Minimally invasive meshless and minimal dissection ligament fixation system for apical organ prolapse procedures: A 4-year prospective follow up study.

OBJECTIVE: EnPlace™ (formerly named NeuGuide™) is a minimally invasive meshless anchoring system for pelvic organ prolapse (POP) repair designed to provide centro-apical pelvic floor support. We present a 4-year prospective follow up evaluation of this repair system. METHODS: This was a single-center longitudinal prospective study of women with advanced POP who underwent pelvic floor apical repair using EnPlace™ with at least 4 years of follow-up. The primary outcome was surgical success defined as anatomical success, no symptoms of vaginal bulging and no need for re-treatment. A standardized validated questionnaire to assess symptom burden was used. RESULTS: Fifteen women were enrolled in the study. Two patients were lost to follow-up. The median follow-up was 51 months (range 42-57) with a surgical success rate of 92.3%. One patient (7.7%) reported symptoms of vaginal vault prolapse and underwent a repeated prolapse surgery. Using the UDI-6 questionnaire, an improvement in all domains was seen. CONCLUSION: The 4-year prospective follow up suggests that apical repair using the EnPlace™ device may be considered safe and effective for sacrospinous ligament fixation with a sustainable long-term success. This procedure is a minimally invasive meshless addition to pelvic surgeon's armamentarium.

[VESICO-VAGINAL FISTULAS (VVF)].

INTRODUCTION: Vesico-vaginal fistula, is a known complication that can occur following damage to the bladder wall during pelvic surgery or prolonged birth. Prompt and accurate diagnosis and timely repair are essential for a quick solution to the problem, and a reduction in medico-legal claims. Successful treatment requires an accurate assessment of the size and the location of the fistula, determination of timing and the surgical technique. There is an approach that advocates postponing the surgery for several months until "tissue healing" subsides and some advocate immediate repair. In our department, the surgery is performed early, immediately upon diagnosis without delay. The aim of the work is to define the clinical manifestation of fistula after surgery, to analyze the factors, and to summarize the experience of an early intervention. METHODS: We reviewed the records of consecutive patients undergoing repair of urogenital fistulas at our institution. Patients with only vesico-vaginal fistulas were included. We recorded demographic characteristics, as well as surgical data, and postoperative complications were also collected. The follow-up period was at least 3 months. RESULTS: A total of 67 women with urogenital fistulas were identified, of whom 37 were only with vesico-vaginal fistulas. Iatrogenic injury, during hysterectomy was the main cause in 70.3%; 2 women were treated conservatively. A repair in the vaginal approach was performed in 31 women, and in 4 women the repair was performed in the abdominal approach, of them, two underwent urethral re-implantation simultaneously. Complications included sepsis in one case, and vaginal cuff dehiscence in another. The success rate of the repair was 92%. Recurrence occurred in 3 patients, of whom 2 had a history of previous radiation. CONCLUSIONS: A vesico-vaginal fistula can be successfully repaired by early repair, without delay, thus saving the patient considerable distress and discomfort.

Enhancing patient mobility following cesarean-delivery - the efficacy of an improved postpartum protocol assessed with pedometers.

BACKGROUND: The incidence of thromboembolic complications is highest in the immediate postpartum period, especially following caesarean delivery (CD). Ambulation following CD is important in their prevention. We examined the effect of an educational protocol on patients' mobility following CD, with the use of digital step counters (pedometers). METHODS: Starting February 2018, we implemented an educational protocol at the maternity ward, which included nurses' tutoring and subsequent patients' education, regarding the importance of early ambulation. Following CD, ambulation was initiated 4 h following surgery (as compared to 6 h prior). Scheduled IV acetaminophen was administered at six-hour intervals for 48 h (as compared to only 24 h prior), while additional analgesics were given upon patient request. We compared maternal demographics, delivery and postpartum course between the pre-protocol group (n = 101) and the post-protocol group (n = 100). All patients were asked to wear pedometers for 48 h following the delivery to assess ambulation. RESULTS: Patients' demographics, surgical and post-partum course were non-significant between the groups, except for surgical length (48.5 ± 14.6 vs. 53.5 ± 15.3 min in the pre and post protocol groups, respectively, p = 0.02). The pre-protocol group was treated with more additional analgesics (p = 0.02). A higher number of steps was taken in the post-protocol group as compared to the pre-protocol group (4394 ± 2985 vs.3551 ± 2931, respectively p = 0.04). In a linear regression analysis in which the number of steps served as the dependent variable, this educational protocol was independently associated with a higher number of steps [coefficient 988 steps, 95% CI 137-1838, p = 0.02], as was smoking, after adjustment for surgical length, emergent surgery, maternal age and body mass index. CONCLUSION: An educational protocol which included earlier ambulation and regular interval pain control was associated with improved ambulation following CD.

Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial.

OBJECTIVE: To assess the effect of a personalized repeated feedback approach using digital step counters (pedometers) on mobility after cesarean delivery in high-risk patients. METHODS: This was a randomized controlled trial at a tertiary university hospital. Patients who underwent cesarean delivery and were defined as high risk for thromboembolic events were asked to wear a pedometer around their wrists postpartum for 48 hours. Patients were randomized to the feedback group, which received personalized feedback by the research staff regarding their mobility at three set timepoints, or the control group, which received standard care. The number of steps taken by patients was compared between the groups and served as the primary outcome. Secondary outcomes included patient reported pain, physical and mental recovery, and overall satisfaction. Sample size was predetermined to detect a 25% between-group difference in the primary outcome. RESULTS: From December 2018 to July 2019, 215 patients were recruited, randomized and completed follow-up-108 in the feedback group and 107 in the control group. Patients' demographics and intrapartum course were similar between the groups. The number of steps taken was significantly higher in the feedback group compared with the control group: 5,918±3,116 vs 4,161±2,532 steps, P<.001. Pain scores were similar between the groups, as was analgesic consumption. Patients in the feedback group reported a significantly easier physical and mental postpartum recovery and were significantly more satisfied with their delivery experience. Postpartum complications did not differ between the groups. CONCLUSION: In high-risk patients after cesarean delivery, mobility was improved by using a personalized feedback approach. Enhanced mobility was not associated with a higher rate of complications or pain and was positively associated with patient satisfaction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03724760.

Comparison of 3 protocols for analgesia control after cesarean delivery: a randomized controlled trial.

BACKGROUND: Proper pain control after cesarean delivery is of high clinical importance to the recovery and relief of patients after surgical delivery. OBJECTIVE: We aimed to compare fixed time interval to on-demand regimens of nonopioid analgesics and to assess whether a protocol that is based on intravenous administration is superior to oral administration. STUDY DESIGN: This was a randomized controlled trial performed between April 2017 and May 2018. Patients who underwent elective cesarean delivery were assigned randomly to receive 1 of 3 pain relief protocols for the first 48 hours after surgery: (1) the fixed intravenous protocol included intravenous paracetamol (acetaminophen) 3 times daily with oral ibuprofen twice daily, (2) the fixed oral protocol included oral paracetamol 3 times daily with oral ibuprofen twice daily; if the patient requested additional analgesia, tramadol hydrochloride or dipyrone were given as rescue treatments, (3) the on-demand protocol included oral paracetamol or ibuprofen or dipyrone (based on visual analog scale). Pain intensity was measured and compared with the use of the visual analog scale (range, 0 ([no pain] to 10 [worst pain]). Total doses of pain relief analgesia and maternal and neonatal adverse effects were compared between the groups. RESULTS: The study included 127 women who were assigned randomly to the intravenous protocol group (n=41), oral protocol group (n=43), and on-demand protocol group (n=43). There were no between group differences in maternal and pregnancy characteristics, cesarean delivery indications, or surgical technique. The average visual analog scale score was 6.2±0.8 in the intravenous group, 7.0±1.1 in the oral group, and 7.5±0.7 in the on-demand group, in the first 24 hours (P=.01) and 6.4±0.7, 6.8±0.9, and 7.4±0.7 for the total 48 hours, respectively (P<.001). Mean pain score reduction was higher in the intravenous protocol compared with the fixed oral protocol group (4.7±1.2 vs 4.0±1.4; P=.02). The median doses of pain relief analgesia in the intravenous group were 5 (interquartile range, 5-7), 6 in the oral group (interquartile range, 4-6), and 4 in the on-demand group (interquartile range, 3-6; P=.001) in the first 24 hours and 9 (interquartile range, 7-10), 9 (interquartile range, 7-10), and 7 (interquartile range, 4-9), respectively, for the total 48 hours (P<.001). There were no "between group" differences in neonatal birthweight or maternal and neonatal adverse outcomes. CONCLUSION: Administration of pain relief analgesia (ibuprofen and acetaminophen) in fixed time intervals (intravenous or oral) after cesarean delivery yielded reduced visual analog scale pain scores compared with an on-demand protocol, despite fewer pain relief drugs consumed in the on-demand group.

Pregnancies Following Hysteroscopic Removal of Retained Products of Conception after Delivery Versus Abortion.

