Optimised gynaecological examination with a new pelvic examination chair.

OBJECTIVE: The present aim was to contribute to improving the traditional pelvic examination chair with vertical leg support and to evaluate patients' and examiners' experience of a new gyneacological and urological examination chair with heated upholstery. STUDY DESIGN: A new gynaecological and urological examination chair was constructed with laterally adjustable leg support, a foot-plate and the perineum exposed only during the examination procedure. Patients (n = 131) with or without endometriosis were invited to participate in an anonymous questionnaire survey concerning how they experienced a gynaecological examination. MAIN OUTCOME MEASURES: The patients and the gynaecologists who performed the examinations answered questionnaires evaluating the examination procedure in the traditional and in the new gynaecological and urological examination chair, respectively. The questionnaires asked about comfort, heating, integrity and the experience of pelvic examination with vertical or lateral leg support. The examination times were measured with a stop-watch. RESULTS: The majority of the answers (n = 131) were significantly (p < 0.05-0.001) in favour of the new concept with lateral leg support and with increased comfort and integrity. The average examination time was significantly shortened and the patients more relaxed in the new gynaecological and urological examination chair. CONCLUSION: The traditional gynaecological chair with vertical leg support has remained basically unchanged for many years. The present study showed that the pelvic examination procedure can be significantly optimized with easy patient-friendly adaptations.

Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis.

OBJECTIVES: The minimal important difference can be helpful in interpreting data from clinical trials. The objective of the study was to calculate the minimal important difference for improvement on the VAS scale for women with endometriosis. STUDY DESIGN: A prospective study was conducted to evaluate the effect of pertubation with lignocaine on dysmenorrhea and quality of life in women with endometriosis. Data collected in the trial were used for additional analyses in the present descriptive study. Eligible women (n=37) had endometriosis with pain>VAS 50mm (visual analogue scale). MAIN OUTCOME MEASURES: In a questionnaire, women evaluated their maximum pain on the VAS- scale during every menstrual period before and after treatment. They also estimated the changes in overall pain level by answering the response categories "much better", "somewhat better", "about the same", "somewhat worse" or "much worse". The women were grouped according to their own estimation of change in pain intensity after four months. The minimal important differences for change on the VAS scale correlate to the mean change for women who felt "somewhat better" (n=18) excluding those who were pain free (n=2). RESULTS: The minimal important difference for improvement on the VAS scale was found to be -39mm and/or -49%. CONCLUSION: If the patients have a pain level of at least 50mm on VAS scale at inclusion, the cut off for success in clinical trials is suggested to be defined as an either >40mm or a >50% decrease on VAS scale. Trial registry ClinicalTrials.gov Identifier: NCT01329796.

Effect of Lignocaine on IL-6, IL-8, and MCP-1 in Peritoneal Macrophages and Endometriotic Stromal Cells.

OBJECTIVE: The objective was to evaluate the effect of lignocaine on cytokine expression and secretion in vitro in peritoneal fluid macrophages and endometriotic stromal cells. DESIGN: Experimental in vitro study on human cells. POPULATION AND SAMPLE: Peritoneal fluid (n = 10) and samples from endometriotic cysts (n = 7) were collected from 13 women (women with endometriosis n = 8, and healthy controls n = 5) during surgery for clinical reasons. METHODS: Macrophages from the peritoneal fluid and cells from the inside of the endometriotic cysts capsules were isolated and cultivated for 24 to 48 hours in medium with and without the supplement of lignocaine 0.1 or 1.0 mg/mL. Relative gene expression of monocyte chemotactic protein 1 (MCP-1), interleukin 6 (IL-6), and IL-8 was evaluated with quantitative polymerase chain reaction and compared between treated and untreated cells with Wilcoxon matched pairs. The concentrations of MCP-1, IL-6, and IL-8 were measured using enzyme-linked immunosorbent assay and were compared between treated and untreated cells with Wilcoxon matched pairs. RESULTS: The gene expression and protein secretion of IL-8 in endometriotic stromal cells after incubation with lignocaine 0.1 mg/mL were significantly decreased after 24 hours compared to the controls ( P = .028 and P = .018). Macrophages from healthy controls had a significant lower gene expression of all tested cytokines ( P = .043) after treatment with lignocaine, but there were no significant differences in protein level. Macrophages from women with endometriosis showed diverging results since 3 of 5 samples showed increased gene expression of 1 (n = 2) or 2 cytokines (n = 1) after lignocaine treatment. CONCLUSION: Lignocaine can affect the gene expression and secretion of some proinflammatory cytokines in vitro.

