Technicity in Canada: A Nationwide Whole-Population Analysis of Temporal Trends and Variation in Minimally Invasive Hysterectomies.

STUDY OBJECTIVE: The objective of our study was to provide a contemporary description of hysterectomy practice and temporal trends in Canada. DESIGN: A national whole-population retrospective analysis of data from the Canadian Institute for Health Information. SETTING: Canada. PATIENTS: All women who underwent hysterectomy for benign indication from April 1, 2007, to March 31, 2017, in Canada. INTERVENTIONS: Hysterectomy. MEASUREMENTS AND MAIN RESULTS: A total of 369 520 hysterectomies were performed in Canada during the 10-year period, during which the hysterectomy rate decreased from 313 to 243 per 100 000 women. The proportion of abdominal hysterectomies decreased (59.5% to 36.9%), laparoscopic hysterectomies increased (10.8% to 38.6%), and vaginal hysterectomies decreased (29.7% to 24.5%), whereas the national technicity index increased from 40.5% to 63.1% (p <.001, all trends). The median length of stay decreased from 3 (interquartile range 2-4) days to 2 (interquartile range 1-3), and the proportion of patients discharged within 24 hours increased from 2.1% to 7.2%. In year 2016-17, women aged 40 to 49 years had significantly increased risk of abdominal hysterectomy compared with women undergoing hysterectomy in other age categories (p <.001). Comparing women with menstrual bleeding disorders, women undergoing hysterectomy for endometriosis (adjusted relative risk [aRR] 1.36; 95% confidence interval [CI], 1.28-1.44) and myomas (aRR 2.01; 95% CI, 1.94-2.08) were at increased risk of abdominal hysterectomy, whereas women undergoing hysterectomy for pelvic organ prolapse and pelvic pain (aRR 1.47; 95% CI, 1.41-1.53) were at decreased risk. Using Ontario as the comparator, Nova Scotia (aRR 1.35; 95% CI, 1.27-1.43), New Brunswick (aRR 1.25; 95% CI, 1.18-1.32]), Manitoba (aRR 1.35; 95% CI, 1.28-1.43), and Newfoundland and Labrador (aRR 1.18; 95% CI, 1.10-1.27) had significantly higher risks of abdominal hysterectomy. In contrast, Saskatchewan (aRR 0.75; 95% CI, 0.74-0.77) and British Columbia (aRR 0.86; 95% CI, 0.85-0.88) had significantly lower risks, whereas Prince Edward Island, Quebec, and Alberta were not significantly different. CONCLUSION: The proportion of minimally invasive hysterectomies for benign indication has increased significantly in Canada. The declining use of vaginal approaches and the variation among provinces are of concern and necessitate further study.

Case Series of Reproductive Outcomes after Laparoscopic Radiofrequency Ablation of Symptomatic Myomas.

STUDY OBJECTIVE: To analyze pregnancy delivery and safety outcomes after patient receipt of percutaneous, laparoscopic intra-abdominal ultrasound-guided radiofrequency ablation (Lap-RFA) for symptomatic uterine myomas. DESIGN: Case series (2010-2017); evidence was obtained from 2 randomized, controlled trials (level I), 6 cohort studies (level II-2), and in commercial settings (level II-3). SETTING: Multiple sites in the United States, Canada, Europe, and Latin America (university hospitals, community hospitals, and stand-alone surgery centers). Commercial cases were United States based and followed US Food and Drug Administration clearance of Lap-RFA. PATIENTS: Premenopausal adult women with symptomatic uterine myoma types 1 through 6. INTERVENTIONS: The Lap-RFA procedure was conducted under general anesthesia with laparoscopic and intra-abdominal ultrasound guidance. MEASUREMENTS AND MAIN RESULTS: Safety unknowns included the safety of a full-term pregnancy for mother and baby, rates of spontaneous abortion, preterm delivery, postpartum hemorrhage, placental abnormalities, intrauterine growth restriction, and vaginal versus cesarean delivery. A total of 28 women (mean age = 35.0 ± 3.4 years) conceived a total of 30 times after Lap-RFA, either as part of a clinical study or in commercial settings. The number of myomas treated per patient ranged from 1 to 7. The diameter of treated myomas ranged from 0.9 to 11.0 cm. Most patients had 1 or 2 myomas, and most myomas were ≤5.5 cm in maximal diameter. The 30 pregnancies resulted in 26 full-term live births (86.7%), all healthy infants, with an equal distribution of vaginal and cesarean deliveries. Four (13.3%) spontaneous abortions occurred. No cases of preterm delivery, uterine rupture, placental abruption, placenta accreta, or intrauterine growth restriction were reported. One event each of placenta previa and postpartum hemorrhage were reported. CONCLUSION: Conception and safe, full-term pregnancy are achievable after Lap-RFA of symptomatic myomas. Additional large, rigorous, multivariate prospective studies that adjust for confounders and report pregnancy outcomes after symptomatic myoma treatment are needed.

