Interuniversity Center for Biostatistics and Statistical Bioinformatics

Leuven, Belgium

Interuniversity Center for Biostatistics and Statistical Bioinformatics

Leuven, Belgium
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Moonen A.,Catholic University of Leuven | Annese V.,AOU Careggi | Belmans A.,Interuniversity Center for Biostatistics and Statistical Bioinformatics | Varannes S.B.D.,University of Nantes | And 9 more authors.
Gut | Year: 2016

Objective: Achalasia is a chronic motility disorder of the oesophagus for which laparoscopic Heller myotomy (LHM) and endoscopic pneumodilation (PD) are the most commonly used treatments. However, prospective data comparing their long-term efficacy is lacking. Design:201 newly diagnosed patients with Achalasia were randomly assigned to PD (n=96) or LHM (n=105). Before randomisation, symptoms were assessed using the Eckardt score, functional test were performed and quality of life was assessed. The primary outcome was therapeutic success (presence of Eckardt score =3) at the yearly follow-up assessment. The secondary outcomes included the need for re-treatment, lower oesophageal sphincter pressure, oesophageal emptying and the rate of complications. Results: In the full analysis set, there was no significant difference in success rate between the two treatments with 84% and 82% success after 5 years for LHM and PD, respectively (p=0.92, log-rank test). Similar results were obtained in the per-protocol analysis (5-year success rates: 82% for LHM vs 91% for PD, p=0.08, log-rank test). After 5 years, no differences in secondary outcome parameter were observed. Redilation was performed in 24 (25%) of PD patients. Five oesophageal perforations occurred during PD (5%) while 12 mucosal tears (11%) occurred during LHM. Conclusions: After at least 5 years of follow-up, PD and LHM have a comparable success rate with no differences in oesophageal function and emptying. However, 25% of PD patients require redilation during follow-up. Based on these data, we conclude that either treatment can be proposed as initial treatment for Achalasia. Trial registration numbers Netherlands trial register (NTR37) and Current Controlled Trials registry (ISRCTN56304564).


Van Gysel M.,Regional Hospital Sint Maria | Cossey V.,University Hospitals Leuven | Fieuws S.,Interuniversity Center for Biostatistics and Statistical Bioinformatics | Schuermans A.,University Hospitals Leuven
European Journal of Pediatrics | Year: 2012

Growing evidence favours the use of human milk for the feeding of preterm newborns based on its many beneficial effects. Despite the many benefits, human milk has been associated as a possible vehicle of transmission for a number of infections. Although pasteurization of human milk can diminish the risk of neonatal infection, it also significantly reduces the concentrations of immunological components in human milk due to thermal damage. In order to evaluate the impact of pasteurization on the antibacterial properties of human milk, we aimed to compare the capacity of raw and pasteurized human milk to inhibit bacterial proliferation. Therefore, a single milk sample was collected from ten healthy lactating mothers. Each sample was divided into two aliquots; one aliquot was pasteurized, while the other was kept raw. Both aliquots were inoculated either with Escherichia coli or Staphylococcus aureus and incubated at 37 °C during 8 h. Viable colony counts from the inoculated samples were performed at regular time points to compare the bacterial growth in both forms of breast milk. Relative to the tryptic soy broth control sample, both raw and pasteurized milk samples exhibited an inhibitory effect on the growth of E. coli and S. aureus. Compared with the raw portion, growth inhibition was significantly lower in the pasteurized milk at every time point beyond T0 (after 2, 4 and 8 h of incubation) (p0 0.0003 for E. coli and p<0.0001 for S. aureus). Conclusion: Our study shows that pasteurization adversely affects the antibacterial properties of human milk. © Springer-Verlag 2012.


