Regional practice variation in hysterectomy and the implementation of less invasive surgical procedures: A register-based study in the Netherlands.

INTRODUCTION: Many women experience bleeding disorders that may have an anatomical or unexplained origin. Although hysterectomy is the most definitive and common treatment, it is highly invasive and resource-intensive. Less invasive therapies are therefore advised before hysterectomy for women with fibroids or bleeding disorders. This study has two aims related to treating bleeding disorders and uterine fibroids in the Netherlands: (1) to evaluate the regional variations in prevalence and surgical approaches; and (2) to assess the associations between regional rates of hysterectomies and less invasive surgical techniques to analyze whether hysterectomy can be replaced in routine practice. MATERIAL AND METHODS: We completed a register-based study of claims data for bleeding disorders and fibroids in women between 2016 and 2020 using data from Statistics Netherlands for case-mix adjustment. Crude and case-mix adjusted regional hysterectomy rates were examined overall and by surgical approach. Coefficients of variation were used to measure regional variation and regression analyses were used to evaluate the association between hysterectomy and less invasive procedure rates across regions. RESULTS: Overall, 14 186 and 8821 hysterectomies were performed for bleeding disorders and fibroids, respectively. Laparoscopic approaches predominated (bleeding disorders 65%, fibroids 49%), followed by vaginal (bleeding disorders 24%, fibroids 5%) and abdominal (bleeding disorders 11%, fibroids 46%) approaches. Substantial regional differences were noted in both hysterectomy rates and the surgical approaches. For bleeding disorders, regional hysterectomy rates were positively associated with endometrial ablation rates (ß = 0.11; P = 0.21) and therapeutic hysteroscopy rates (ß = 0.14; P = 0.31). For fibroids, regional hysterectomy rates were positively associated with therapeutic hysteroscopy rates (ß = 0.10; P = 0.34) and negatively associated with both embolization rates (ß = -0.08; P = 0.08) and myomectomy rates (ß = -0.03; P = 0.82). CONCLUSIONS: Regional variation exists in the rates of hysterectomy and minimally invasive techniques. The absence of a significant substitution effect provides no clear evidence that minimally invasive techniques have replaced hysterectomy in clinical practice. However, although the result was not significant, embolization could be an exception based on its stronger negative association.

A 52-mg levonorgestrel-releasing intrauterine system vs bipolar radiofrequency nonresectoscopic endometrial ablation in women with heavy menstrual bleeding: long-term follow-up of a multicenter randomized controlled trial.

BACKGROUND: The symptom of heavy menstrual bleeding has a substantial impact on professional, physical, and social functioning. In 2021, results from a randomized controlled trial comparing a 52-mg levonorgestrel-releasing intrauterine system and radiofrequency nonresectoscopic endometrial ablation as treatments for women with heavy menstrual bleeding were published. Both treatment strategies were equally effective in treating heavy menstrual bleeding during 2-year follow-up. However, long-term results are also relevant for both patients and healthcare providers. OBJECTIVE: This study aimed to assess long-term differences in reintervention risk and menstrual blood loss in women with the symptom of heavy menstrual bleeding treated according to a strategy starting with a 52-mg levonorgestrel-releasing intrauterine system or radiofrequency nonresectoscopic endometrial ablation. STUDY DESIGN: This study was a long-term follow-up study of a multicenter randomized controlled trial (MIRA trial), in which women were allocated to either a 52-mg levonorgestrel-releasing intrauterine device (n=132) or radiofrequency nonresectoscopic endometrial ablation (n=138). Women from the original trial were contacted to fill out 6 questionnaires. The primary outcome was the reintervention rate after allocated treatment. Secondary outcomes included surgical reintervention rate, menstrual bleeding measured by the Pictorial Blood Loss Assessment Chart, (disease-specific) quality of life, sexual function, and patient satisfaction. RESULTS: From the 270 women who were randomized in the original trial, 196 (52-mg levonorgestrel-releasing intrauterine system group: n=94; radiofrequency nonresectoscopic endometrial ablation group: n=102) participated in this long-term follow-up study. Mean follow-up duration was 7.4 years (range, 6-9 years). The cumulative reintervention rate (including both medical and surgical reinterventions) was 40.0% (34/85) in the 52-mg levonorgestrel-releasing intrauterine system group and 28.7% (27/94) in the radiofrequency nonresectoscopic endometrial ablation group (relative risk, 1.39; 95% confidence interval, 0.92-2.10). The cumulative rate of surgical reinterventions only was significantly higher among patients with a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system compared with radiofrequency nonresectoscopic endometrial ablation (35.3% [30/85] vs 19.1% [18/94]; relative risk, 1.84; 95% confidence interval, 1.11-3.10). However, the hysterectomy rate was similar (11.8% [10/94] in the 52-mg levonorgestrel-releasing intrauterine system group and 18.1% [17/102] in the radiofrequency nonresectoscopic endometrial ablation group; relative risk, 0.65; 95% confidence interval, 0.32-1.34). Most reinterventions occurred during the first 24 months of follow-up. A total of 171 Pictorial Blood Loss Assessment Chart scores showed a median bleeding score of 0.0. No clinically relevant differences were found regarding quality of life, sexual function, and patient satisfaction. CONCLUSION: The overall risk of reintervention after long-term follow-up was not different between women treated according to a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system and those treated using a strategy starting with radiofrequency nonresectoscopic endometrial ablation. However, women allocated to a treatment strategy starting with a 52-mg levonorgestrel-releasing intrauterine system had a higher risk of surgical reintervention, which was driven by an increase in subsequent endometrial ablation. Both treatment strategies were effective in lowering menstrual blood loss over the long term. The results of this long-term follow-up study can support physicians in optimizing the counseling of women with heavy menstrual bleeding, thus promoting informed decision-making regarding choice of treatment.

