Title: Patient preferences for uterine preservation and hysterectomy in women with pelvic organ prolapse Presenter:

Title: Sexual function and the surgical management of breast cancer Presenter: Michaela Onstad, MD, MPH Preceptor: Jennifer Gass, MD Other authors: Erin Kunkel, Melissa A. Clark, PhD, Vrishali Lopes, MS Objective: Women diagnosed with early stage breast cancer may be managed surgically with lumpectomy followed by radiation, mastectomy alone, or mastectomy with reconstructive procedures, all demonstrating equal survival outcomes. Prior research has shown that sexual dysfunction among women with breast cancer is common, however the association between the type of surgery a woman undergoes and her sexual function has not been well studied. We aim to evaluate the association between each of these surgical modalities and a woman’s sexual function, as measured by the Female Sexual Function Index (FSFI). Methods: This study involves women who underwent breast cancer surgery at Women and Infants Hospital between the years 2000-2010 and receive follow up care at the Breast Health Center. We excluded patients less than 21 years old at surgery and women with a known diagnosis of a sexual disorder prior to surgery. The study involves a survey and a retrospective chart review. The survey includes the FSFI and investigator-generated questions. Demographic and medical data are extracted from the medical record to explore for potential confounders. The primary outcome is the numeric FSFI score. Secondary outcomes include subdivided FSFI category scores and responses to investigator-generated questions. Assuming an FSFI score of 20 for patients undergoing lumpectomy, in order to detect a score difference of 2 points, with power set at 80%, the sample size needed is 50 patients. Results: Final results are to be presented at time of presentation. Preliminary data demonstrates a mean FSFI score of 18.9 for patients who underwent lumpectomy, 27.8 for patients who underwent mastectomy alone, and 2.2 for patients who underwent mastectomy with reconstruction. These values are not statistically significant, and they represent a small portion of respondents with remaining data collection still underway. Conclusion: There may be an association between surgical modality for early breast cancer and sexual function. If such an association exists, this would be valuable in counseling patients about surgical options. Title: Increased False Positive Rate of the Integrated Screen in the HIV Positive Population Presenter: Andrea B. Rollins, MD Preceptor: Brenna Anderson, MD (add Brenna’s other degrees) Other author: Vrishali Lopes, MS Objective: Based on prior study results evaluating other aneuploidy screening tests, we hypothesize that HIV positive pregnant women will have an increased risk of false positive rate on integrated screening compared to HIV negative women. Methods: A retrospective chart review of HIVpositive pregnant women, who underwent integrated screening as part of their prenatal care is being performed. Patient demographic and clinical data as well as postnatal fetal evaluations is being collected. Variables are being compared by chi-square, Fishers exact test, T-test or nonparametric Wilcoxon sum rank test. Odds ratios and 95% confident intervals will be calculated for the outcomes and multivariable logistic regression will be used to adjust for any potential confounders. Assuming a false positive baseline rate of 5% among HIV negative pregnant women a sample size of 112 HIV positive pregnant women and 224 controls are required for the study to detect a three-fold increase in the false positive rate in this population. A two sided alpha of 5% and power of 80% are being used. Results: So far 18 HIV positive pregnant women and 20 controls have been entered in the study database. Preliminary data analysis has demonstrated a statistically significant difference in age, BMI and race between the two groups, with controls being younger (25 vs. 30 years old), having lower BMIs (23.3 vs. 31.4) and being predominantly Hispanic and Caucasian vs. black non-Hispanic. So far no controls and only 2 subjects have had abnormal aneuploidy screening results and of those that screened positive, 100% have had confirmed postnatal abnormalities. Conclusion: The statistically significant differences observed between groups are likely secondary to the small sample size. To date very few abnormal aneuploidy screening results and no false positives have been observed in either one of the groups. While a larger sample size is required to fully analyze our hypothesis, the results from this study can potentially alter the current aneuploidy