allograft function. In this series the incidence of suspected HR was low. Unlike other studies, we observed HR not only soon but also even years after HT. Plasmapheresis seems to be an effective treatment.

Assessment and classification of fistula-in-ano in patients with Crohn's disease by hydrogen peroxide enhanced transanal ultrasound.

Crohn's disease is well known for its perianal complications, among which fistulas-in-ano are the most common abnormalities. Fistulas-in-ano in Crohn's disease tend to be complex and have a high recurrence rate. Therefore the role of surgery is generally more conservative. Hydrogen peroxide enhanced transanal ultrasound has proven superior to physical examination, fistulography, computed tomography, and conventional ultrasound in demonstrating the fistula tract. This study examined the fistula tracks in patients with Crohn's disease. Forty-one patients with Crohn's disease and fistula-in-ano were investigated using physical examination, sondage of the fistula, proctoscopy and transanal ultrasound. Hydrogen peroxide was infused via a small catheter into the fistula. The main track and the ramification of the fistula were classified according to the anatomical Parks' classification. Only 9 (22%) patients had a single inter- or transsphincteric fistula. In 5 (12%) patients a single supra- or extrasphincteric fistula (high fistula) was found, in 14 (34%) more than one fistula track (ramified), and in 13 (32%) an anovaginal fistula. Thus 78% of patients had a surgically difficult to treat fistula. In the ramified fistula the main track follows the Parks' classification, but ramifications can have a bizarre pattern which is not in agreement with this classification. Optimal documentation by means of hydrogen peroxide enhanced transanal ultrasound is therefore mandatory before surgery or before other therapies such as anti-tumor necrosis factor treatment.

Assessment and classification of never operated and recurrent cryptoglandular fistulas-in-ano using hydrogen peroxide enhanced transanal ultrasound.

OBJECTIVE: Classification and visualization of fistula-in ano is used to determine surgical treatment according to the type of fistula, predict the recurrence rate and incontinence risk and compare the results of treatment published in literature. Hydrogen peroxide enhanced transanal ultrasound (HPUS) with the peroxide introduced through the external opening of the fistula gives a clear and accurate visualization of the track in relation to the sphincters. The aim of this study was to review never operated and recurrent cryptoglandular fistulas-in-ano visualized with the aid of HPUS in order to establish the anatomical differences. PATIENTS AND METHODS: Eighty-one patients with never operated (48) or recurrent (33) cryptoglandular fistulas-in-ano were assessed by clinical examination and HPUS. RESULTS: Never operated fistulas were single track, trans- or inter-sphincteric fistulas in 80%. In 15%, the tracks were sinus with no connection to the pectinate line. Two patients (5%) had a transsphincteric fistula with a ramification. No supra- or extra-sphincteric fistulas were found in the never operated fistula group. In the recurrent fistula patients, 57% had a single trans or intersphincteric track, 15% of the patients had a single track supra or extrasphincteric fistula and 27% had a ramified fistula. CONCLUSIONS: All never operated cryptoglandulair fistulas-in-ano were inter- or trans-sphincteric. An extra track was found in 5%. Recurrent fistulas-in-ano were supra or extrasphincteric in 15% and ramified in 27%. Therefore, never operated fistula-in-ano does not require any special investigation before surgical treatment. However, before treating recurrent fistulas, visualization by HPUS is recommended to detect supra or extrasphincteric fistulas or ramification.

Laparoscopic elective treatment of diverticular disease. A comparison between laparoscopic-assisted and resection-facilitated techniques.

BACKGROUND: Because of the presence of significant inflammatory reaction, elective surgical laparoscopic-assisted treatment of complicated diverticular disease can be difficult, leading to a high conversion and complication rate. Laparoscopic alternatives to this assisted approach consist of the hand-assisted method and the more conventional facilitated laparoscopic sigmoid resection. Facilitated laparoscopic sigmoid resection implies laparoscopic mobilization of the sigmoid as much as possible and splenic flexure when called for. Through a Pfannenstiel incision, the difficult steps of the operation-such as the dissection of the inflammatory process and taking down the fistula, but also resection and manual anastomosis-can be performed. In this study, we compare the operating time, conversion rate, complications, and costs of both assisted and resection-facilitated techniques. METHODS: We compared two consecutive series of 35 patients with diverticular disease who underwent a sigmoid resection by laparoscopy. Both groups were comparable in terms of age, gender, and kind of complicated diverticular disease. RESULTS: The operating time, conversion rate, and costs were all less in the laparoscopic-facilitated group. The fact that there were no conversions in this group is the most important finding of this study. Not only was it possible to convert from the assisted laparoscopic approach to laparotomy (five patients of 35), it was also possible to convert from the assisted to the facilitated form (seven of 35 patients). CONCLUSIONS: Laparoscopic-facilitated sigmoid resection is a feasible intervention for all forms of complicated diverticular disease and yields marked reductions in operating time, conversion rate, and operative and general costs.

Assessment of the biliary tract by ultrasonography and cholangiography during laparoscopic cholecystectomy: a prospective study.

OBJECTIVE: The introduction of laparoscopic cholecystectomy (Lap-chol) has induced routine cholangiography to map the biliary tree and identify common bile duct (CBD) stones. However, the use of more selective criteria for performing intraoperative cholangiography (IOC), drawbacks of IOC and experience with laparoscopic ultrasonography (LU) re-introduced intraoperative ultrasonography for the CBD. The purpose of this study was to compare the accuracy of LU and IOC to identify the anatomy of the CBD and the presence of stones. METHODS: A total of 50 unselected patients undergoing elective laparoscopic cholecystectomy were evaluated by LU and IOC. Stones were found in three patients by IOC and could be confirmed by ultrasonography and CBD exploration in two. RESULTS: Anatomic definition of the biliary tract and success of the procedure was better for LU (90 and 98%) than IOC (86 and 72%). CONCLUSION: For Surgical groups with experience in LU this technique appears to become the standard technique to identify the anatomy of the CBD and assessment of CBD stones.