Central Sensitisation Syndrome: A Frequent Finding in Women with Pelvic Floor Symptoms Without Evident Urogenital Prolapse.

INTRODUCTION AND HYPOTHESIS: Women with central sensitisation syndrome (CSS) experience poorer subjective post-operative outcomes even after successful pelvic floor reconstruction. This study tests the hypothesis that women with pelvic floor symptoms (PFS) without relevant pelvic organ prolapse (POP), are more likely to have CSS. METHODS: A questionnaire was sent to women who participated in the POP-UP study in 2017. The POP-UP study evaluated POP in 247 women 16 years after laparoscopic or vaginal hysterectomy. POP-Q data and Pelvic Floor Distress Inventory (PFDI-20) results were used and supplemented with CSS-specific questionnaires. A Central Sensitisation Inventory (CSI) score above 40 implicates CSS. Women were divided into groups based on POP beyond the hymen in relation to the PFDI-20 score. Outcomes of women with PFS and without POP (called 'group 1') were compared with the rest of the cohort (groups 2-4; women without PFS and/or with POP). RESULTS: A total of 136 women were included in the analysis. A CSI score above 40 was present in 16 out of 42 women of group 1 (37%) versus 11 out of 93 women of groups 2-4 (12%), p < 0.0001. Passive coping was more prevalent in group 1 (p = 0.039), and more deviations in somatisation, depression, anxiety and distress were found in group 1 (p values of < 0.0001, 0.018, 0.003 and 0.002 respectively). CONCLUSIONS: This study suggests that CSS might be more prevalent in women with PFS without relevant POP. More awareness of CSS and valid individual counselling may overcome unnecessary surgery for POP and help in setting realistic expectations.

Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial.

BACKGROUND: Hysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last decade, surgical procedures are increasingly being performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating safety and effectiveness of hysteroscopic myomectomy under procedural sedation are lacking. This study aims to investigate whether hysteroscopic myomectomy under procedural sedation and analgesia with propofol is noninferior to hysteroscopic myomectomy under general anesthesia. METHODS AND FINDINGS: This was a multicenter, randomized controlled noninferiority trial conducted in 14 university and teaching hospitals in the Netherlands between 2016 and 2021. Inclusion criteria were age ≥18 years, maximum number of 3 type 0 or 1 fibroids, maximum fibroid diameter 3.5 cm, American Society of Anesthesiologists class 1 or 2, and having sufficient knowledge of the Dutch or English language. Women with clotting disorders or with severe anemia (Hb < 5.0 mmol/L) were excluded. Women were randomized using block randomization with variable block sizes of 2, 4, and 6, between hysteroscopic myomectomy under procedural sedation and analgesia (PSA) with propofol or under general anesthesia (GA). Primary outcome was the percentage of complete resections, assessed on transvaginal ultrasonography 6 weeks postoperatively by a sonographer blinded for the treatment arm and surgical outcome. Secondary outcomes were the surgeon's judgment of completeness of procedure, menstrual blood loss, uterine fibroid related and general quality of life, pain, recovery, hospitalization, complications, and surgical reinterventions. Follow-up period was 1 year. The risk difference between both treatment arms was estimated, and a Farrington-Manning test was used to determine the p-value for noninferiority (noninferiority margin 7.5% of incomplete resections). Data were analyzed according to the intention-to-treat principle, including a per-protocol analysis for the primary outcome. A total of 209 women participated in the study and underwent hysteroscopic myomectomy with PSA (n = 106) or GA (n = 103). Mean age was 45.1 [SD 6.4] years in the PSA group versus 45.0 [7.7] years in the GA group. For 98/106 women in the PSA group and 89/103 women in the GA group, data were available for analysis of the primary outcome. Hysteroscopic resection was complete in 86/98 women (87.8%) in the PSA group and 79/89 women (88.8%) in the GA group (risk difference -1.01%; 95% confidence interval (CI) -10.36 to 8.34; noninferiority, P = 0.09). No serious anesthesiologic complications occurred, and conversion from PSA to GA was not required. During the follow-up period, 15 serious adverse events occurred (overnight admissions). All were unrelated to the intervention studied. Main limitations were the choice of primary outcome and the fact that our study proved to be underpowered. CONCLUSIONS: Noninferiority of PSA for completeness of resection was not shown, though there were no significant differences in clinical outcomes and quality of life. In this study, hysteroscopic myomectomy for type 0 and 1 fibroids with PSA compared to GA was safe and led to shorter hospitalization. These results can be used for counseling patients by gynecologists and anesthesiologists. Based on these findings, we suggest that hysteroscopic myomectomies can be performed under PSA in an outpatient setting. TRIAL REGISTRATION: The study was registered prospectively in the Dutch Trial Register (NTR 5357; registration date: 11 August 2015; Date of initial participant enrollment: 18 February 2016).

