A randomised controlled trial of biopsy forceps and cannula aspiration for transcervical chorionic villus sampling. A randomized study to assess two different techniques of aspiration while performing transabdominal chorionic villus sampling. Randomized clinical trial of transabdominal versus transcervical chorionic villus sampling methods. Effects of conventional physiotherapy, continuous positive airway pressure and non-invasive ventilatory support with bilevel positive airway pressure after coronary artery bypass grafting. Randomized trial comparing a radially expandable needle system with cutting trocars.
This trial compared two instruments for transcervical chorionic villus sampling (CVS).
                Randomised controlled trial.
                Regional university prenatal diagnosis and treatment centre.
                Two hundred women were randomised at 10(+0)-12(+6) weeks of gestation to transcervical CVS using cannula aspiration (CA) or biopsy forceps (BF).
                Women undergoing indicated CVS signed informed consent. Randomisation after decision to perform transcervical CVS.
                Primary outcome: the rise in maternal serum alpha-fetoprotein (alpha-FP). Secondary outcomes: (i) placental trauma (fetomaternal haemorrhage [FMH]); (ii) laboratory, procedure, and cytogenetic results and pregnancy outcomes; (iii) patient and operator satisfaction; and (iv) economic analyses. Analyses were performed by intention to treat.
                The -FP rise did not differ between groups; there was no other evidence of placental trauma. BF were better tolerated by women, provided culturable tissue, after fewer instrument passes, with greater ease and in less time. BF were associated with cost savings.
                Unlike -FP, other markers of FMH were unaltered, questioning the reliability of alpha-FP as an indicator of FMH. Compared with CA, transcervical BF caused comparable placental trauma, appeared to be similarly effective and safe and were preferred by operators and patients. The technique used to perform transabdominal chorionic villus sampling (CVS) is not standardized, but aspiration of villi is generally obtained by discontinuous vacuum created in a syringe, manually or by a hand-grip device. We evaluated the feasibility of a new method of performing CVS which employs a 4-mL Vacutainer connected to the needle, producing a continuous negative pressure.
                Two hundred pregnant women, whose gestational age ranged from 10 + 2 to 16 + 2 (mean, 12 + 1) weeks, entered the randomized study, which was powered to detect with 90% probability the absence of any difference in the size of chorionic samples obtained by using a 20-mL syringe with the vacuum obtained by a hand-grip device (Group 1) or by a vacutainer (Group 2). Four operators with different levels of experience performed all the procedures, which were done transabdominally using a freehand technique with a 20-gauge needle under ultrasound guidance.
                Maternal age, body mass index, gestational age and the way the needle was inserted within the chorion were similar in the two groups. The median amount of villi sampled was 20 mg, with no differences between the two groups. The rate of fetal loss was 1.7%. All losses occurred in women of Group 1 who had only one needle insertion. A second needle insertion was required more frequently while using the vacutainer.
                This new technique for performing transabdominal CVS uses a readily available device and is as effective as traditional sampling systems to aspirate villi. It has the advantage of being a one-operator procedure. The relative advantages and disadvantages of transabdominal (TA) and transcervical (TC) chorionic villus sampling (CVS) in terms of fetal risks and efficacy were evaluated in a clinical trial conducted on 1194 women randomized at 7-12 weeks' gestation. The results of the study indicate that, if any, the relative risk of fetal loss following either procedure is less than double that of the alternative technique when performed by a skilled operator. Overall, the fetal loss rate (spontaneous abortions following randomization, terminations of pregnancy, and perinatal deaths) is 16.5 and 15.5 per cent, respectively, among women allocated to TA- and TC-CVS. The two procedures are equally effective, although TA-CVS is associated with a significantly lower rate of repeat device insertions; on the other hand, a higher weight of chorionic tissue is obtained, on average, with TC-CVS. Bleeding is more common following TC-CVS, while peritoneal reaction developed only after TA-CVS. No diagnostic problems specifically related to one sampling technique were identified. Coronary artery bypass graft (CABG) surgery with the use of mammary arteries is associated with severe alteration of lung function parameters. The purpose of the present study was to compare the effect on lung function tests of conventional physiotherapy using incentive spirometry (IS) with non-invasive ventilation on continuous positive airway pressure (CPAP) and with non-invasive ventilation on bilevel positive airway pressure (BiPAP or NIV-2P), METHODS: Ninety-six patients were randomly assigned to 1 of 3 groups: NIV-2P (1 h/3 h), CPAP (1 h/3 h) and IS (20/2 h). Pulmonary function tests and arterial blood gases analyses were obtained before surgery. On the 1st and 2nd postoperative days, these parameters were collected together with cardiac output and calculation of venous admixture.
                For the 3 groups a severe restrictive pulmonary defect was observed during the 1st postoperative day. On the 2nd postoperative day, in opposition to IS, intensive use of CPAP and NIV-2P reduced significantly the venous admixture (P<0.001) and improved VC, FEV1 and PaO2 (P<0.01).
                We conclude that preventive use of NIV can be considered as an effective means to decrease the negative effect of coronary surgery on pulmonary function. Sharp trocar insertion for laparoscopic procedures carries with it increased risk for vascular and visceral complications and incisional hernia. In a trial, which randomized 87 patients to treatment with either sharp trocars or a radially expanding needle system with blunt dilator, results showed that with the latter system there was statistically improved patient assessment of pain, a lower complications rate, and shorter procedure time. In the group of patients randomized to treatment with conventional trocars, there were a total of six instrument-related adverse events (6/42): four cases (five incidences) of abdominal wall injuries and one small bowel perforation caused by a Veress needle. Of the 45 patients randomized to the blunt dilator/cannula treatment, there was one adverse event (1/45) that was unrelated to the blunt dilator/cannula system: Veress needle injury to abdominal vasculature. The radially expanding access system demonstrates statistically improved patient postoperative comfort and improved patient safety.
For transcervical CVS, although there is some evidence to support the use of small forceps instead of cannulae, the evidence is not strong enough to support change in practice for clinicians who have become familiar with a particular technique. For transabdominal CVS, based on current evidence, there is no difference in clinically important outcomes with the use of a continuous compared with a discontinuous negative pressure needle aspiration system.