Wolthuis A.M.,University Hospital Leuven | Meuleman C.,Leuven University Fertility Center | Tomassetti C.,Leuven University Fertility Center | Dhooghe T.,Leuven University Fertility Center | And 3 more authors.
Human Reproduction | Year: 2011

BACKGROUND: Multidisciplinary laparoscopic treatment is the standard of care for radical treatment of deep infiltrating pelvic endometriosis. If bowel resection is necessary, a muscle-split or Pfannenstiel incision is also required. The avoidance of any laparotomy could decrease surgical stress response, give a faster return to normal bowel function, decrease post-operative pain and reduce wound complications and incisional hernias. We assessed post-operative outcome after a full laparoscopic sigmoid resection for bowel endometriosis.PATIENTS AND METHODSTwenty-one patients who underwent elective full laparoscopic sigmoid resection for bowel endometriosis from September 2009 to September 2010 were matched for age, American Society of Anesthesiologists class and BMI to 21 patients who underwent a conventional laparoscopic sigmoid resection. Groups were compared for peri-operative factors, complications, length of hospital stay, post-operative pain (Visual Analog Scale: VAS), analgesics consumption and inflammatory response (plasma C-reactive protein: CRP). Results Median operating time was 15 min shorter with transrectal specimen extraction (P = 0.003). VAS-scores and use of analgesics were higher in the conventional laparoscopic group (P = 0.0005). Mean CRP-level tended to be higher in the transrectal specimen extraction group (38, P = 0.054) but there was no difference in increase in CRP level between groups (P = 0.15). There were no anastomotic leaks or reinterventions in either group, and the median hospital stay was similar. At follow-up, no wound infections or incisional hernias were observed and no patients reported anal dysfunction. CONCLUSION Full laparoscopic sigmoid resection reduced operating times and decreased post-operative VAS-scores and analgesic requirements compared with the conventional laparoscopic sigmoid resection for bowel endometriosis. © The Author 2011. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.


van der Tol A.,Ghent University | van Biesen W.,Ghent University | van Laecke S.,Ghent University | Bogaerts K.,Interuniversity Center for Biostatistics and Statistical Bioinformatics | And 3 more authors.
PLoS ONE | Year: 2012

Background: Microalbuminuria (MAU) is considered as a predictor or marker of cardiovascular and renal events. Statins are widely prescribed to reduce cardiovascular risk and to slow down progression of kidney disease. But statins may also generate tubular MAU. The current observational study evaluated the impact of statin use on the interpretation of MAU as a predictor or marker of cardiovascular or renal disease. Methodology/Principal Findings: We used cross-sectional data of ERICABEL, a cohort with 1,076 hypertensive patients. MAU was defined as albuminuria ≥20 mg/l. A propensity score was created to correct for "bias by indication" to receive a statin. As expected, subjects using statins vs. no statins had more cardiovascular risk factors, pointing to bias by indication. Statin users were more likely to have MAU (OR: 2.01, 95%CI: 1.34-3.01). The association between statin use and MAU remained significant after adjusting for the propensity to receive a statin based on cardiovascular risk factors (OR: 1.82, 95%CI: 1.14-2.91). Next to statin use, only diabetes (OR: 1.92, 95%CI: 1.00-3.66) and smoking (OR: 1.49, 95%CI: 0.99-2.26) were associated with MAU. Conclusions: Use of statins is independently associated with MAU, even after adjusting for bias by indication to receive a statin. In the hypothesis that this MAU is of tubular origin, statin use can result in incorrect labeling of subjects as having a predictor or marker of cardiovascular or renal risk. In addition, statin use affected the association of established cardiovascular risk factors with MAU, blurring the interpretation of multivariable analyses. © 2012 van der Tol et al.


Wolthuis A.M.,University Hospital Gasthuisberg | Penninckx F.,University Hospital Gasthuisberg | Fieuws S.,Interuniversity Center for Biostatistics and Statistical Bioinformatics | D'Hoore A.,University Hospital Gasthuisberg
Colorectal Disease | Year: 2012

Aim With the introduction of single-port surgery, expected advantages are improved cosmesis, decrease of pain and shorter length of stay. The aim of this study was to compare early outcomes of single-port colectomy with those of conventional laparoscopic colectomy. Method All consecutive patients undergoing single-port colectomy between January and June 2010 were identified from a prospective database. They were matched for age, sex, body mass index, American Society of Anesthesiology score and type of resection with patients who had conventional laparoscopic colectomy. All perioperative data, analgesic requirement, pain scores and inflammatory response were compared using the Wilcoxon signed-rank and McNemar tests. Results Fourteen patients [five men, nine women; median age (interquartile range) 56 (30-73) years, body mass index (interquartile range) 22 (20-24) kg/m 2] underwent single-port colectomy and were matched with patients who had conventional laparoscopic colectomy. Median operating times, estimated blood loss, pain scores, analgesic requirement, inflammatory response and length of hospital stay were similar. Median increase in incision length was significantly higher in the single-port group (P=0.004), but maximal incision length for specimen extraction was comparable. There were no anastomotic leaks, wound infections or 30-day readmissions. Conclusion In a case-matched setting with a small sample size, single-port laparoscopic colectomy has comparable outcomes to conventional laparoscopic colectomy. © 2011 The Association of Coloproctology of Great Britain and Ireland.