screening recommendations in the HIV positive pregnant population. Title: Women with advanced epithelial ovarian cancer requiring gastrostomy tubes for bowel obstruction: The role of best supportive care versus further chemotherapy and parenteral nutrition. Presenter: Erin J. Saks, MD Preceptor: Carolyn McCourt, MD Other Authors: Greg J. Dubel, MD, Vrishali Lopes, MS Objective: To determine the impact of chemotherapy or parenteral nutrition on overall survival, and the proportion of days of life spent in an acute care facility, following gastrostomy tube placement for malignant bowel obstruction from advanced ovarian cancer. Methods: This was a retrospective cohort study. Women treated at Women and Infants Hospital 2005 to 2011 requiring gastrostomy tubes for bowel obstruction due to epithelial ovarian, primary peritoneal or fallopian tube cancer were included. Survival from the time of gastrostomy tube placement was the primary outcome Results: Of the 47 women who met inclusion criteria, 20 had both chemotherapy and TPN, 20 had neither, and 7 had only TPN. There was a documented plan to continue chemotherapy in the 7 women who received only TPN. The cohort was divided into those who received neither chemotherapy nor TPN and those who received one of these treatments. There were no statistically significant differences between the two groups in age (median 63 at time of gastrostomy), time since original diagnosis (median 29 months), and number of previous chemotherapy regimens (median 4), and stage at diagnosis. Median survival from the time of gastrostomy tube placement to death was 29.0 days versus 92.5 days, p 0.006, for the group that received no treatment versus the group that received either chemotherapy or TPN. Percentage of days of life spent in the hospital was 12% for the no treatment group, and 24 % for the either chemotherapy or TPN group, p 0.3. The group that received either chemotherapy or TPN was more likely to die at home, 60% versus 30%, p 0.02. Conclusion: The survival following the need for gastrostomy tube placement for ovarian cancer is poor. There is a role for palliative chemotherapy in the setting of malignant bowel obstruction if the patient’s functional status is adequate to withstand treatment. Title: Interval Surgical Sterilization and Obesity: How does BMI affect complication rates in hysteroscopic versus laparoscopic sterilization? Presenter: Rachel R. Shepherd, MD Preceptor: Rebecca H. Allen, MD, MPH Other authors: Kristen A. Matteson, MD, MPH, Christina A. Raker, ScD, ScM, Nan Du, BMS Objective: To compare the complication rate of hysteroscopic tubal occlusion to interval laparoscopic tubal sterilization across BMI classes Methods:We performed a retrospective cohort study of all women undergoing interval tubal sterilization via laparoscopic approach (LTL) or Essure device between 2007 and December 2011 at Women and Infants Hospital. Data collected included demographics, BMI class, complications, surgical time, recovery time, and estimated blood loss. The chi-square or Fisher’s exact test was used for categorical variables and the T test or Wilcoxon rank-sum test was used for continuous variables. Odds ratios and 95% confidence intervals were used to summarize associations between occlusion type and complications. All p-values presented are two-tailed with p < 0.05 considered statistically significant. Results: A total of 429 charts have been reviewed to date including 282 LTLs and 147 Essures. The LTL group had lower number of co-morbidities (41.8% versus 46.9%, p =0.4) and lower BMI (mean 28.1 versus 29.8, p= 0.04). Surgical time was significantly higher in the LTL group, with the median surgical times being 30 minutes for LTL versus 15 minutes for Essures (p<0.0001). There was no significant difference in major complications with 12 (4.3 %) major complications in the LTL group and 2 (1.4%) in the Essure group (p = 0.2). There was a significant difference in the minor complication rate (LTL n = 74, 26.2% versus Essure n= 25, 17%, p=0.04). Preliminary analysis also indicates that the rate of any complication (major or minor) is higher with a BMI of 30 or higher for LTLs compared to Essure (n = 25, 29.8% versus n = 4, 6.9%, OR 0.17, 95% CI 0.06-0.51) ). Conclusion: While the data collection is not complete, it appears that complication rates are lower with hysteroscopic sterilization especially in patients with a BMI of 30 or higher. Title: Factors associated with treatment failure of global endometrial ablation Presenter: Katelyn Smithling, MD Preceptor: Kristen A. Matteson, MD, MPH Other author: Christina A. Raker, ScD Objective(s): (1) To compare, among women who underwent endometrial