The effectiveness and safety of laparoscopic uterosacral ligament suspension: A systematic review and meta-analysis.

BACKGROUND: Laparoscopic uterosacral ligament suspension (LUSLS) is a technique to correct apical pelvic organ prolapse (POP) by shortening the uterosacral ligaments with sutures. OBJECTIVE: A systematic review with meta-analysis of the effectiveness and safety of LUSLS as treatment for apical POP. SEARCH STRATEGY: PubMed and Cochrane search using 'pelvic organ prolapse', 'laparoscopy' and 'uterosacral', including synonyms. SELECTION CRITERIA: All articles in English presenting outcome of an original series of women with LUSLS as treatment of apical POP. Case reports were excluded. DATA COLLECTION AND ANALYSIS: Study enrollment was performed by two reviewers. Our primary outcome measures were objective and subjective effectiveness of the procedure. Secondary outcome measures regarded complications and recurrence. Bias was assessed with the Newcastle Ottawa Scale. MAIN RESULTS: Of 138 hits, 13 studies were included with 933 LUSLS patients. The average follow-up was 22 months. All were nonrandomised cohort studies. The pooled anatomic success rate is 90% for all LUSLS procedures (95% confidence interval [CI] 83.3-95.5). LUSLS with hysterectomy resulted in an anatomic success rate of 96.6% (95% CI 87.5-100) and LUSLS with uterus preservation 83.4% (95% CI 67.7-94.6). The pooled subjective cure rate was 90.5% (95% CI 81.9-96.5). The rate of major complications was 1%. CONCLUSIONS: Laparoscopic uterosacral ligament suspension (with or without uterus preservation) seems to be an effective and safe treatment for women with apical POP, but long-term prospective trials and randomised controlled trials are necessary to confirm these findings.

Procedural sedation and analgesia with propofol (PSA) for gynecologic surgery: A systematic review of the literature.

OBJECTIVE: To identify which gynecologic procedures are eligible to be performed under PSA with propofol and to describe safety and effectiveness of these procedures in this setting. METHODS: A systematic review of the literature was conducted in Pubmed (MEDLINE), Embase and The Cochrane Library from inception until September 21st 2022. Cohort studies and randomized controlled trials were included when they reported on clinical outcomes of gynecologic procedures under procedural sedation and analgesia in which propofol was used as an anesthetic. Studies were excluded when sedation without propofol was used, when they only mentioned the use of procedural sedation and analgesia but did not describe any clinical outcome parameters or when < 10 patients were included. The primary outcome parameter was completeness of procedure. Secondary outcome parameters were type of gynecologic procedure, intraoperative complication rate, patient satisfaction, postoperative pain, duration of hospital admission, patient's discomfort and ease of procedure as judged by the surgeon. The Cochrane risk of bias tool and the ROBINS-I tool were used for bias assessment. A narrative synthesis of the findings from the included studies was provided. Numbers and percentages were presented, as well as means with standard deviations and medians with interquartile range where applicable. RESULTS: Eight studies were included. A total of 914 patients underwent gynecologic surgical procedures with procedural sedation and analgesia with propofol. Gynecological procedures varied from hysteroscopic procedures, vaginal prolapse surgery and laparoscopic procedures. The percentage of complete procedures was 89.8%-100%. Complications occurred in 0-6.5% of patients. Other outcomes were measured in various ways, but overall patient satisfaction was high and postoperative pain was low. CONCLUSION: The use of PSA with propofol is promising for a wide range of gynecologic procedures, including hysteroscopic procedures, vaginal prolapse surgery and laparoscopic procedures. The use of PSA with propofol seems to be effective and safe and leads to high degree of patient satisfaction. More research is needed in order to determine for which types of procedures PSA can be used.

Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse: a randomised controlled trial and prospective cohort (SALTO-2 trial).

OBJECTIVE: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP-Q stage ≥2 vaginal vault prolapse (VVP). DESIGN: Multicentre randomised controlled trial (RCT) and prospective cohort study alongside. SETTING: Seven non-university teaching hospitals and two university hospitals in the Netherlands. POPULATION: Patients with symptomatic post-hysterectomy vaginal vault prolapse, requiring surgical treatment. METHODS: Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP-Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively. MAIN OUTCOME MEASURES: Primary outcome was disease-specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri-operative data, complications and sexual function. RESULTS: A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease-specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129). CONCLUSIONS: LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow-up period of 12 months.

Essure removal surgery: Are preoperative transvaginal ultrasound and pelvic X-ray necessary?

OBJECTIVE: The objective of this study was twofold. (1) To investigate the predictive characteristics of transvaginal ultrasonography for hysteroscopy necessity in Essure removal surgery. (2) To investigate the additional predictive value of a preoperative pelvic radiograph to transvaginal ultrasonography for hysteroscopy necessity. STUDY DESIGN: Retrospective cohort study, performed in an academic and a non-academic teaching hospital in the Netherlands. 71 women who underwent Essure removal surgery with a perioperative hysteroscopy and who had a preoperative pelvic X-ray and transvaginal ultrasound were included. Four experts first predicted hysteroscopy necessity based on transvaginal ultrasound description and secondly based on transvaginal ultrasound combined with the preoperative pelvic radiograph. Sensitivity, specificity, positive predictive value and negative predictive value of the predictive tests were calculated. RESULTS: Based on transvaginal ultrasound, the mean predictive characteristics for experts were: sensitivity 89.7% (range 66.7%-100%), specificity 37.4% (range 17.6%-67.7%), positive predictive value 18.8% (range 13.2%-29.5%) and negative predictive value 95.1% (range 86.1%-100%). After adding the pelvic radiograph to the transvaginal ultrasound descriptions, the results were: sensitivity 66.7% (range 53.3%-80%), specificity 72.6% (range 56%-97.3%), positive predictive value 23% (range 14.3%-26.9%) and negative predictive value 94.1 % (range 90.3%-98.4%). For three experts sensitivity decreased after adding the pelvic radiograph. For all experts specificity increased. CONCLUSION: It is difficult to preoperatively decide if the fourth marker of the Essure outer coil can be excised during hysteroscopy. The addition of pelvic radiography to transvaginal ultrasound is not beneficial. It is recommended to perform a hysteroscopy during Essure removal surgery.

The effects of Saline Infusion Sonography on the histological quality of endometrial sampling in women with postmenopausal bleeding.

BACKGROUND: The aim of this study is to analyze the histopathological features of endometrial samples obtained by aspiration when performed before or after the saline contrast sonohysterography in women with postmenopausal bleeding and a thickened endometrium. Hypothetically, the saline infusion could disrupt the tissue and therefore affect the quality of the sample. Furthermore, we want to determine which histological features have impact on the quality of the endometrial sample. METHODS: We performed a randomized controlled trial (ESPRESSO trial) in which we analyzed the aspiration samples in two groups. Women were allocated either to saline contrast sonohysterography and subsequent endometrial sampling (SCSH-Sampling group) or to the opposite order (Sampling-SCSH group). Dedicated gyneco-pathologists retrospectively assessed the specimens and recorded the type (blood, mucus, epithelium, intact glands, stroma and tissue context) and quantity (on a scale of 0-3) of material that was found in the specimens. RESULTS: This analysis consisted of 197 samples, with 101 women in the SCSH-Sampling group and 96 women in the Sampling-SCSH group. No significant differences were found in the histological features between the two groups. All significant histological features differed significantly in the sufficient samples compared to the insufficient samples: higher amounts of blood, more endometrial epithelium, presence of intact endometrial glands, better stroma and tissue context. Oppositely, a significantly higher amount of mucus was found in the insufficient samples. CONCLUSION: This study shows that the histological features of the endometrial sample were not affected by the saline contrast sonohysterography, when performed prior to the tissue sampling. Trial registration ESPRESSO TRIAL, NTR5690, registered 16 February 2016, https://trialsearch.who.int/Trial2.aspx?TrialID=NTR5690 .