Wolthuis A.M.,University Hospital Gasthuisberg | Penninckx F.,University Hospital Gasthuisberg | Haustermans K.,University Hospital Gasthuisberg | De Hertogh G.,University Hospital Gasthuisberg | And 3 more authors.
Annals of Surgical Oncology | Year: 2012

Background: The interval between neoadjuvant chemoradiotherapy and surgery for rectal cancer has arbitrarily been set at 6-8 weeks. However, tumor regression is variable. This study aimed to evaluate whether the interval between neoadjuvant therapy and surgery had an impact on pathologic response and on surgical and oncologic outcome. Methods: A total of 356 consecutive patients with clinical stage II and III rectal adenocarcinoma were identified. Median age was 63 years, and 65 % were men. All patients received neoadjuvant chemoradiotherapy (45 Gy) with a continuous infusion of 5-fluorouracil. Data on neoadjuvantsurgery interval, type of surgery, pathology, postoperative complications, length of hospital stay, disease recurrence, and survival were reviewed. Patients were divided into two groups according to the interval between neoadjuvant therapy and surgery: ≤7 weeks (short interval, n = 201) and >7 weeks (long interval, n = 155). Results: The complete pathologic response rate was 21 %. It was significantly higher after a longer interval (28 %) than after a shorter interval (16 %, p = 0.006). A longer interval did not affect morbidity or length of hospital stay. After a median follow-up of 4.9 years, the 5-year cancer-specific survival rate was 83 % in the short-interval group versus 91 % in the longinterval group (p = 0.046), and the free-from-recurrence rate was 73 versus 83 %, respectively (p = 0.026). Conclusions: Inthis retrospective analysis, there seems to be an association between a longer interval after neoadjuvant chemoradiotherapy and complete pathologic response without affecting postoperative morbidity and length of hospital stay, and with no detrimental effect on oncologic outcome. © Society of Surgical Oncology 2012.


Goossens G.A.,University Hospitals Leuven | Goossens G.A.,Catholic University of Leuven | Jerome M.,University Hospitals Leuven | Janssens C.,University Hospitals Leuven | And 8 more authors.
Annals of Oncology | Year: 2013

Background: Heparin has been used for years as a locking solution in totally implantable venous access devices. Normal saline (NS) might be a safe alternative for heparin. However, evidence of non-inferiority of NS versus heparin is lacking. Patients and methods: We randomly allocated 802 cancer patients with a newly inserted port either to heparin lock (300 U/3 ml) or to NS lock groups in a 1:1 assignment ratio. The primary outcome was the number of functional. © The Author 2013. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.


Cossey V.,University Hospitals Leuven | Vanhole C.,University Hospitals Leuven | Eerdekens A.,University Hospitals Leuven | Rayyan M.,University Hospitals Leuven | And 2 more authors.
Neonatology | Year: 2013

Background: Feeding preterm infants human milk has a beneficial effect on the risk of late-onset sepsis (LOS). Due to lack of microbiological standards, practices such as pasteurization of mother's own milk differ widely among neonatal intensive care units worldwide. Objectives: To investigate whether pasteurization of mother's own milk for very-low-birth-weight (VLBW) infants influences the incidence and severity of infection-related outcomes. Methods: In this randomized controlled trial, preterm infants (gestational age <32 weeks and/or birth weight <1,500 g) received either raw or pasteurized mother's own milk during the first 8 weeks of life. The primary outcome was the incidence of proven LOS. A dose-response relation was verified, i.e. the dependence of the risk of sepsis on the actual and cumulative quantities of mother's own milk. Results: This study included 303 VLBW infants (mean birth weight: 1,276 g; mean gestational age: 29 weeks) whose baseline and nutritional characteristics were similar. The incidence of laboratory-confirmed sepsis was not statistically different in infants fed raw milk compared to infants who received pasteurized milk: 22/151 (0.15, CI: 0.08-0.20) and 31/152 (0.20, CI: 0.14-0.27), respectively (RR: 0.71; 95% CI: 0.43-1.17). A significant dose-response relation was observed between the adjusted quantity of enteral feeding and the risk of LOS, regardless of the type of feeding. Conclusion: For preterm infants, pasteurization of mother's own milk shows a trend towards an increase in infectious morbidity, although no statistical significance was reached. Practices should focus on collection, storage and labeling procedures to ensure the safety and quality of expressed milk. Copyright © 2012 S. Karger AG, Basel.


