The QUILT study: quilting sutures in patients undergoing breast cancer surgery: a stepped wedge cluster randomized trial study.

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.

[Late recognition of intestinal malrotation]. / Late herkenning van een intestinale malrotatie.

BACKGROUND: Intestinal malrotation is a congenital intestinal abnormality caused by abnormal intestinal rotation during foetal development. CASE DESCRIPTION: We describe a 20-year-old woman with many years' history of abdominal symptoms and eating disorders that were labelled as psychosomatic following repeated and extensive investigations. The diagnosis of malrotation was only made after an emergency laparotomy, with right hemicolectomy for intestinal necrosis. CONCLUSION: The reason that diagnosis was missed in this patient was probably not only because malrotation is accompanied by non-specific symptoms. The cognitive strategies used by doctors to make a diagnosis on the basis of symptoms may also have led to ignoring details that did not fit, and to clinging to earlier diagnoses. Furthermore, eating disorders and gastrointestinal disorders are sometimes difficult to distinguish and are often linked. Even with extra vigilance a misdiagnosis cannot always be avoided.

Predictive factors of ovarian response and clinical outcome after IVF/ICSI following a rFSH/GnRH antagonist protocol with or without oral contraceptive pre-treatment.

BACKGROUND: Prediction of ovarian response prior to the first controlled ovarian stimulation (COS) cycle is useful in determining the optimal starting dose of recombinant FSH (rFSH). However, potentially predictive factors may be subject to inter-cycle variability and many patients are pre-treated with oral contraceptives (OC) for scheduling purposes. Our objective was to determine predictive factors of ovarian response for patients undergoing COS with rFSH in a gonadotrophin-releasing hormone antagonist protocol and to determine the inter-cycle variability of these factors. METHODS: In this multinational trial, 442 patients were randomized to receive either OC treatment or no treatment prior to their first COS cycle. For candidate predictive factors, patient characteristics were collected at screening, and endocrine and sonographic data were collected during the early follicular phase of the two subsequent cycles. A treatment regimen of 200 IU rFSH and 0.25 mg ganirelix was applied during the second cycle. Predictive factors of ovarian response and of too low (<6 oocytes) or too high (>18 oocytes) ovarian responses were determined using stepwise linear regression and stepwise logistic regression, respectively. RESULTS: Anti-Müllerian hormone (AMH) and basal FSH were statistically significant predictors of the number of oocytes retrieved and of an excessive ovarian response. For low ovarian response, AMH was the only significant predictive factor. In the non-OC group, the predictive value was higher than in the OC group and higher at the early follicular phase of the stimulation cycle than of the previous cycle. The inter-cycle variation for AMH was low compared with the inter-cycle variation of other hormones. Between the two groups, there were no differences in the number or quality of embryos obtained or transferred, but the implantation rate was significantly lower in the OC group (24.1 versus 30.1%, P= 0.03), resulting in an ongoing pregnancy rate of 26.3% compared with 35.7% in the non-OC group (P= 0.05). CONCLUSIONS: The best predictive model of ovarian response was in the non-OC group and included both AMH and basal FSH determined at the early follicular phase of the stimulation cycle. In the proceeding cycle, AMH alone had sufficient predictive value since it was not affected by inter-cycle variability or OC pretreatment.

Current pathology work-up of extremity soft tissue sarcomas, evaluation of the validity of different techniques.

OBJECTIVE: In patients with extremity soft tissue sarcomas (STSs) a correct histopathological diagnosis is considered important before surgical treatment. We evaluated the preoperative use and sensitivity of the various pathology techniques. METHODS: In a population-based study in patients operated for a newly diagnosed extremity STS between January 2000 and December 2003 the preoperative pathology work-up was evaluated. Data were retrieved from a national pathology database (PALGA). The sensitivity of the three techniques was assessed considering an examination affirmative when the conclusion of the pathology report stated the presence of mesenchymal malignancy. RESULTS: The pathology reports of 573 patients were identified in the database. In 177 patients (31%) no pathology examination was done before resection of the tumour. In the remaining 396 patients the pathology procedure of first choice had been an incisional biopsy (IB) in 195 patients (49%), a core-needle biopsy (CNB) in 90 patients (23%) and a fine needle aspiration (FNA) in 111 patients (28%). An affirmative diagnosis was established in 95% of the patients following an IB, in 78% after a CNB and in 38% following FNA. After an initial CNB an additional IB was performed in 18 of the 90 patients improving the yield to 89%. After an initial FNA a subsequent histological biopsy was done in 53 of the 111 patients, increasing the sensitivity to 71%. CONCLUSIONS: In this population-based study in patients treated for extremity STS, the proportion of patients operated without preoperative pathology evaluation was high. In the remaining patients an incisional biopsy was still the most commonly performed technique with the highest yield.

Automatic correction for phase shifts, frequency shifts, and lineshape distortions across a series of single resonance lines in large spectral data sets.

A new model-free method is presented that automatically corrects for phase shifts, frequency shifts, and additional lineshape distortions of one single resonance peak across a series of in vivo NMR spectra. All separate phase and frequency variations are quickly and directly derived from the common lineshape in the data set using principal component analysis and linear regression. First, the new approach is evaluated on simulated data in order to quantitatively assess the phase and frequency shifts which can be removed by the proposed correction procedure. Subsequently, the value of the method is demonstrated on in vivo (31)P NMR spectra from skeletal muscle of the hind leg of the mouse focusing on the phosphocreatine resonance which is distorted by the experimental procedure. Phase shifts, frequency shifts, and lineshape distortions with respect to the common lineshape in the spectral data set could successfully be removed.