Publication trends and usefulness of research in hysteroscopic myomectomy for heavy menstrual bleeding: A review of the published literature.

Despite the amount of research into hysteroscopic myomectomy, questions about the optimal treatment of heavy menstrual bleeding remain. This study reviewed publication trends on this topic from 2002 to 2019 and assessed the usefulness of studies. A total of 580 articles were published on PubMed in this time frame, in 15 different languages. There were meta-analyses (1.6%), systematic reviews (12%), and randomized controlled trials (4.2%). Twelve percent were published in high impact factor journals. After applying our selection criteria, the usefulness of 37 articles was assessed: one article scored high, 31 scored moderate, and five scored low. The costs of these studies were estimated at US$ 971 700.

Laparoscopic sacrohysteropexy versus vaginal sacrospinous hysteropexy as treatment for uterine descent: comparison of long-term outcomes.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) is a frequent occurring health issue, especially concerning elderly women. The objective of this study is to examine the long-term outcomes of laparoscopic sacrohysteropexy (LSH) and vaginal sacrospinous hysteropexy (SSHP) for treatment of uterine prolapse. METHODS: A retrospective study of patients who underwent a LSH or SSHP. Validated questionnaires and an outpatient examination visit were used to investigate the effects of both surgical treatments. The primary outcome was the composite outcome of success for the apical compartment, defined as no recurrence of uterine prolapse (POP-Q measurement C ≤ 0), no subjective recurrence of POP, and/or not requiring therapy for recurrent prolapse. Secondary outcomes were peri- and postoperative data, anatomical failure, prolapse beyond hymen, subjective outcomes, and disease-specific quality of life. RESULTS: We included 105 patients, 53 in the LSH group and 52 in the SSHP group. The overall response rate of the questionnaires was 83% (n = 87) after a mean follow-up time of 4.5 years (54.2 months; 95% CI 44.8-64.2 months) in the LSH group and 2.5 years (30.1 months; 95% CI 29.3-31.5 months) in the SSHP group. There were no clinically relevant differences between the study groups in composite outcome of success (p = 0.073), anatomical failure of the apical compartment (p = 0.711), vaginal bulge symptoms for which patients consulted professionals (p = 0.126), and patient satisfaction (p = 0.741). The operative time was longer in the LSH group (117 min; interquartile range (IQR) 110-123) compared to the SSHP group (67 minutes; IQR 60-73) (p < 0.001). The duration of hospital stay was also longer in the LSH group (4 days) than in the SSHP group (3 days) (p = 0.006). CONCLUSIONS: LSH and SSHP seem to be equally effective after long-term follow-up in treating uterine prolapse in terms of objective and subjective recurrence.

Laparoscopic sacrocolpopexy versus abdominal sacrocolpopexy for vaginal vault prolapse: long-term follow-up of a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to evaluate long-term outcomes of laparoscopic sacrocolpopexy (LSC) versus abdominal sacrocolpopexy (ASC) for vaginal vault prolapse (VVP). METHODS: Long-term follow-up of a multicenter randomized controlled trial (SALTO trial). A total of 74 women were randomly assigned to LSC (n=37) or ASC (n=37). Primary outcome was disease-specific quality of life, measured with validated questionnaires. Secondary outcomes included anatomical outcome, composite outcome of success, complications, and retreatment. RESULTS: We analyzed 22 patients in the LSC group and 19 patients in the ASC group for long-term follow-up, with a median follow-up of 109 months (9.1 years). Disease-specific quality of life did not differ after long-term follow-up with median scores of 0.0 (LSC: IQR 0-17; ASC: IQR 0-0) on the "genital prolapse" domain of the Urogenital Distress Inventory in both groups (p = 0.175). Anatomical outcomes were the same for both groups on all points of the POP-Q. The composite outcome of success for the apical compartment is 78.6% (n = 11) in the LSC group and 84.6% (n = 11) in the ASC group (p = 0.686). Mesh exposures occurred in 2 patients (12.5%) in the LSC group and 1 patient (7.7%) in the ASC group. There were 5 surgical reinterventions in both groups (LSC: 22.7%; ASC: 26.3%, p = 0.729). CONCLUSIONS: At long-term follow-up no substantial differences in quality of life, anatomical results, complications, or reinterventions between LSC and ASC were observed. Therefore, the laparoscopic approach is preferable, considering the short-term advantages. TRIAL REGISTRATION: Dutch Trial Register NTR6330, 18 January 2017, https://www.trialregister.nl/trial/5964.

Long-term results of transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the Sonata System: a retrospective follow-up study.