Wolthuis A.M.,University Hospital Gasthuisberg Leuven | de Buck van Overstraeten A.,University Hospital Gasthuisberg Leuven | Fieuws S.,Interuniversity Center for Biostatistics and Statistical Bioinformatics | Boon K.,University Hospital Gasthuisberg Leuven | D'Hoore A.,University Hospital Gasthuisberg Leuven
Surgical Endoscopy and Other Interventional Techniques | Year: 2015

Background: In laparoscopic colorectal surgery, extraction site laparotomy can be avoided by natural orifice specimen extraction (NOSE) resulting in less postoperative pain, shorter length of stay, and less morbidity such as wound complications. To date, short-term outcome of a large prospective cohort of patients has not been studied. The aim of this prospective cohort study was to assess short-term outcome of laparoscopic left-sided NOSE-colectomy. Methods: Prospectively collected data of patients who had undergone elective laparoscopic NOSE-colectomy between July 2009 and December 2013 were analyzed retrospectively. Primary endpoint was short-term morbidity. Results: A total of 110 patients were included in this study. Median age was 38 years (IQR: 32–56), median BMI was 23 kg/m2 (IQR: 21–25), and 88 % of the patients were female. Sixty-three patients (57 %) underwent resection for endometriosis, 29 patients (26 %) for diverticular disease, 16 patients (15 %) for a tumor, and 2 patients for other indications. Median operating time was 85 min (IQR: 70–100) and median length of the extracted specimen was 20 cm (IQR: 16–25). Overall, 14 patients had a postoperative complication (13 %), of which 9 were Clavien-Dindo grade 1 or 2 (8 %). Four patients (3.6 %) had an intraluminal bleeding from the anastomosis, which was treated endoscopically. There was 1 anastomotic leak (1 %), treated by emergency laparotomy and creation of a new colorectal anastomosis (grade 3b). The median hospital stay was 5 days (IQR: 4–6). Conclusion: Laparoscopic NOSE-colectomy is safe and feasible with good short-term outcome. This study concerning a standardized operative technique is the first in literature reporting on a large group of patients. © 2014, Springer Science+Business Media New York.


Wolthuis A.M.,University Hospital Gasthuisberg Leuven | Van Geluwe B.,University Hospital Gasthuisberg Leuven | Fieuws S.,Interuniversity Center for Biostatistics and Statistical Bioinformatics | Penninckx F.,University Hospital Gasthuisberg Leuven | D'Hoore A.,University Hospital Gasthuisberg Leuven
Colorectal Disease | Year: 2012

Aim A systematic review was performed to identify differences in surgical technique, postoperative morbidity, length of hospital stay and safety for procedures involving left-sided laparoscopic colectomy with natural orifice specimen extraction. Method A PubMed search was performed to retrieve studies reporting on left-sided laparoscopic colorectal resection with transrectal specimen extraction. The quality of the different reports was assessed according to the Newcastle-Ottawa Scale. Six studies were included and all but one were cohort studies. Studies on transanal, transvaginal or transcolonic specimen extraction were excluded, as were reports on paediatric surgery. Results Six papers (including 94 patients) fulfilled the search criteria. The techniques reported were not standardized and this technical heterogeneity hampered pooled analysis. A meta-analysis could also not be performed because of differences in inter-study methods, study population and results. All studies showed, nevertheless, that the technique is feasible with low morbidity and short postoperative hospital stay. No anal dysfunction was reported. Conclusion To date, the evidence in favour of left-sided laparoscopic colectomy with transrectal specimen extraction is weak (level IV-V). Future clinical research should focus on standardization of the technique. Randomized controlled trials are necessary to show the superiority of this approach with regard to postoperative pain and morbidity, hospital stay, recovery, function and cosmesis. © 2011 The Authors Colorectal Disease © 2011 The Association of Coloproctology of Great Britain and Ireland.

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