Hydrogen peroxide-enhanced transanal ultrasound in the assessment of fistula-in-ano.

UNLABELLED: Appropriate classification of the fistulous tracts in patients with fistula-in-ano may be of value for the planning of proper surgery. Conventional transanal ultrasound has limited value in the visualization of fistulous tracts and their internal openings. Hydrogen peroxide can be used as a contrast medium for ultrasound to improve visualization of fistulas. PURPOSE: This prospective study evaluates hydrogen peroxide-enhanced ultrasound in comparison with physical examination, standard ultrasound, and surgery in the assessment of fistula-in-ano. METHODS: Twenty-one consecutive patients (4 women; mean age, 42 years) with fistula-in-ano were evaluated by local physical examination (inspection, probing, and digital examination), conventional ultrasound, and hydrogen peroxide-enhanced ultrasound before surgery. Ultrasound was performed using a B&K Diagnostic Ultrasound System with a 7-MHz rotating endoprobe. Hydrogen peroxide (3%) was infused via a small catheter into the fistula. The results of physical examination, ultrasound, and hydrogen peroxide-enhanced ultrasound were compared with surgical data as the criterion standard. The additive value of standard ultrasound and hydrogen peroxide-enhanced ultrasound compared with physical examination was also determined. RESULTS: At surgery, 8 intersphincteric and 11 transsphincteric fistulas and 2 sinus tracts (without an internal opening) were found. During physical examination, probing was incomplete in 13 patients, the diagnosis being correct in the other 8 patients (38%) as a low (intersphincteric or transsphincteric) fistula. With conventional ultrasound, the assessment of fistula-in-ano was correct in 13 patients (62%); defects in one or both sphincters could also be found (n = 8). With hydrogen peroxide-enhanced ultrasound, the fistulous tract was classified correctly in 20 patients, the overall concordance with surgery being 95%. The internal opening was found at physical examination in 15 patients (71%), with hydrogen peroxide-enhanced ultrasound in 10 patients (48%), and during surgery in 19 patients (90%). Secondary extensions, confirmed during surgery, were found in five cases. In two patients, a secondary extension with hydrogen peroxide-enhanced ultrasound was not confirmed during surgery. Both patients developed a recurrent fistula. CONCLUSION: Hydrogen peroxide-enhanced ultrasound is superior to physical examination and standard ultrasound in delineating the anatomic course of perianal fistulas. It makes accurate preoperative assessment of the fistula possible and may be of value for the surgeon in planning therapeutic strategy.

Vaginal endosonography of the anal sphincter complex is important in the assessment of faecal incontinence and perianal sepsis.

BACKGROUND: Anal endosonography is an established technique in the evaluation of anorectal disease. However, it is sometimes difficult to visualize the anterior part of the sphincter complex and anal endosonography may be impossible when anal pain or stenosis is present. The aim of this study was to evaluate vaginal endosonography in the diagnosis of faecal incontinence and perianal sepsis. METHODS: Anal and vaginal endosonography were performed in 56 women with faecal incontinence (n = 36) or perianal sepsis (n = 20). The technique and pelvic floor anatomy were described, anal sphincter measurements with anal and vaginal endosonography were compared, and the additive value of vaginal over anal endosonography in the diagnosis of faecal incontinence and perianal sepsis was assessed. RESULTS: The pelvic floor was clearly imaged with vaginal endosonography. However, after a relatively short learning curve it was still not possible to image the anal sphincters in three of 28 patients. Except for external anal sphincter thickness, which was significantly lower, all anal canal structure measurements were greater with vaginal than with anal endosonography. Concerning the diagnosis of either faecal incontinence or perianal sepsis, vaginal endosonography added important information in comparison with anal endosonography in 14 (25 per cent) of 56 patients. CONCLUSION: Vaginal endosonography provides reliable images of the anal sphincters in an undistorted fashion, thereby increasing the diagnostic yield of faecal incontinence and perianal sepsis in 25 per cent of patients. Therefore, endosonographists should become acquainted with this technique.

Retroperitoneal sarcomas: pre-operative assessment and surgical therapy.

The clinical and pathological records of 22 patients treated for retroperitoneal sarcomas were retrospectively studied. The initial symptoms were pain and swelling of the abdomen in 11 patients. All tumours had a diameter of more than 10 cm. The pathological diagnosis was in 16 cases liposarcoma or leiomyosarcoma. Fourteen tumours were graded as high and eight as low. Sixteen of the 22 operated patients had complete resection of the tumour. Eleven patients had recurrence after five to 42 months, nine of them local recurrence and two distant metastases. Eleven patients needed repeated radical or palliative resections. Additional therapy (pre- or post-operative radiation or chemotherapy) was given to 11 patients. Radical resection of primary and recurrent tumours seems to give the best results in patients with retroperitoneal sarcomas but debulking of the tumour improves the quality of life in selected patients.

Patterns of psychotropic drug use in a Spanish rural community.

Psychotropic drug use was investigated using a two-stage survey of a random sample of persons aged 17 and over from a rural Spanish community. It was found that 6.9%, 11.8% and 25.1% of the population were consuming psychotropic, analgesic and somatic medicines respectively. Women presented a higher rate of psychotropic use than men (prevalence for women 10.7%, for men 2.6%). This female predominance was found to be significantly related to sociodemographic and medical factors. Psychotropic use was also associated with the physical health of the respondent. The coexistence of physical and mental illness generated an increase of consumption, whereas the absence of both types of illness was associated with a very low rate. The rates for physical and for mental illness alone were intermediate and were almost equal.