Wetzstein, Marnie M.

Background: Ovarian cancer has the highest mortality of all gynecologic malignancies, howeverthere is no proven effective screening for ovarian cancer. Evidence suggests that epithelial ovarian cancer begins in the fallopian tubes. Prophylactic bilateral total salpingectomy has been shown to reduce the risk of epithelial ovarian cancer and is now recommended to be considered at the time of sterilization procedures. There are limited well designed clinical trials that compare the safety and feasibility of total salpingectomy to that of traditional partial salpingectomy for tubal sterilization in obstetrics. We thus conducted a randomized controlled trial to assess the safety of bilateral total salpingectomy at the time of cesarean delivery. Methods: We conducted a non-inferiority randomized controlled trial at the Mayo Clinic, Rochester, Minnesota. Women age 21 years and older who were undergoing cesarean delivery and desired concomitant sterilization were enrolled between May 17, 2017 and July 16, 2018. Stratified randomization was performed based on number of previous cesarean deliveries and their Basal Metabolic Index, into a bilateral total salpingectomy (BTS) group and bilateral partial salpingectomy (BPS) group. All salpingectomies were performed using clamps and suture. The primary outcome was to compare the mean peri-operative hemoglobin change for both groups. Secondary objectives included sterilization completion time, postoperative length of stay, estimated blood loss, postoperative pain and adverse events. Results: Of the 111 women screened, 40 were enrolled and randomized. Of these, 38 underwent the assigned procedure (18 BTS, 20 BPS). No difference in Mean ± SD hemoglobin drop between groups (1.4 ± 0.7 g/dL for the BPS group and 1.8 ± 1.0 g/dL for the BTS group, p = 0.08), however the point estimate of –0.4 is very close to the non-inferiority margin of –0.5, and the CI widely exceeds the non-inferiority margin (95% CI –0.99, 0.17). Therefore non-inferiority was not shown. Mean time to completion of sterilization procedure was significantly longer in the BTS group (16.3 ± 5.6 minutes for the BTS group vs 5.1 ± 1.6 minutes for the BPS group, p < 0.01). No significant differences for other outcome measures. Conclusions: Bilateral total salpingectomy is not non-inferior to tradiational bilateral partial salpingectomy with regards to postoperative hemoglobin drop, and is associated with a small increase in operative time. There, however, was no difference in adverse events, postoperative length of stay and postoperative pain between the two groups. This information may be helpful when counseling patients.

Abstract BACKGROUND: It is estimated that one third of women in the United States opt for permanent tubal sterilization at the time of cesarean delivery. Evidence suggests that ovarian cancer begins in the fallopian tubes. Ovarian cancer has the highest mortality of all gynecologic malignancies. There is no proven effective screening for ovarian cancer. In view of this, the Royal College of Obstetricians & Gynecologists and the American College of Obstetricians and Gynecologists recommend considering counseling patients about prophylactic salpingectomy as an effective method of sterilization. There are limited well designed clinical trials that compare the safety and feasibility of total salpingectomy to that of traditional partial salpingectomy for tubal sterilization at the time of cesarean delivery. METHODS: We conducted a non-inferiority randomized controlled trial at the Mayo Clinic, Rochester, Minnesota. Women age 21 years and older who were undergoing cesarean delivery and desired concomitant sterilization were enrolled between May 17, 2017 and July 16, 2018. Stratified randomization was performed based on number of previous cesarean deliveries and their Basal Metabolic Index, into a bilateral total salpingectomy group and bilateral partial salpingectomy group. All salpingectomies were performed using clamps and suture. The primary outcome was to compare the mean peri-operative hemoglobin change for both groups. Secondary objectives included sterilization completion time, postoperative length of stay, estimated blood loss, postoperative pain and adverse events. RESULTS: Of the 111 women screened, 40 were enrolled and randomized. Of these, 38 underwent the assigned procedure (18 BTS, 20 BPS). There were no demographic differences between groups. No difference in Mean ±SD hemoglobin drop between groups (1.4±0.7 g/dl for the BTS group and 1.8±1.0 g/dl for the BPS group, p=0.08). Mean time to completion of sterilization procedure was significantly longer in the BTS group (16.3±5.6 minutes for the BTS group vs 5.1±1.6 minutes for the BPS group, p < .01). No significant differences for other outcome measures.CONCLUSIONS: Bilateral total salpingectomy at the time of cesarean delivery does not increase the risk for blood loss and has similar peri-operative outcomes, with a small increase in operative time when compared to traditional bilateral partial salpingectomy. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03135431, 27/04/2017

Pulmonary rehabilitation (PR), following an acute exacerbation of chronic obstructive pulmonary disease (COPD), has been found effective in some studies in reducing readmission rates as and has recently been recommended by the PR guidelines. However, very recent reports suggested that PR is not feasible after a hospital admission for a COPD exacerbation. The objective of this study is to investigate the knowledge gap on the underlying reasons for nonparticipation in PR in the posthospitalization period. We qualitatively analyzed the responses of 531 patients hospitalized for a COPD exacerbation who were not interested in participating in either PR (home or center based) or physical activity monitoring program after being discharged from the hospital. The responses were coded thematically, and independent reviewers compiled the raw data into themes. The characteristics of the 531 subjects (45% male) who declined the intervention are as follows: age was 70 ± 10 years, mean forced expiratory volume in one second (FEV1%) predicted 40 ± 16, and age, dyspnea, and airflow obstruction index 6.0 ± 1.6 (scale 0–10). The themes for not attending include lack of interest (39%), the perception of “being too ill or frail or disabled” (24%), the perception of being “too busy or having too much to do” (11%), distance or the need of travel (11%), commitment issues (7%), comorbidities (6%), and lack of social support (2%). We identified barriers for PR or just physical activity programs after a hospitalization that may affect implementation of such programs. Implementing posthospitalizations program in COPD may require patient engagement and mindful and compassionate professionals who may individualize program components to focus specific deficits and particularly patients’ preferences.