Clinical outcomes and health care utilization pre- and post-laparoscopic radiofrequency ablation of symptomatic fibroids and laparoscopic myomectomy: a randomized trial of uterine-sparing techniques (TRUST) in Canada.

OBJECTIVE: The objective of this study was to compare laparoscopic ultrasound-guided radiofrequency ablation of fibroids (Lap-RFA) and laparoscopic myomectomy in terms of 1) health care utilization and 2) serious complication rates. The secondary objectives were comparison of subject responses to validated symptom and quality-of-life questionnaires. We hypothesized that Lap-RFA health care utilization and clinical outcomes would not be worse than those of laparoscopic myomectomy in the aggregate. PATIENTS AND METHODS: Post-market, randomized, prospective, multicenter, longitudinal, non-inferiority interventional comparative evaluation of health care utilization and clinical outcomes in premenopausal women with symptomatic uterine fibroids who desired uterine conservation was conducted. Both procedures were planned as outpatient day surgeries. Health care resource utilization was measured during the procedure day and at 1 week, 1 and 3 months post-surgery. Symptom severity and quality of life were based on patients' responses to the Uterine Fibroid Symptom Severity and Quality-of-Life Questionnaire, EuroQol-5D-visual analog scale general health status and menstrual impact questionnaires, and time from work. RESULTS: Forty-five participants provided written informed consent and were enrolled (Lap-RFA, n=23; myomectomy, n=22) in Canada. Hospitalization time (primary endpoint) was 6.7±3.0 hours for the Lap-RFA group and 9.9±10.7 hours for the myomectomy group (Wilcoxon, p=0.0004). Intraoperative blood loss was lesser for Lap-RFA subjects: 25.2±21.6 versus 82.4±62.5 mL (p=0.0002). Lap-RFA procedures took lesser time than myomectomy procedures: 70.0 versus 86.5 minutes (p=0.018), and Lap-RFA required -34.9% (130 fewer) units of surgical equipment. At 3 months, both cohorts reported the same significant symptom severity reduction (-44.8%; p<0.0001). Lap-RFA subjects also took lesser time from work: 11.1±7.6 versus 18.5±10.6 days (p=0.0193). One myomectomy subject was hospitalized overnight after experiencing a 20-second asystole during the procedure. One Lap-RFA subject underwent a reintervention. The combined per patient direct and indirect costs of the two procedures were comparable: Lap-RFA (CAD $5,224.96) and myomectomy (CAD $5,321.96). CONCLUSION: Compared to myomectomy, Lap-RFA is associated with significantly lesser intraoperative blood loss, shorter procedure and hospitalization times, lesser consumption/use of disposable and reusable surgery equipment, reduced health care resource utilization, and faster return to work through 3 months posttreatment. Direct and indirect costs of Lap-RFA and myomectomy are comparable.

Essure microinsert imaging: does abnormal shape on ultrasound predict complications on HSG?