ablation for heavy menstrual bleeding, risks of treatment failure and subsequent gynecologic interventions between women with irregular bleeding and women with regular bleeding prior to their procedure and (2) To determine other patient characteristics associated with risk of treatment failure. Methods: We performed a retrospective cohort study of women who underwent endometrial ablation for heavy menstrual bleeding between January 2007 and July 2009. Bleeding pattern was defined as "irregular" or "regular" based on history recorded in notes or the operative report. Treatment failure was defined as reablation or hysterectomy. Subsequent gynecological interventions included endometrial biopsy, dilation and curettage, hysteroscopy, re-ablation, or hysterectomy. Prevalence and odds of treatment failure and subsequent gynecologic intervention were calculated using Chi-square or Fisher's exact test and multiple logistic regression, respectively. Results: Nine hundred sixty-nine women had endometrial ablations for heavy bleeding during the study period. One hundred sixty-nine women were classified as having regular bleeding (17%), 264 had irregular bleeding (27%), and the pattern could not be specified for 474 women (49%). Comparing women with regular and women with irregular bleeding, we found no differences in treatment failure (13% versus 13.4%, p = 1.0) or re-intervention (20.7% versus 22.6%, p = 0.7). When we controlled for confounding variables, women with irregular bleeding were not at increased odds of treatment failure compared to women with regular bleeding [aOR 1.1, (0.6 2.02)]. Women with dysmenorrhea preoperatively had increased odds of treatment failure and re-intervention when compared to women without dysmenorrhea [aOR 3.22 (1.95 – 5.33) and aOR 2.39 (1.53 3.75), respectively]. Similarly, women with previous tubal ligation and women with a higher BMI were at increased odds for treatment failure [aOR 2.05 (1.37 – 3.07) and aOR 1.05 (1.02 1.08), respectively] and re-intervention [aOR 1.69 (1.22 2.33) and aOR 1.05 (1.03 1.07), respectively]. Conclusion: We did not find a difference in failure or intervention rate after endometrial ablation between women with regular and irregular bleeding, however data collection are ongoing. Preoperative dysmenorrhea, tubal ligation, and increased BMI were associated with both failure and gynecologic intervention after endometrial ablation. Title: The effect of topical lidocaine on pain scores during manual vacuum aspiration for nonviable pregnancies Presenter: Amanda M Tower, MD Preceptors: Roxanne A. Vrees, MD and Jared Robins, MD Other author: Vrishali Lopes, MS Objective: To compare pain scores on a visual analogue scale during manual vacuum aspiration for treatment of first trimester nonviable pregnancies between women who are treated with topical lidocaine gel or placebo on the cervix. The hypothesis is that patients treated with topical lidocaine gel will have lower pain scores on a visual analogue scale during intracervical block, tenaculum placement, cervical dilation and aspiration during manual vacuum aspiration for first trimester nonviable pregnancies. Methods: Study design is a double-blinded, randomized, controlled trial. Subjects are women being treated at the Women & Infants Center for Reproduction and Infertility or at the Women and Infants Triage/Women’s Emergency Department who have experienced a first trimester missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and are being treated with a manual vacuum aspiration. They are randomized to receive 9 mL of 2% topical lidocaine gel or 9 mL of placebo gel applied to the cervix prior to the procedure. Measured outcomes are pain scores on a visual analogue scale during tenaculum placement, intracervical block, cervical dilation, and uterine aspiration, as well as demographic information, pertinent medical history, and complications. Assuming an alpha of 0.05, 80% power, and a standard deviation of 21 mm, 32 subjects are required per arm to be able to detect a 15 mm mean difference between groups on the 100 mm visual analogue scale. Results: At this time, 16 patients have been enrolled. The randomized groups do not differ in terms of age, parity, gestational age, history of depression, anxiety or pelvic pain, or preprocedure pain level. Preliminary analysis fails to show any difference in pain scores during MVA between the two groups, but there may be a trend toward less pain during tenaculum placement. Conclusion: More time is needed to complete recruitment before final conclusions can be made, but the results so far do not support use of topical lidocaine to reduce pain during manual vacuum aspiration.