BACKGROUND: The Sonata System is a new minimally invasive, transcervical, uterine-sparing treatment option for fibroids with a mainly intramural location. The device combines intrauterine ultrasonography with radiofrequency ablation. Long-term follow-up data are still lacking. OBJECTIVE: This study aimed to evaluate long-term outcomes of the Sonata System in terms of surgical reintervention and to identify factors predicting surgical reintervention. Moreover, patient satisfaction, fibroid size reduction, and complication rate were evaluated. STUDY DESIGN: We performed a retrospective single-center cohort study of 53 women who underwent Sonata treatment between December 2011 and April 2019. Medical chart review was conducted to collect data on surgical reintervention and patient, fibroid, and surgery characteristics. The follow-up period lasted from date of initial surgery until April 2020. In addition, women filled out a questionnaire at a single time point (April 2020) containing questions about surgical reintervention and patient satisfaction.Kaplan-Meier analysis was used to determine cumulative reintervention rates and median time without reintervention. Univariate Cox regression analyses were performed to identify factors predicting surgical reintervention. RESULTS: Median follow-up period was 36 months (interquartile range, 22-58). Twenty-four women (45.3%) underwent a surgical reintervention, of which most were hysteroscopic myomectomies (45.8%). Surgical reintervention rates as determined by Kaplan-Meier analysis at 1-year and 2-year follow-up were 24.5% and 39.8%, respectively.Eventually, 7 women (13.2%) underwent a hysterectomy after the Sonata treatment. Univariate Cox regression analyses were performed, but did not show a significant association between surgical reintervention and age, preoperative fibroid size, type of ablated fibroid, number of ablated fibroids, and presence of other fibroids that could not be ablated during the Sonata procedure. Median fibroid diameter was 41 mm (interquartile range, 29-50) before and 29 mm (interquartile range, 20-40) after treatment (Z=-5.01; P<.001; 95% confidence interval, -13.0 to 7.0). Thirty-four women (69.4%) were satisfied with the treatment effect, and 42 women (85.7%) would recommend the Sonata treatment to other women. No device-related complications occurred. CONCLUSION: The Sonata System is a safe and minimally invasive treatment option for women suffering from (partly) intramural fibroids. The findings of this long-term follow-up study support counseling women for treatment with the Sonata System. More prospective studies with long-term follow-up are needed to investigate for which type and size of uterine fibroid the Sonata System is of most value.

Endometrial cancer after endometrial ablation: a systematic review.

OBJECTIVE: To investigate whether a previously performed endometrial ablation is associated with the development and diagnosis of endometrial cancer. METHODS: First, a systematic review was performed of the articles reporting the incidence of endometrial cancer in patients treated with endometrial ablation. Second, a systematic review was performed to identify all individual cases of endometrial cancer after ablation to evaluate presenting symptoms, diagnostic work-up, potential risk factors, and the type and stage of the endometrial cancer. A systematic search was performed, using Medline, EMBASE, and the Cochrane Library databases, from inception through February 24, 2022. RESULTS: Based on 11 included studies, the incidence of endometrial cancer in a population of 29 102 patients with a prior endometrial ablation ranged from 0.0% to 1.6%.A total of 38 cases of endometrial cancer after ablation were identified. In 71% of cases (17 of 24 cases), vaginal bleeding was the first presenting symptom. With transvaginal ultrasound it was possible to identify and measure the endometrial thickness in eight cases. Endometrium sampling was successful in 16 of 18 described cases (89%). In 18 of 20 cases (90%) pathologic examination showed early-stage endometrioid adenocarcinoma (International Federation of Gynecology and Obstetrics stage I). CONCLUSION: Previous endometrial ablation is not associated with the development of endometrial cancer. Diagnostic work-up is not impeded by previous endometrial ablation. In addition, endometrial cancers after endometrial ablation are not detected at an advanced stage.

Overnight removal of urinary indwelling catheter following vaginal prolapse surgery (OVERACT).

OBJECTIVE: Pelvic organ prolapse is a common condition in women. Adequate timing of urinary catheter removal after vaginal prolapse surgery is essential to reduce post-operative morbidity. We compared midnight removal of the indwelling urinary catheter to removal next morning. METHODS: We performed a retrospective cohort study among 266 women undergoing vaginal prolapse surgery, of whom 132 women had urinary catheter removal at midnight and 134 women morning after surgery. We compared the occurrence of urinary retention, time till first micturition, need for clean intermittent catherization and duration of hospital admission. Also, we assessed risk factors for the occurrence of retention. RESULTS: Retention occurred less after midnight removal of the urinary catheter, compared to removal next morning (6.1 % versus 23.9 %, p < 0.001). Furthermore, the time till catheter removal and discharge from hospital were shorter and the need for clean intermittent catheterization during hospital admission was lower after midnight compared to next morning removal of the urinary catheter. We identified anterior colporrhaphy as a risk factor for retention. CONCLUSION: Our results suggest that early removal of the indwelling urinary catheter after vaginal prolapse surgery seems save with respect to urinary retention and leads to earlier mobilization and shorter hospital admission.

