Does ovarian suspension following laparoscopic surgery for endometriosis reduce postoperative adhesions? An RCT.

STUDY QUESTION: Is temporary ovarian suspension following laparoscopic surgery for severe pelvic endometriosis an effective method for reducing the prevalence of postoperative ovarian adhesions? SUMMARY ANSWER: Temporary ovarian suspension for 36-48 h following laparoscopic treatment of severe endometriosis does not result in a significant reduction of postoperative ovarian adhesions. WHAT IS KNOWN ALREADY: Pelvic adhesions often develop following laparoscopic surgery for severe pelvic endometriosis. Adhesions can cause chronic pelvic pain and fertility problems compromising the success of treatment. Small observational studies suggested that temporary postoperative ovarian suspension to the abdominal wall may significantly reduce the prevalence of postoperative ovarian adhesions. STUDY DESIGN, SIZE, DURATION: This was a prospective within group comparison double-blind RCT. We recruited premenopausal women with severe pelvic endometriosis who required extensive laparoscopic surgery with preservation of the uterus and ovaries. Severity of the disease and eligibility for inclusion were determined at surgery. A total of 55 women were randomized to unilateral ovarian suspension for 36-48 h, 52 of which were included in the final analysis. Both ovaries were routinely suspended to the anterior abdominal wall during surgery. At the end of the operation, each woman was randomized to having only one ovary suspended postoperatively. The suture suspending the contralateral ovary was cut and a new transabdominal suture was inserted to act as a placebo. Both sutures were removed 36-48 h after surgery prior to discharge. Three months after surgery, all women attended for a detailed transvaginal ultrasound scan to assess ovarian mobility. Both the women and the ultrasound operators were blinded as to the side of postoperative ovarian suspension. The primary outcome was the prevalence of ovarian adhesions as described on ultrasound examination. Secondary outcomes were the severity of adhesions and the presence and intensity of postoperative pain. PARTICIPANTS/MATERIALS, SETTING, METHODS: All 55 participants had severe pelvic endometriosis confirmed at laparoscopy. As each participant had only one of their ovaries suspended at the end of surgery, they acted as their own control. MAIN RESULTS AND THE ROLE OF CHANCE: The median interval between ovarian suspension and postoperative scan was 99 days (interquartile range 68-114). There was no significant difference (P = 0.23) in the prevalence of postoperative ovarian adhesions between the suspended (20/52) and unsuspended (27/52) side (38.5 versus 51.9%) [odds ratio 0.56 (95% confidence interval 0.22-1.35)]. LIMITATIONS, REASONS FOR CAUTION: Ovaries were suspended postoperatively for 36-48 h. Longer suspension could result in lower prevalence of postoperative adhesions. WIDER IMPLICATIONS OF THE FINDINGS: The value of temporary ovarian suspension in women having surgery for mild-to-moderate endometriosis should be investigated further. The potential benefits of other adhesion prevention strategies, such as surgical barrier agents, in women undergoing surgical treatment for severe pelvic endometriosis should also be explored. STUDY FUNDING/COMPETING INTERESTS: E.S. received honoraria from Ethicon for provision of training to healthcare professionals and consultancy fees from Bayer. W.H. was supported by the research fund provided by the Gynaecology Ultrasound Centre, London UK. A.C. is on the advisory board for surgical innovations for which he receives an annual honorarium. A.C. also received support for courses and education from Storz and Johnson and Johnson and support for clinical nursing from Covidien and Lotus. The other authors declared no competing interests. TRIAL REGISTRATION NUMBER: Current Controlled Trials ISRCTN24242218.

Safety of Atrovent® CFC-free inhaler: respiratory events reported from an observational cohort study in England.

OBJECTIVES: The aim of the study was to identify any unexpected clinical events associated with starting the new CFC-free formulation of Atrovent® MDI in general practice in England. METHODS: An active surveillance cohort study was conducted with a focus on selected clinical events, including respiratory symptoms, in past users of Atrovent® CFC MDI ('switchers') and Atrovent® naïve users. Incidence density rate ratios (with 99% confidence intervals) for events occurring in the first 3 months of exposure (risk period-ID1-3 ) compared to 3 months prior to starting treatment (reference period-IDR ) were calculated. RESULTS: The cohort consisted of 13 211 patients (median age 70 years, 50.1% female; 63.5% prior users of Atrovent® CFC MDI ('switchers')). Common respiratory events occurred at higher rates after starting treatment than before for switchers, for example lower respiratory tract infection (LRTI) [ID1 /IDR = 1.45 (99% CI: 1.17, 1.81)] and worsening asthma [ID1 /IDR = 1.58 (99% CI: 1.00, 2.51)]. Of these events only LRTI was significant for Atrovent® naïve patients [ID1 /IDR = 1.42 (99% CI: 1.04, 1.95)]. CONCLUSIONS: The results of this study suggest effect modification of risk as a result of prior Atrovent® CFC MDI use. Overall, Atrovent® CFC-free MDI appeared to be reasonably well tolerated in the immediate postmarketing period and the safety profile appeared similar to that of the CFC formulation.

