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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.

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.

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 7 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.,Laboratory for Microbiology | 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 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.

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