Predictive factors of return to work after hysterectomy: a retrospective study.

PURPOSE: Although hysterectomy is one of the most frequently performed gynaecological surgeries, there is a dearth of evidence on perioperative care. The aim of the current study was to identify sociodemographic, surgical-related and work-related predictors of recovery following different approaches of hysterectomy. METHODS: Eligible patients for this retrospective cohort study were women who underwent vaginal, abdominal or laparoscopic hysterectomy for both benign and malignant gynaecological disease in 2014 in Máxima Medical Centre in the Netherlands. The main outcome measure was full return to work (RTW). Data were collected using a patient survey. Potential prognostic factors for time to RTW were examined in univariate Cox regression analyses. The strongest prognostic factors were combined in a multivariable model. RESULTS: In total 83 women were included. Median time to full return to work was 8 weeks (interquartile range [IQR] 6-12). The multivariable analysis showed that higher age (hazard ratio [HR] 1.053, 95% confidence interval [CI] 1.012-1.095) and same day removal of indwelling catheter (HR 0.122, 95% CI 0.028-0.539) were predictors of shorter duration until full RTW after hysterectomy. CONCLUSIONS: This study provided insight in the predictors of recovery after hysterectomy. By identifying patient specific factors, pre-operative counselling can be individualized, changes can be made in perioperative care and effective interventions can be designed to target those factors.

Transferrin Saturation/Hepcidin Ratio Discriminates TMPRSS6-Related Iron Refractory Iron Deficiency Anemia from Patients with Multi-Causal Iron Deficiency Anemia.

Pathogenic TMPRSS6 variants impairing matriptase-2 function result in inappropriately high hepcidin levels relative to body iron status, leading to iron refractory iron deficiency anemia (IRIDA). As diagnosing IRIDA can be challenging due to its genotypical and phenotypical heterogeneity, we assessed the transferrin saturation (TSAT)/hepcidin ratio to distinguish IRIDA from multi-causal iron deficiency anemia (IDA). We included 20 IRIDA patients from a registry for rare inherited iron disorders and then enrolled 39 controls with IDA due to other causes. Plasma hepcidin-25 levels were measured by standardized isotope dilution mass spectrometry. IDA controls had not received iron therapy in the last 3 months and C-reactive protein levels were <10.0 mg/L. IRIDA patients had significantly lower TSAT/hepcidin ratios compared to IDA controls, median 0.6%/nM (interquartile range, IQR, 0.4-1.1%/nM) and 16.7%/nM (IQR, 12.0-24.0%/nM), respectively. The area under the curve for the TSAT/hepcidin ratio was 1.000 with 100% sensitivity and specificity (95% confidence intervals 84-100% and 91-100%, respectively) at an optimal cut-off point of 5.6%/nM. The TSAT/hepcidin ratio shows excellent performance in discriminating IRIDA from TMPRSS6-unrelated IDA early in the diagnostic work-up of IDA provided that recent iron therapy and moderate-to-severe inflammation are absent. These observations warrant further exploration in a broader IDA population.

Recurrence and survival after laparoscopy versus laparotomy without lymphadenectomy in early-stage endometrial cancer: Long-term outcomes of a randomised trial.

BACKGROUND: Laparoscopic hysterectomy is accepted worldwide as the standard treatment option for early-stage endometrial cancer. However, there are limited data on long-term survival, particularly when no lymphadenectomy is performed. We compared the survival outcomes of total laparoscopic hysterectomy (TLH) and total abdominal hysterectomy (TAH), both without lymphadenectomy, for early-stage endometrial cancer up to 5 years postoperatively. METHODS: Follow-up of a multi-centre, randomised controlled trial comparing TLH and TAH, without routine lymphadenectomy, for women with stage I endometrial cancer. Enrolment was between 2007 and 2009 by 2:1 randomisation to TLH or TAH. Outcomes were disease-free survival (DFS), overall survival (OS), disease-specific survival (DSS), and primary site of recurrence. Multivariable Cox regression analyses were adjusted for age, stage, grade, and radiotherapy with adjusted hazard ratios (aHR) and 95% confidence intervals (95%CI) reported. To test for significance, non-inferiority margins were defined. RESULTS: In total, 279 women underwent a surgical procedure, of whom 263 (94%) had follow-up data. For the TLH (n = 175) and TAH (n = 88) groups, DFS (90.3% vs 84.1%; aHR[recurrence], 0.69; 95%CI, 0.31-1.52), OS (89.2% vs 82.8%; aHR[death], 0.60; 95%CI, 0.30-1.19), and DSS (95.0% vs 89.8%; aHR[death], 0.62; 95%CI, 0.23-1.70) were reported at 5 years. At a 10% significance level, and with a non-inferiority margin of 0.20, the null hypothesis of inferiority was rejected for all three outcomes. There were no port-site or wound metastases, and local recurrence rates were comparable. CONCLUSION: Disease recurrence and 5-year survival rates were comparable between the TLH and TAH groups and comparable to studies with lymphadenectomy, supporting the widespread use of TLH without lymphadenectomy as the primary treatment for early-stage, low-grade endometrial cancer.