OBJECTIVE: We hypothesize that the shape of the Essure microinsert on ultrasound is able to predict complications evident on hysterosalpingogram (HSG), the accepted gold standard. METHOD AND MATERIALS: From July 2, 2009 to July 2, 2012, 441 women at our institution received Essure microinsert placement for the purpose of permanent sterilization. 2D and 3D coronal plane transvaginal ultrasounds were performed three months after Essure microinsert placement. Those patients with complications identified on ultrasound, a non-diagnostic ultrasound, or following a difficult insertion were referred for HSG. Patients with both HSG and ultrasound performed were retrospectively selected and anonymized. The ultrasounds were reviewed by a single, blinded radiologist. A total of 122 microinserts in 65 patients were described on ultrasound using a numeric grading system and compared to HSG findings. RESULTS: Microinsert placement resulted in 37 complications, 31 of which were identified on ultrasound, including uterine and tubal perforations and placement in the endometrial cavity. The sensitivity of Essure microinsert shape on ultrasound in predicting complications, compared with standard HSG, was 94%, with a positive predictive value of 85%; specificity was 95%, with a negative predictive value of 98%. The Kappa coefficient was 0.85 (p < 0.001). CONCLUSION: Our results suggest that ultrasound may be used as a frontline imaging modality for patients after Essure microinsert placement.

Evaluation of the NovaSure endometrial ablation procedure in women with uterine cavity length over 10 cm.

OBJECTIVE: To evaluate procedure-related adverse events, post-procedure menstrual bleeding status, and surgical re-intervention in women with a sounded uterine length > 10 cm compared to women with a sounded uterine length ≤ 10 cm who underwent the NovaSure endometrial ablation procedure. METHODS: We conducted a retrospective cohort study of 188 women from a Canadian community-based gynaecology practice. Eighty-seven women had a sounded uterine length > 10 cm, and 101 patients had a sounded length ≤ 10 cm. Procedure-related adverse events, post-procedure menstrual bleeding status, and surgical re-interventions were compared between groups. RESULTS: Mean uterine sounding lengths were 11.0 ± 0.6 cm and 8.9 ± 0.8 cm in the > 10 cm and ≤ 10 cm groups, respectively. There were no differences between the groups in demographic characteristics or gynaecologic history, with the exception of higher BMI in the > 10 cm group and a greater prevalence of dysmenorrhea in the ≤ 10 cm group. Overall, 44.1% of all participants had been unsuccessfully treated with hormonal therapy, and 20.7% had failed non-hormonal treatment before the ablation procedure. The remaining 35.2% of participants had declined alternative therapy and proceeded directly to endometrial ablation. No serious procedure-related adverse events occurred in either group. Menstrual bleeding status at follow-up at 30.4 ± 15.3 months (> 10 cm group) and 30.5 ± 15.5 months (≤ 10 cm group) was not different between the groups (P = 0.85). In women who did not undergo surgical re-intervention after the initial ablation, amenorrhea was reported by 51.9% in the > 10 cm group and 65.9% in the ≤ 10 cm group. CONCLUSION: The NovaSure endometrial ablation procedure was associated with successful menstrual bleeding outcomes in women with sounded uterine length > 10 cm. No serious procedure-related adverse events occurred, and the need for surgical re-intervention was low. There was no significant difference in bleeding rates between the > 10 cm and ≤ 10 cm uterine length cohorts.