Effect of healthcare-acquired infection on length of hospital stay and cost.

OBJECTIVE: To estimate the independent effect of a single lower respiratory tract infection, urinary tract infection, or other healthcare-acquired infection on length-of-stay and variable costs and to demonstrate the bias from omitted variables that is present in previous estimates. DESIGN: Prospective cohort study.Setting. A tertiary care referral hospital and regional district hospital in southeast Queensland, Australia. PATIENTS: Adults aged 18 years or older with a minimum inpatient stay of 1 night who were admitted to selected clinical specialities. RESULTS: Urinary tract infection was not associated with an increase in length of hospital stay or variable costs. Lower respiratory tract infection was associated with an increase of 2.58 days in the hospital and variable costs of AU $24, whereas other types of infection were associated with an increased length of stay of 2.61 days but not with variable costs. Many other factors were found to be associated with increased length of stay and variable costs alongside healthcare-acquired infection. The exclusion of these variables caused a positive bias in the estimates of the costs of healthcare-acquired infection. CONCLUSIONS: The existing literature may overstate the costs of healthcare-acquired infection because of bias, and the existing estimates of excess costs may not make intuitive sense to clinicians and policy makers. Accurate estimates of the costs of healthcare-acquired infection should be made and used in appropriately designed decision-analytic economic models (ie, cost-effectiveness models) that will make valid and believable predictions of the economic value of increased infection control.

Factors associated with health care-acquired urinary tract infection.

BACKGROUND: Health care-acquired urinary tract infection is common, and the risk factors should be understood by those who manage hospitalized patients and researchers interested in interventions and programs designed to reduce rates. METHODS: We used multivariable logistic regression to identify factors that demonstrated a statistical association with infection. RESULTS: The incidence rate for infection was 1.66%, and risks increased for patients with prolonged length of stay (odd ratio [OR], 5.28; 95% confidence interval [CI]: 2.46-11.34), urinary catheter (OR, 5.16; 95% CI: 2.84-9.36), unresolved spinal injury (OR, 4.07; 95% CI: 1.04-15.92), transfer to/from another hospital (OR, 2.9; 95% CI: 1.39-6.04), some assistance for daily living prior to admission (OR, 2.58; 95% CI: 1.51-4.41), underlying neurologic disease (OR, 2.59; 95% CI: 1.49-4.49), previous stroke (OR, 1.94; 95% CI: 1.03-3.67), and fracture or dislocation on admission (OR, 3.34; 95% CI: 1.75-6.38). Male sex was protective (OR, 0.44; 95% CI: 0.26-0.77). CONCLUSION: Our data describe a general hospital population and therefore have relevance to many hospital-based health care professionals. The statistical model is a good fit to the data and has good predictive power. We identify high-risk groups and confirm the need for good decision making for managing the risks of health care-acquired urinary tract infection. This requires information on the effectiveness of risk-reducing strategies and the changes to economic costs and health benefits that result and the synthesis of these data in appropriately designed economic models.

Three successful interventions in health care workers that improve compliance with hand hygiene: is sustained replication possible?

BACKGROUND: Hand hygiene (HH) compliance by health care workers has been universally disappointing. Two major programs (Washington and Geneva) have demonstrated interventions that induce sustained improvement. The introduction of alcohol-based hand rub (AHR) together with education also has been reported to improve compliance. METHODS: These interventions were replicated concurrently for 2 years in selected wards of an 800-bed university teaching hospital, with compliance assessed only within, not between, programs. RESULTS: No significant improvement in HH compliance was observed after the introduction of AHR (incidence rate ratio [IRR] = 1.11; 95% confidence interval [CI] = 0.93 to 1.33; P = .238) or substitution of AHR for a similar product (IRR = 1.10; 95% CI = 0.91 to 1.32; P = .328) with concomitant education. The Washington program achieved a 48% (IRR = 1.48, 95% CI = 1.20 to 1.81; P < .001) improvement in compliance, sustained over 2 years. The Geneva program failed to induce a significant increase in HH compliance in 3 wards, but achieved a 56% (IRR = 1.56; 95% CI = 1.29 to 1.89; P < .001) improvement over the already high HH rate in 1 ward (infectious disease unit). CONCLUSIONS: The Washington program demonstrated effectiveness in achieving sustained improved HH compliance, whereas the effect of the Geneva program was limited in those wards without strong medical leadership. Introduction of AHR without an associated behavioral modification program proved ineffective.