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Background Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting suture technique, in which the skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. However, implementation is lagging due to unknown side effects, increase in operation time and cost effectiveness. Main objective of this study is to assess the impact of large scale implementation of the quilting suture technique in patients undergoing mastectomy and/or axillary lymph node dissection (ALND). Methods The QUILT study is a stepped wedge design study performed among nine teaching hospitals in the Netherlands. The study consists of nine steps, with each step one hospital will implement the quilting suture technique. Allocation of the order of implementation will be randomization-based. Primary outcome is ‘textbook outcome’, i.e.no wound complications, no re-admission, re-operation or unscheduled visit to the outpatient clinic and no increased use of postoperative analgesics. A total of 113 patients is required based on a sample size calculation. Secondary outcomes are shoulder function, cosmetic outcome, satisfaction with thoracic wall and health care consumption. Follow-up lasts for 6 months. Discussion This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. We hypothesize that quilting is a simple technique to increase textbook outcome, enhance patient comfort and reduce health care consumption.

Background In the Netherlands, two performance indicators for the treatment of hip fracture patients have been recently implemented. Both indicators state that surgery within 24 h after admission improves the outcome with regard to 1-year mortality and the amount of re-operations within 1 year. To determine the value of these performance indicators, we conducted a retrospective analysis of 941 hip fracture patients. Methods In the period from January 2003 to December 2006, a total of 941 consecutive hip fracture patients were included in this study. We determined the amount of re-operations and the mortality at 1 year after surgery. From June 2005 to December 2006, we could determine whether patients were operated on within 24 h after admission. In this group of 379 patients, we determined if there were differences in the 1-year mortality and the number of re-operations at 1 year with regard to the time window in which these patients were operated on (<24 h or >24 h). Results Our overall mortality rate at 1 year is 21% (202 patients) and the amount of re-operations within 1 year is 8% (77 procedures). In our subgroup analysis, we found no significant difference in mortality or re-operations if patients were operated on within 24 h or not (number needed to treat of 59 and −31, respectively). Conclusion We conclude that hip fracture surgery within 24 h does not provide significantly better results in terms of 1-year mortality and the amount of re-operations within 1 year.

Background Conversion and anastomotic leakage in colorectal cancer surgery have been suggested to have a negative impact on long-term oncologic outcomes. The aim of this study in a large Dutch national cohort was to analyze the influence of conversion and anastomotic leakage on long-term oncologic outcome in rectal cancer surgery. Methods Patients were selected from a retrospective cross-sectional snapshot study. Patients with a benign lesion, distant metastasis, or unknown tumor or metastasis status were excluded. Overall (OS) and disease-free survival (DFS) were compared between laparoscopic, converted, and open surgery as well as between patients with and without anastomotic leakage. Results Out of a database of 2095 patients, 638 patients were eligible for inclusion in the laparoscopic, 752 in the open, and 107 in the conversion group. A total of 746 patients met the inclusion criteria and underwent low anterior resection with primary anastomosis, including 106 (14.2%) with anastomotic leakage. OS and DFS were significantly shorter in the conversion compared to the laparoscopic group ( p  = 0.025 and p  = 0.001, respectively) as well as in anastomotic leakage compared to patients without anastomotic leakage ( p  = 0.002 and p  = 0.024, respectively). In multivariable analysis, anastomotic leakage was an independent predictor of OS (hazard ratio 2.167, 95% confidence interval 1.322–3.551) and DFS (1.592, 1077–2.353). Conversion was an independent predictor of DFS (1.525, 1.071–2.172), but not of OS. Conclusion Technical difficulties during laparoscopic rectal cancer surgery, as reflected by conversion, as well as anastomotic leakage have a negative prognostic impact, underlining the need to improve both aspects in rectal cancer surgery.

Background Congenital diaphragmatic hernia (CDH) is a severe congenital anomaly of the diaphragm resulting in pulmonary hypoplasia and pulmonary hypertension. It is associated with a high risk of mortality and pulmonary morbidity. Previous retrospective studies have reported high frequency oscillatory ventilation (HFO) to reduce pulmonary morbidity in infants with CDH, while others indicated HFO to be associated with worse outcome. We therefore aimed to develop a randomized controlled trial to compare initial ventilatory treatment with high-frequency oscillation and conventional ventilation in infants with CDH. Methods/design This trial is designed as a multicentre trial in which 400 infants (200 in each arm) will be included. Primary outcome measures are BPD, described as oxygen dependency by day 28 according to the definition of Jobe and Bancalari, and/or mortality by day 28. All liveborn infants with CDH born at a gestational age of over 34 weeks and no other severe congenital anomalies are eligible for inclusion. Parental informed consent is asked antenatally and the allocated ventilation mode starts within two hours after birth. Laboratory samples of blood, urine and tracheal aspirate are taken at the first day of life, day 3, day 7, day 14 and day 28 to evaluate laboratory markers for ventilator-induced lung injury and pulmonary hypertension. Discussion To date, randomized clinical trials are lacking in the field of CDH. The VICI-trial, as the first randomized clinical trial in the field of CDH, may provide further insight in ventilation strategies in CDH patient. This may hopefully prevent mortality and morbidity. Trial registration Netherlands Trial Register (NTR): NTR1310

Background The time interval between CRT and surgery in rectal cancer patients is still the subject of debate. The aim of this study was to first evaluate the nationwide use of restaging magnetic resonance imaging (MRI) and its impact on timing of surgery, and, second, to evaluate the impact of timing of surgery after chemoradiotherapy (CRT) on short- and long-term outcomes. Methods Patients were selected from a collaborative rectal cancer research project including 71 Dutch centres, and were subdivided into two groups according to time interval from the start of preoperative CRT to surgery (< 14 and ≥ 14 weeks). Results From 2095 registered patients, 475 patients received preoperative CRT. MRI restaging was performed in 79.4% of patients, with a median CRT–MRI interval of 10 weeks (interquartile range [IQR] 8–11) and a median MRI–surgery interval of 4 weeks (IQR 2–5). The CRT–surgery interval groups consisted of 224 (< 14 weeks) and 251 patients (≥ 14 weeks), and the long-interval group included a higher proportion of cT4 stage and multivisceral resection patients. Pathological complete response rate ( n  = 34 [15.2%] vs. n  = 47 [18.7%], p  = 0.305) and CRM involvement (9.7% vs. 15.9%, p  = 0.145) did not significantly differ. Thirty-day surgical complications were similar (20.1% vs. 23.1%, p  = 0.943), however no significant differences were found for local and distant recurrence rates, disease-free survival, and overall survival. Conclusions These real-life data, reflecting routine daily practice in The Netherlands, showed substantial variability in the use and timing of restaging MRI after preoperative CRT for rectal cancer, as well as time interval to surgery. Surgery before or after 14 weeks from the start of CRT resulted in similar short- and long-term outcomes.