McCall Culdoplasty during Total Laparoscopic Hysterectomy: A Pilot Randomized Controlled Trial
STUDY OBJECTIVE/OBJECTIVE:To assess the feasibility and safety of a McCall culdoplasty at the time of total laparoscopic hysterectomy and to evaluate the differences in the total vaginal length, vaginal apex during Valsalva, and sexual function 12 months after McCall culdoplasty compared with standard cuff closure. DESIGN/METHODS:A pilot randomized controlled, single-masked trial (Canadian Task Force classification I). SETTING/METHODS:An academic tertiary care hospital. PATIENTS/METHODS:Women undergoing total laparoscopic hysterectomy for benign indications from June 2013 to December 2013. INTERVENTIONS/METHODS:Women were randomized (1:1) to McCall culdoplasty followed by standard cuff closure versus standard cuff closure. Patients underwent Pelvic Organ Prolapse Quantification examination and completed the Female Sexual Function Index immediately before surgery and at 6 months and 12 months postoperatively. The primary outcome was the operative time. Secondary outcomes included estimated blood loss, complications, total vaginal length, vaginal apex during Valsalva, and sexual function. MEASUREMENTS AND MAIN RESULTS/RESULTS:This study included 50 patients. The groups were similar in terms of preoperative and surgical characteristics. The operative time did not differ between the groups. The estimated blood loss and complications were also similar. The loss to follow-up was similar in both groups. Changes in the total vaginal length, vaginal apex during Valsalva, sexual function, and pain with intercourse did not differ between the groups. CONCLUSION/CONCLUSIONS:In this pilot study, the addition of McCall culdoplasty to standard cuff closure during total laparoscopic hysterectomy was not associated with an increase in operative time, estimated blood loss, or surgical complications. No differences in the total vaginal length or vaginal apex during Valsalva were observed at the 12-month follow-up. There were no differences in sexual dysfunction or dyspareunia. Given the well-established risk reduction for the development of apical prolapse with McCall culdoplasty during vaginal hysterectomy, this procedure may be a feasible and safe addition to total laparoscopic hysterectomy.
Risk of appendiceal endometriosis among women with deep-infiltrating endometriosis
OBJECTIVE:To determine whether deep-infiltrating endometriosis (DE) carries an increased risk of appendiceal endometriosis (AppE) as compared with superficial endometriosis or no endometriosis. METHODS:In a retrospective study, data were obtained by chart review of an internal database for women who underwent coincidental appendectomy during benign gynecologic surgery between July 2009 and February 2014 at a tertiary referral center in the USA. Univariate, bivariate, and regression analyses were performed. The primary exposure was surgically documented endometriosis (DE, superficial, or no endometriosis). The primary outcome was AppE. RESULTS:Endometriosis was diagnosed for 151 (38.2%) of 395 women; 82 (54.3%) had DE. The prevalence of AppE was 13.2% (52/395) overall; 8 (11.6%) of 69 women with superficial endometriosis and 32 (39.0%) of 82 with DE were affected. Frequency of AppE was increased among women with DE, abnormal appendix appearance, and surgical indication (all P<0.001). Women with DE had a 5.9-fold (95% confidence interval [CI] 2.9-11.9) higher risk of AppE compared with women without endometriosis, controlling for appendiceal appearance and surgical indication, and a 2.7-fold (95% CI 1.2-6.2) higher risk of AppE compared with those with superficial endometriosis. CONCLUSION/CONCLUSIONS:Women with DE have increased risk of AppE. Coincidental appendectomy should form part of complete endometriosis excision for these patients.
Long-Term Safety and Efficacy of Epratuzumab in the Treatment of Moderate-to- Severe Systemic Lupus Erythematosus: Results From an Open-Label Extension Study
OBJECTIVE:The primary objective was to assess the long-term safety of repeated courses of epratuzumab therapy in patients with moderate-to-severe systemic lupus erythematosus. Secondary objectives were to assess long-term efficacy and health-related quality of life (HRQOL). METHODS:Eligible patients from the 12-week, phase IIb, randomized, placebo-controlled EMBLEM study enrolled into the open-label extension (OLE) study, SL0008. In the SL0008 study, patients received 1,200 mg epratuzumab infusions at weeks 0 and 2 of repeating 12-week cycles, plus standard of care. Safety measures included treatment-emergent adverse events (TEAEs) and serious TEAEs. Efficacy measures included combined treatment response, the British Isles Lupus Assessment Group score, the Systemic Lupus Erythematosus Disease Activity Index score, and the physician's and patient's global assessment of disease activity. Total daily corticosteroid dose and HRQOL (by the Short Form 36 health survey) were also assessed. RESULTS:A total of 113 of the 203 patients (55.7%) who entered the SL0008 study continued epratuzumab therapy until study closure (total cumulative exposure: 381.3 patient-years, median exposure: 845 days, and maximum exposure: 1,185 days/approximately 3.2 years). TEAEs were reported in 192 patients (94.6%); most common were infections and infestations (68.0%, 138 patients). Serious TEAEs were reported in 51 patients (25.1%), and 14 patients (6.9%) had serious infections. In patients treated for 108 weeks (nâ€‰=â€‰116), the median corticosteroid dose was reduced from 10.0 mg/day at OLE screening to 5.0 mg/day at week 108. Improvements in efficacy and HRQOL measures in EMBLEM were maintained in the OLE, while placebo patients exhibited similar improvements in disease activity upon a switch to epratuzumab. CONCLUSION/CONCLUSIONS:Open-label epratuzumab treatment was well tolerated for up to 3.2 years, and associated with sustained improvements in disease activity and HRQOL, while steroids were reduced.