Objectif : Comparer, chez des femmes ayant subi une ablation de l'endomètre au moyen de la technique NovaSure et présentant une longueur utérine déterminée par hystérométrie de plus de 10 cm ou de 10 cm ou moins, les événements indésirables associés à l'intervention, l'état des saignements menstruels à la suite de l'intervention et la nécessité de procéder à une nouvelle intervention chirurgicale. Méthodes : Nous avons mené une étude de cohorte rétrospective qui portait sur 188 femmes ayant fréquenté une pratique gynécologique communautaire au Canada. Quatre-vingt-sept de ces femmes présentaient une longueur utérine déterminée par hystérométrie de plus de 10 cm, tandis que les 101 autres présentaient une longueur utérine déterminée par hystérométrie de 10 cm ou moins. Les événements indésirables associés à l'intervention, l'état des saignements menstruels à la suite de l'intervention et la nécessité de procéder à une nouvelle intervention chirurgicale sont les paramètres qui ont été comparés chez ces deux groupes de femmes. Résultats : Les longueurs utérines moyennes déterminées par hystérométrie ont été de 11,0 ± 0,6 cm et de 8,9 ± 0,8 cm au sein des groupes « > 10 cm ¼ et « ≤ 10 cm ¼, respectivement. Aucune différence n'a été constatée entre les groupes en matière de caractéristiques démographiques ou d'antécédents gynécologiques, exception faite d'un IMC accru au sein du groupe « > 10 cm ¼ et d'une prévalence accrue de dysménorrhée au sein du groupe « ≤ 10 cm ¼. De façon globale, 44,1 % de toutes les participantes avaient connu l'échec de l'hormonothérapie et 20,7 % avaient connu l'échec d'un traitement non hormonal avant la tenue de l'ablation. Les participantes composant les autres 35,2 % avaient refusé d'avoir recours à un traitement de rechange et décidé de subir directement une ablation de l'endomètre. Aucun événement indésirable grave associé à l'intervention ne s'est manifesté dans l'un ou l'autre des groupes. Aucune différence n'a été constatée entre les groupes (P = 0,85) pour ce qui est de l'état des saignements menstruels au moment du suivi à 30,4 ± 15,3 mois (groupe « > 10 cm ¼) et à 30,5 ± 15,5 mois (groupe « ≤ 10 cm ¼). Chez les femmes qui n'ont pas eu à subir une nouvelle intervention chirurgicale à la suite de l'ablation initiale, une aménorrhée a été signalée par 51,9 % des participantes du groupe « > 10 cm ¼ et par 65,9 % des participantes du groupe « ≤ 10 cm ¼. Conclusion : La technique NovaSure d'ablation de l'endomètre a été associée à des issues réussies en matière de saignements menstruels chez les femmes présentant une longueur utérine déterminée par hystérométrie de plus de 10 cm. Aucun événement indésirable grave associé à l'intervention ne s'est manifesté et la nécessité de procéder à une nouvelle intervention chirurgicale était faible. Aucune différence significative n'a été constatée en matière de taux de saignement entre les groupes « > 10 cm ¼ et « ≤ 10 cm ¼.

Concomitant NovaSure endometrial ablation and Essure tubal sterilization: a review of 100 cases.

OBJECTIVE: To assess the success rate, complications, and technical difficulties of concomitant NovaSure radiofrequency global endometrial ablation (NS-GEA) and Essure hysteroscopic sterilization (EHS). METHODS: We conducted a retrospective descriptive study of 100 women undergoing concomitant NS-GEA and EHS for abnormal uterine bleeding. The combined procedure was completed using conscious sedation, in an outpatient setting. Patients were asked to return three months post procedure to have proper micro-insert positioning confirmed by hysterosalpingogram, ultrasound, and/or pelvic radiograph. RESULTS: An average of five micro-inserts were left trailing into the endometrial cavity. The mean duration of the procedure was on average 17.1 minutes. Eighty-seven patients returned for follow-up. The combined procedure was successful in 80 of these 87 patients (92%) and not successful in seven patients (8%). To improve visualization of the tubal ostia, 25 patients had suction curettage after NS-GEA, with no significant increase in the procedure time (P = 0.927). Technical difficulties included impaired visualization of the tubal ostia (7.4%), difficulty in visualizing or counting micro-inserts after placement (3.2%), and resistance to micro-insert placement (3.2%). The procedure complications were intrauterine synechiae (5.7%), endometritis (2.3%), pain that required an emergency room visit (2.3%), and migration of micro-inserts with or without perforation (4.6%). CONCLUSION: Concomitant NS-GEA and EHS is a safe and efficient method of providing treatment for abnormal uterine bleeding and permanent female sterilization. The combined procedure can be safely moved from the operating theatre to an outpatient setting, completely independent of anaesthesia and day surgery services. Suction curettage should be considered before EHS. A small proportion of patients may develop post-procedure intrauterine synechiae that impaired the ability to document tubal occlusion by hysterosalpingogram.

Oral analgesia vs intravenous conscious sedation during Essure Micro-Insert sterilization procedure: randomized, double-blind, controlled trial.