Transducer hygiene: comparison of procedures for decontamination of ultrasound transducers and their use in clinical practice.

BACKGROUND: To determine whether current hygiene practices are appropriate during sonographic examinations. METHODS: Five major hospitals in Sweden were investigated with a survey. At each hospital, the departments corresponding to the main types of sonographic examination were chosen. Personnel who were responsible for or acquainted with the local hygiene procedures completed a standardardized questionnaire. RESULTS: The surveys were completed by 25 departments, where the total number of sonographic examinations was approximately 20,000 per month. For transvaginal and transrectal sonographic examinations, the most common method for decontamination of the transducer was barrier protection during the procedure followed by cleansing with alcohol. Latex was the predominant cover material, but one department used polyethylene gloves, and another department used nitrile gloves. Both of these involved transvaginal ultrasonography. In transcutaneous examinations, all hospitals were using alcohol and paper or cloth for decontamination at a minimum. Transesophageal examinations were carried out without barrier protection, and decontamination was performed with an alkylating substance. CONCLUSIONS: The hygiene practices appear to be appropriate at most hospitals, but there is a prevalence of transducer cover materials of unacceptable permeability, as well as use of gloves on transducers despite insufficient evidence of safety.

Quality of life in patients with endometriosis and the effect of pertubation with lidocaine - a randomized controlled trial.

OBJECTIVE: Pertubation with lidocaine has been shown to reduce pain (on a VAS-scale) in women with endometriosis. A clinical study was performed to evaluate the effect of lidocaine pertubations on quality of life. DESIGN: Double-blind, randomized and controlled trial. SETTING: Three outpatient units in Stockholm, Sweden. POPULATION: Eligible patients had endometriosis with dysmenorrhoic pain >VAS 50 mm. METHODS: The patients were randomized to pre-ovulatory pertubations with lidocaine (n = 24) or placebo (n = 18) during three consecutive menstrual cycles. The procedure comprised passing the solution through the uterus and the Fallopian tubes via an intracervical balloon catheter. The effect was evaluated with the validated Endometriosis Health Profile-30 questionnaire before and after treatments. MAIN OUTCOME MEASURES: Changes in scores at six and 12 months from baseline were compared between the groups with the Mann-Whitney U-test. RESULTS: After 6 months there was a significant difference between the lidocaine (n = 19) and the placebo (n = 16) groups for the dimension social support (median -18.8 vs. -6.3, p = 0.034), whereas there were no significant differences for the other dimensions after 6 or 12 months. The mean changes in the lidocaine group were above the minimal important difference levels in eight of 12 measurements of quality of life dimensions compared with two of 12 in the placebo group. CONCLUSIONS: This clinical trial indicates that pertubations with lidocaine might improve the social support dimension of quality of life in patients with endometriosis.

Serum concentration of lignocaine after pertubation: an observational study.

OBJECTIVE: The objective of this study was to report the serum concentration of lignocaine after pertubation in patients with endometriosis. DESIGN: Prospective observational study. SETTING: The study was carried out at a gynaecological outpatient unit in Stockholm, Sweden. POPULATION: Eligible patients had endometriosis with a dysmenorrhoic pain score of >50 mm on a visual analogue scale, and patent fallopian tubes. METHODS: Patients with endometriosis (n = 25) were included in the study. The patients received pre-ovulatory pertubations with lignocaine hydrochloride 10 mg (n = 16) or ringer acetate (placebo, n = 9). The procedure comprised passing the study solution through the uterus and the fallopian tubes via an intra-cervical balloon catheter. Serum samples were collected at 0, 5, 15 and 30 min after pertubation. MAIN OUTCOME MEASURES: The serum samples were analysed for the concentration of lignocaine with an LCMS-SIM method. RESULTS: Low levels of lignocaine were detected in the serum samples following pertubation of 10 mg lignocaine hydrochloride. The highest observed concentration was seen after 30 min (mean 0.050 µg/ml), with an individual maximum of 0.124 µg/ml. Maximum concentration (C max) and time to C max (T max) could not be calculated, since the highest values were observed in the 30-min samples, which was the last sample obtained. Lignocaine was not detected after pertubation with placebo. CONCLUSIONS: The serum levels of lignocaine following pertubation of 10 mg lignocaine hydrochloride are detectable but low. Lignocaine pertubated through the fallopian tubes reaches the peritoneal cavity and diffuses through the peritoneum into the blood circulation. Pertubation with lignocaine is safe and has no lignocaine-related adverse events.