Perioperative findings and complications in Essure® removal surgery.

OBJECTIVE: To analyze perioperative findings and complications in surgical removal of Essure® microinserts. STUDY DESIGN: A prospective cohort study of 274 patients who underwent surgical removal of Essure® microinserts. Outcomes of the surgical procedures and complications were entered into a digital case report form (CRF) by the surgeon and registered in an online database. Results were analyzed through IBM SPSS Statistics using descriptive statistical methods. RESULTS: During laparoscopic inspection in 15.4 % of fallopian tubes (n = 80) a chicken wing sign (the fallopian tube folding over the most distal part of the microinsert) was seen. Partial tubal perforation and total tubal perforation with migration of the microinsert out of the fallopian tube were seen in respectively 1.9 % (n = 10) and 0.2 % (n = 1) of cases. The microinserts were removed by laparoscopic tubotomy and extraction, followed by bilateral salpingectomy in 91.2 % of cases. In 7.3 % of cases (n = 20) a hysterectomy and bilateral salpingectomy was performed for additional indications than solely Essure® removal. Four microinserts were taken out entirely by means of hysteroscopy (1.5 %). We did not see major surgery related complications, however we found a risk of minor complications during or after surgery of respectively 1.6 % (n = 4) and 3.9 % (n = 10). CONCLUSIONS: During laparoscopic inspection, abnormalities were seen in 22.8 % (n = 119) of fallopian tubes, of which the chicken wing sign was the most common. Partial and total tubal perforation with migration of the microinsert were rare. The complication rate of Essure® removal surgery in our prospective study is low and complications are minor, without any major complication. However, while counseling patients with a request for surgical removal of Essure® microinserts, these results should be mentioned.

The combined use of endometrial ablation or resection and levonorgestrel-releasing intrauterine system in women with heavy menstrual bleeding: A systematic review.

INTRODUCTION: Despite endometrial ablation/resection being a very successful treatment for women with heavy menstrual bleeding, re-intervention with additional surgery is needed in 12%-25% of cases. Introducing a levonorgestrel-intrauterine system (LNG-IUS) immediately after ablation could preserve the integrity of the uterine cavity and suppress the regenerated or non-ablated endometrial tissue. Therefore, this combined treatment can perhaps lower the re-intervention rate. The aim of this systematic review was to assess the impact of the combined treatment. MATERIAL AND METHODS: The MEDLINE, EMBASE, and Cochrane library were systematically searched. No language restrictions were applied. All types of studies were included reporting on the results of endometrial ablation or resection combined with immediate insertion of LNG-IUS for treatment of heavy menstrual bleeding. The primary outcome was the number of hysterectomies after the ablation procedure. Secondary outcomes included re-intervention rates, removals of LNG-IUS, bleeding pattern, patient satisfaction, adverse effects, and complications. Our protocol was registered in PROSPERO, an international prospective register of systematic reviews under registration number CRD42020151384. RESULTS: Six studies with a retrospective design and one case series with a follow-up duration varying from 6 to 55 months were included. In total, 427 women were treated with the combined treatment. The studies described a lower hysterectomy and re-intervention rate after combined treatment compared with treatment with endometrial ablation/resection alone. Hysterectomy rate varied from 0% to 11% after combined treatment compared with 9.4% to 24% after endometrial ablation/resection alone. Bleeding patterns and patient satisfaction appeared to be in favor of the combined treatment group. No intra- or post-operative complications or complications in the removal of LNG-IUS were described. The most reported adverse effects after combined treatment were weight gain, mood changes, and headaches. An additional 11 studies with only an abstract available substantiated these findings. All the included studies had poor methodological quality. CONCLUSIONS: Based on the available literature, inserting an LNG-IUS immediately after endometrial ablation/resection seems to lower the hysterectomy and re-intervention rates compared with ablation/resection alone. However, as only limited observational studies of low methodological quality are available, high-quality research is necessary to confirm the findings of this systematic review.