Computed Tomography-guided preoperative localization of abdominal wall endometrioma
A multiparous obese patient with prior abdominal surgeries complained of cyclic abdominal pain located near the surgical scar. A 1 cm lesion was identified on imaging. Computed Tomography-guided (CT-guided) needle localization was performed immediately before surgery. This allowed for complete excision of the abdominal wall endometrioma and resolution of the cyclic, focal abdominal pain.
Mechanical bowel preparation before laparoscopic hysterectomy: a randomized controlled trial
OBJECTIVE: To examine the influence of mechanical bowel preparation on surgical field visualization during laparoscopic hysterectomy. METHODS: The study's primary outcome was the percentage of operations rated "good" or "excellent" in terms of surgical field visualization at the outset of the case by the primary surgeon. Additional measures included assessment of visualization during the case and patient perioperative comfort. The study was powered to detect a 20% absolute difference in the proportion of cases rated as "good" or "excellent." RESULTS: Seventy-three patients were assigned to mechanical bowel preparation and 73 to no mechanical bowel preparation. The groups were comparable regarding patient and surgery characteristics. No differences were found for this rating between groups (mechanical bowel preparation, 64 of 73 patients [87.7%], compared with no mechanical bowel preparation, 60 of 73 patients [82.2%], P=.36). Surgeons guessed patient assignment correctly 59% of the time (42 of 71 patients) with mechanical bowel preparation and 55% of the time (41 of 75 patients) with no mechanical bowel preparation. CONCLUSION: Mechanical bowel preparation is well-tolerated but does not influence surgical field visualization for laparoscopic hysterectomy. CLINICAL TRIAL REGISTRATION: ClinialTrials.gov, www.clinicaltrials.gov, NCT01576965.
Short-term effects of salpingectomy during laparoscopic hysterectomy on ovarian reserve: a pilot randomized controlled trial
OBJECTIVE: To examine the short-term effects of salpingectomy during laparoscopic hysterectomy on ovarian reserve when ovarian preservation is planned in view of determining the feasibility of conducting the study on a larger scale. DESIGN: Pilot randomized controlled trial. SETTING: Tertiary care, academic medical center. PATIENT(S): Thirty premenopausal women aged 18 to 45 years undergoing laparoscopic hysterectomy with ovarian preservation for benign indications from April 2012 to September 2012. INTERVENTION(S): Bilateral salpingectomy (n = 15) versus no salpingectomy (n = 15) at the time of laparoscopic hysterectomy with ovarian preservation. MAIN OUTCOME MEASURE(S): Antimullerian hormone (AMH) measured preoperatively, at 4 to 6 weeks postoperatively, and at 3 months postoperatively, with operative time and estimated blood loss abstracted from the medical records. RESULT(S): The mean AMH levels were not statistically significantly different at baseline (2.26 vs. 2.25 ng/ml), 4 to 6 weeks postoperatively (1.03 vs. 1.25 ng/ml), or 3 months postoperatively (1.86 vs. 1.82 ng/ml) among women with salpingectomy versus no salpingectomy, respectively. There was also no statistically significant temporal change in the mean AMH level from baseline to 3 months postoperatively (-0.07 vs. -0.08 ng/ml) between the two groups. No difference in operative time (116 vs. 115 minutes) or estimated blood loss (70 vs. 91 mL) was observed. CONCLUSION(S): Salpingectomy at the time of laparoscopic hysterectomy with ovarian preservation is a safe procedure that does not appear to have any short-term deleterious effects on ovarian reserve, as measured by AMH level. Conducting a trial of this nature that is adequately powered with long-term follow-up evaluation would be feasible and is required to definitively confirm these results.
The accuracy of sonographic imaging interpretation of adnexal masses by specialized versus general sonographers: Implications for the decision making of gynecologic laparoscopists [Meeting Abstract]
Study Objective: To compare the accuracy of histological prediction of adnexal pathology based on the interpretation of sonographic imaging between gynecologists with specialized training in women's health imaging (WHI) and general radiologists (GR) at Bellevue Hospital Center. Design: Retrospective analysis of 237 consecutive cases of adnexal surgery. Setting: University-based tertiary teaching hospital, Department of Obstetrics and Gynecology. Patients: Two hundred thirty seven women (ages 13-81 years) with sonographic diagnosis of adnexal pathology who subsequently underwent surgical intervention. Intervention: Laparoscopy and/or laparotomy. Measurements and Main Results: Of the 237 patients analyzed, 102 (43%) had their pelvic ultrasound performed by WHI and 135 (57%) by GR. Surgical specimens confirmed cancer or low malignant potential lesions in 31 (13%) patients while 206 (87%) had benign pathology. Overall, the positive predictive value (PPV) of ultrasound for identifying cancer was 46.4% and the negative predictive value (NPV) was 91.4%. When the ability to predict malignancy was compared between GR and WHI, the PPV and NPV was 39% versus 80% and 91% versus 92%, respectively. The ultrasound impression "cannot rule out malignancy" was used in 38 (28%) and 6 (6%) of GR and WHI reports, respectively, however, malignancy was found in 19 (14%) of GR and 12 (12%) of WHI groups. Conclusion: Both WHI and GR ultrasound reports have comparable accuracy in terms of prediction of benign adnexal disease. WHI reports appear to have better positive predictive value for the detection of malignancy and contain fewer equivocal conclusions. Gynecologic laparoscopists should be aware of the limitations of ultrasound when relying exclusively on ultrasound imaging for patient counseling and decision making regarding the management of adnexal masses
Maternal-fetal outcomes following trial of labor after cesarean delivery and predictors of success [Meeting Abstract]