Pertubation with lidocaine--a non-hormonal, long-term treatment of dysmenorrhea due to endometriosis.

The major symptoms of endometriosis are dysmenorrhea and infertility. Pertubations with lidocaine have been shown to reduce dysmenorrhea and have an enhancing effect on fertility. Different concentrations of lidocaine were evaluated in a randomized, double-blind study of pre-ovulatory pertubations with lidocaine solutions in women with dysmenorrhea. The patients had laparoscopically diagnosed endometriosis and normal fallopian tubes. Ninety pertubations were carried out without complications on 26 patients during up to six cycles. The effect was evaluated by means of questionnaires where a clinically significant reduction of dysmenorrhea was reported. Pertubation with lidocaine can be a non-hormonal treatment option for dysmenorrhea.

A new rapid and effective method for treatment of unexplained infertility.

BACKGROUND: Artificial insemination (intrauterine insemination by husband or artificial insemination by husband) is often tried as first treatment for couples with unexplained infertility. Pertubation has previously proved to increase the chance of achieving pregnancy for these couples. The effect of pertubation on fertility can be mechanical as well as anti-inflammatory by using a substance that inhibits phagocytosis of the spermatozoa.The objective of the study was to investigate the effect on pregnancy rate of pre-ovulatory pertubation with low-dose lignocaine during clomiphene citrate and insemination cycles for couples with unexplained infertility. METHODS: Ina prospective, open study, the patients were randomized, the day before ovulation, during a clomiphene citrate stimulated cycle to either pertubation with low-dose local anaesthetic or no pertubation before insemination. RESULTS: A total of 130 cycles were studied, 67 of which were randomized to pre-ovulatory pertubation and 63 to no pertubation treatment. There were 14.9% (n 5 10) clinical pregnancies in the pertubated group compared with 3.2% (n 5 2) in the group without pre-ovulatory pertubation (P < 0.05). CONCLUSIONS: The pertubation treatment significantly enhanced the clinical pregnancy rate and was well tolerated. No complications were noted. The combined treatment of clomiphene citrate, pertubation and insemination can be used as a cost-effective, first-line treatment for couples with unexplained infertility.

Glove powder in the hospital environment -- consequences for healthcare workers.

OBJECTIVE: Exposure to starch powder from natural rubber latex medical gloves can cause allergy symptoms among healthcare employees and impair working conditions, due to the absorption of latex protein antigens onto the starch powder on the gloves. To evaluate and take care of this problem at Stockholm Söder Hospital we carried out this study. METHODS: A questionnaire was distributed to all employees working within the medical centre. The procedure was repeated after the centre had been changed to a powder-free working environment. The focus of the questions was to determine the extent of symptoms that could be associated with glove powder or latex proteins. RESULTS: Responses were compared before and 8 months after a new powder-free glove policy was fully implemented. The study pointed out that a relatively high percentage of the hospital workers were suffering from glove-related symptoms. A significant reduction of itching on the hands, hand eczema and upper respiratory-tract disorders was found after the change to a powder-free environment. CONCLUSION: It is not acceptable to use powdered medical gloves within health care. In spite of the risk of allergy and impairment of the working environment from powdered gloves, there is still only a minority of hospitals working according to a strict general powder-free policy. This study has pointed out that the reduced cost resulting from reduced absence through sickness further adds an argument for omitting glove powder and can justify the higher cost of using powder-free medical gloves.