STUDY OBJECTIVE: To compare the pain reported by patients during the Essure Micro-Insert sterilization procedure using either intravenous conscious sedation or oral analgesia. DESIGN: Randomized, double-blind, placebo-controlled trial (Canadian Task Force classification I). SETTING: Tertiary care ambulatory women's clinic. PATIENTS: Eighty women of reproductive age women requesting permanent sterilization. INTERVENTION: Hysteroscopic placement of the Essure Micro-Insert permanent birth control system. MEASUREMENTS AND MAIN RESULTS: Patients undergoing placement of the Essure Micro-Insert system for permanent contraception were randomized to receive either intravenous conscious sedation, oral analgesia, or placebo. During the procedure, pain scores were recorded using a visual analog scale. Patients in the oral analgesia group reported slightly more pain during insertion of the hysteroscope and placement of the second micro-insert; the groups were otherwise equivalent. They were also equivalent when all visual analog scale scores were combined. CONCLUSION: Oral analgesia is an effective method of pain control during placement of the Essure Micro-Insert permanent birth control system.

Cost-effectiveness analysis comparing the essure tubal sterilization procedure and laparoscopic tubal sterilization.

OBJECTIVE: To analyze the financial implications of establishing a hysteroscopic sterilization program using the Essure micro-insert tubal sterilization system in an ambulatory clinic. METHODS: A retrospective cohort study (Canadian Task Force classification Type II-2), in an ambulatory women's health clinic in a tertiary hospital, of 108 women undergoing Essure coil insertion between 2005 and 2006, and 104 women undergoing laparoscopic tubal sterilization for permanent sterilization between 2001 and 2004. The Essure procedures used a 4 mm single channel operative hysteroscope and conscious sedation (fentanyl and midazolam); the laparoscopic tubal sterilizations were completed under general anaesthesia with a 7 mm laparoscope and either bipolar cautery or Filshie clips. Costs associated with the procedure, follow-up, and management of any complications (including nursing, hospital charges, equipment, and disposables) were tabulated. RESULTS: The Essure coils were successfully placed on the first attempt in 103 of 108 women (95%). Three patients required a second attempt to complete placement and two patients required laparoscopic tubal sterilization after an unsuccessful Essure. All 104 laparoscopic tubals were completed on the first attempt with no complications reported. The total cost for the 108 Essure procedures, including follow-up evaluation, was $138,996 or $1287 per case. The total cost associated with the 104 laparoscopic tubal sterilization procedures was $148,227 or $1398 per case. The incremental cost-effectiveness ratio was $111. CONCLUSIONS: The Essure procedure in an ambulatory setting resulted in a statistically significant cost saving of $111 per sterilization procedure. Carrying out the Essure procedure in an ambulatory setting frees space in the operating room for other types of cases, improving access to care for more patients.

Pentoxifylline after conservative surgery for endometriosis: a randomized, controlled trial.