AIM: To compare clinical variables, sonographic findings and pregnancy outcomes following the hysteroscopic removal of retained products of conception (RPOC) after delivery and abortion. METHODS: This is a retrospective cohort of operative hysteroscopies performed between 2011 and 2015 for suspected RPOC, during which trophoblastic tissue was obtained. Patient demographics, clinical presentation, sonographic evaluation, subsequent infertility and pregnancy outcomes were compared between post-delivery (n = 85) and post-abortion (n = 93) cases. RESULTS: The main presenting symptom in both study groups was vaginal bleeding. On sonographic evaluation, maximal endometrial thickness was significantly higher in the post-delivery group, while irregularity and increased flow were more common in the post-abortion group. There was a similar rate of deliveries following hysteroscopy in both groups with 40% in the post-delivery group and 39.7% in the post-abortion group. Deliveries in the post-delivery group were characterized by a higher rate of abnormal placentation - 30.5% - including low lying placenta and placenta accreta. A significant rate of vaginal deliveries in both groups entailed manual removal of the placenta or exploration of the uterine cavity (23.5 and 10.5%, p = 0.20). CONCLUSION: Pregnancies following RPOC after delivery entail a higher rate of abnormal placentation.

Is There a Difference in the Outcome of Mid-Urethral Sling Operations Performed by Urogynecologists Compared with Supervised Residents?

STUDY OBJECTIVE: To compare the operative results of midurethral sling (MUS) surgeries for stress urinary incontinence (SUI) performed by residents under the guidance of an attending specialist in urogynecology and those performed by attendings. DESIGN: Retrospective chart review (Canadian Task Force classification II-2). SETTING: University hospital. PATIENTS: A retrospective analysis of all MUS surgeries performed at a single public tertiary medical center between January 2009 and December 2013 was carried out. A total of 257 patients underwent transobturator tape (TOT) placement during the study period, including 136 (52.9%) placed by an attending specialist in urogynecology (group A) and 121 (47.1%) placed by a resident, under the guidance of an attending (group B). MEASUREMENTS: The efficacy of treatment was evaluated in terms of early postoperative course, reoperation, and symptom improvement, as based on the Pelvic Floor Distress Inventory short form (PFDI-20) questionnaire. The primary outcome was patient-reported symptoms of SUI, as assessed with the PFDI-20 questionnaire, as well as absence of surgical retreatment for SUI. RESULTS: Immediate postoperative complications were comparable in the 2 groups, as were subjective failure and self-reported SUI. The primary outcome-moderate and severe symptoms of SUI-were reported by 23.7% of the patients in group A and 23.6% of those in group B (p = .91). At a mean follow-up of 40 months in both groups, symptoms, as assessed using the urinary scale and prolapse scale of the PFDI-20, were also similar in the 2 groups. The rate of reoperation with repeated sling for SUI was 5% in both groups. CONCLUSION: The operative results of TOT surgery for SUI performed by residents under the guidance of an attending specialist in urogynecology did not differ significantly from those performed by the attendings themselves.

Safety and short term outcomes of a new truly minimallyinvasive mesh-less and dissection-less anchoring system for pelvic organ prolapse apical repair.

OBJECTIVE: To evaluate the safety and short term outcomes of a new, truly minimallyinvasive, mesh-less and dissection-less anchoring system for pelvic floor apical repair. METHODS: A prospective study was conducted using the NeuGuide™ device system for pelvic floor apical repair. The primary effectiveness outcome was centro-apical pelvic floor prolapse by POP-Q after six months. The primary safety outcome was intra-operative, immediate (first 48 h) post-operative complications and adverse effects after six months. A standardized questionnaire (UDI-6) to assess quality of life at entry and during follow-up visits was used. Patients' six months-follow-up and evaluation are reported. RESULTS: The mean age of the study population (n=10) was 63.8±12.0 years. All patients had a previous prolapse surgery. Five had a previous hysterectomy and two had stress urinary incontinence symptoms. During surgery six patients had a concurrent colporrhaphy. There was no injury to the bladder, rectum, pudendal nerves, or major pelvic vessels and no febrile morbidity was recorded. At six months, no cases of centro-apical recurrence were noted. Patients were satisfied with the procedure and had favorable quality of life scores. Using the UDI-6 questionnaire an improvement, in all domains was seen. Moreover, although the sample size was small, the improvement in urge and overflow incontinence related domains were demonstrated to be statistically significant. CONCLUSIONS: This new NeuGuide™ device allows rapid and safe introduction of a suspending suture through the sacrospinous ligament and makes sacrospinous ligament fixation easy to perform, while avoiding dissection and mesh complications.

Gemcitabine-Induced Subacute Cutaneous Lupus Erythematosus: A Case Report.

Subacute cutaneous lupus erythematosus (SCLE) is a rare eruption related to several pharmacological and chemotherapy agents. We present a 63-year-old female with recurrent epithelial ovarian cancer who developed SCLE after administration of gemcitabine. Following discontinuation of gemcitabine and after oral steroid treatment, all skin lesions disappeared. In view of the extensive use of gemcitabine in recurrent ovarian cancer, it is important to be aware of the possibility of SCLE occurrence in these patients.