STUDY OBJECTIVE: To compare outcomes after conservative surgery for endometriosis with and without pentoxifylline and to assess the efficacy of pentoxifylline in preventing recurrence of endometriosis after conservative surgery. DESIGN: Parallel-group, randomized, controlled trial (Canadian Task Force classification I). SETTING: Tertiary care hospital. PATIENTS: Women undergoing conservative surgery for endometriosis. INTERVENTIONS: Laparoscopic conservative surgery for endometriosis was completed by a single surgeon (J.A.T.), and all suspected endometriotic lesions were widely excised using monopolar coagulation and scissors. All specimens were submitted to pathology for confirmation of the diagnosis. Randomization to the treatment or control groups was completed preoperatively in the outpatient surgery unit by drawing colored marbles. A preoperative visual analog pain scale (VAS) was completed. After surgery, patients were discharged home with prescriptions for naproxen, hydromorphone, and pentoxifylline. MEASUREMENTS AND MAIN RESULTS: Visual analog scale scoring was completed monthly by each patient, and each patient was seen monthly for review and pelvic examination. Analgesic use was recorded daily using an individual medication log. Ongoing treatment choice after completion of the 3-month follow-up was recorded. The relationship between the group receiving pentoxifylline and the control group as well as analysis of the VAS scores at time of surgery and 1, 2, and 3 months postoperatively was determined using a covariate mixed-model ANOVA. Forty-nine patients were enrolled in the trial. One patient became pregnant before surgery, and 1 patient's chart was not available for analysis. Of the 47 who underwent conservative surgery for endometriosis, 9 (19%) had no endometriosis noted in the pathology specimens submitted. Two patients withdrew from the trial after surgery, and 2 patients were lost to follow-up after relocating to a different city. Nineteen women completed the 3-month follow-up in the control group, 15 in the group receiving pentoxifylline. The mean age, gravidity, parity, body mass index, previous surgery for endometriosis, menstrual cycle, and preoperative analgesic use did not differ significantly between the control and treatment groups. The time to complete the conservative surgery did not vary between the 2 groups. There were no intraoperative complications: two patients were admitted postoperatively, one for nausea and vomiting, one for pain that resolved 24 hours after admission. The VAS scores did not differ at the time of surgery; and in both the control and the pentoxifylline groups, there was significant improvement at each monthly interval (p <.05). The patients receiving pentoxifylline had significantly better VAS scores at 2 and 3 months after surgery (p <.03). CONCLUSIONS: The use of pentoxifylline after conservative surgery for endometriosis resulted in improved VAS scores at 2 and 3 months after the procedure when compared with patients having conservative surgery only. The longer-term use of pentoxifylline after conservative surgery may improve long-term outcomes after surgical treatment for endometriosis.

Assessment of costs associated with outpatient total laparoscopic hysterectom.

OBJECTIVE: To assess the costs associated with the performance of outpatient total laparoscopic hysterectomy. METHODS: This was a retrospective cohort study involving 224 consecutive patients undergoing total laparoscopic hysterectomy (TLH) by a single surgeon in the Regina General Hospital. Outcomes included costs associated with the initial procedure as well as those associated with any intraoperative or postoperative complications. RESULTS: The mean age of the patients was 42.7 years. The mean uterine weight was 205 grams (range 69-1163 g), the mean operating time was 79 minutes, and the mean blood loss was 89 cc. The mean postoperative stay in the day surgery unit (DSU) was 354 minutes. Ten patients required admission from the DSU, and nine patients were admitted more than 24 hours after surgery. The total number of admission days was 24, which cost 21,900 US dollars. The total cost of all disposables was 127,373 US dollars and the cost associated with the stays in day surgery was 89,600 US dollars. The total cost for the 224 TLH procedures was 238,573 US dollars, and the average cost per TLH was 1065 US dollars. CONCLUSION: Outpatient TLH can be completed safely and with costs that are lower than those incurred by patients having short-stay vaginal hysterectomy in our institution. Outpatient TLH offers the opportunity to save health care costs and a procedure with excellent results.

Confirmation of Essure microinsert tubal coil placement with conventional and volume-contrast imaging three-dimensional ultrasound.

OBJECTIVE: To determine the accuracy of ultrasound in the assessment of proximal fallopian tube positioning of the Essure microinsert coil 3 months after postprocedure. DESIGN: Prospective cohort study (Canadian Task Force classification II-2). SETTING: Reproductive-age women in a tertiary care hospital. PATIENT(S): Reproductive-age women presenting with a request for permanent contraception. INTERVENTION(S): Hysteroscopic sterilization with the Essure microinsert coil and conventional or volume-contrast three-dimensional (3D) ultrasound imaging 3 months after the procedure. MAIN OUTCOME MEASURE(S): Coil position on ultrasound. RESULT(S): Forty-eight of the 50 patients had successful placement of the Essure coils, and three patients required a second attempt on one tube. Conventional or volume-contrast (3D) ultrasound showed proper positioning of the coils within the proximal fallopian tube in 42 women (84%); five women (10%) required hysterosalpingogram to show appropriate positioning. Two patients (4%) required laparoscopic tubal sterilization, and one patient (2%) was lost to follow-up. CONCLUSION(S): Transvaginal ultrasound is an acceptable method of confirming proper placement of the Essure microinsert coil within the proximal fallopian tube 3 months after the procedure.