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1.
Fertil Steril ; 2024 Aug 05.
Article in English | MEDLINE | ID: mdl-39098538

ABSTRACT

IMPORTANCE: Endometriosis is an inflammatory disease, with different forms of expression and a variety of complaints. An endometrioma, an ovarian cyst with endometrium-like lining, is one of the most common expressions of abdominal endometriosis. These endometriomas can, in addition to medical treatment, be treated surgically. After surgery, hormonal therapy is still frequently used for the treatment of endometriosis in general and prevention of recurrence of endometriomas specifically. However, not all women want or can receive postoperative hormonal treatment. It is important for this group to determine the risk of anatomical recurrence of ovarian endometrioma after surgery for an endometrioma. OBJECTIVE: To determine the recurrence rate for surgically treated endometrioma without postoperative hormonal treatment. DATA SOURCES: We performed a systematic literature review and meta-analyses, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. MEDLINE, Embase, and the Cochrane library were searched until May 2023. The literature search was limited to women with endometrioma who received surgical treatment without postoperative hormonal treatment. STUDY SELECTION AND SYNTHESIS: A distinction was made in study design including randomized controlled trials (RCTs) and cohort and retrospective studies. For assessment of risk of bias, the Cochrane Handbook for Systematic Reviews of Interventions and Risk of Bias in Non-randomized Studies - of Interventions assessment tool were used. MAIN OUTCOMES: The outcome measure included in this review was endometrioma recurrence. RESULTS: We screened 5,367 articles, of which 97 were systematically reviewed and 55 were included in this systematic review. Twelve of these were RCTs, 11 were prospective cohort studies, and 32 were retrospective studies. Nine RCTs had a low risk of bias. For non-RCTs, only 3 studies had a low risk of bias. Data of 23 studies were pooled in meta-analyses, performed for follow-up periods of 3, 6, 12, and 24 months. These studies showed recurrence rates of 4%, 14%, 17%, and 27%, respectively. CONCLUSION AND RELEVANCE: In the meta-analysis, at 24 months after surgery, the endometrioma recurrence rate showed a weighted mean of up to 27%. In this study, we aimed to determine the recurrence rate of endometrioma after surgical treatment in women without postoperative hormonal treatment use. The recurrence rates were up to 27%.

2.
BJOG ; 2024 Jul 17.
Article in English | MEDLINE | ID: mdl-39020078

ABSTRACT

OBJECTIVE: To evaluate whether physical function and quality of life was influenced by discharge on the same-day after a total laparoscopic hysterectomy. DESIGN: Multicentre non-inferiority randomised controlled trial. SETTING: Five teaching hospitals and two university hospitals in the Netherlands. POPULATION: Patients undergoing laparoscopic hysterectomy for benign or premalignant disease. METHODS: Following informed consent, participants were allocated 1:1 either to same-day discharge (SDD) or next-day discharge (NDD). MAIN OUTCOME MEASURES: The primary outcome was physical function at 7 days after surgery measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function short Form 10A. Secondary outcomes were physical function and quality of life at 1 and 3 days and 6 weeks after surgery measured with PROMIS short Form 10A and the EuroQol questionnaire (EQ-5D-5L). RESULTS: Two hundred and five patients were included of whom 105 were allocated to SDD and 100 to NDD. Physical function 7 days after surgery was 35.95 in the SDD group and 35.63 in the control group (mean difference 0.32; 95% CI [0.07-0.57]). As the upper limit of the 95% CI does not exceed the non-inferiority margin of 4 points, non-inferiority of SDD could be demonstrated. No difference in physical function nor quality of life on Days 1 and 3 and 6 weeks could be found. CONCLUSION: This research demonstrates same-day discharge after laparoscopic hysterectomy is non-inferior to next day discharge in physical function 7 days after surgery.

3.
Article in English | MEDLINE | ID: mdl-39075824

ABSTRACT

INTRODUCTION: Increasing evidence shows that conservative management of ovarian tumors classified as benign, based on ultrasound assessment, is safe. Therefore, conservative management has been adopted as the preferred strategy for certain ovarian tumors assessed as benign in the Dutch national guideline on enlarged ovaries in 2013. The aim of this study was to examine whether implementation of this guideline has led to changes in the number of women/100 000 women undergoing surgery for an ovarian tumor in the Netherlands. MATERIAL AND METHODS: Histopathology reports were requested for all examinations of ovarian and fallopian tube specimens (including cyst enucleations) registered in Palga, the Dutch nationwide pathology databank, from 2011 (before guideline adaptation) and 2019 (after guideline adaptation). Reports on prophylactically removed adnexa, removal for other primary tumors (e.g., endometrial carcinoma), and for patients under 18 years of age, were excluded from the analysis. Interobserver agreement for the inclusion and classification of reports was assessed using Cohen's Kappa analysis. RESULTS: A total of 34 932 reports were retrieved, 13 917 of which were included in the analysis. In 2011 and 2019, respectively, 96.3/100 000 versus 68.8/100 000 women aged ≥18 underwent surgery for benign ovarian tumors, and 19.6/100 000 versus 18.3/100 000 for borderline and malignant tumors combined. The number of women/100 000 who had surgery for a benign ovarian tumor per 100 000 women declined by 28.5% (p < 0.001) between 2011 and 2019. The largest difference between 2011 and 2019 was observed in the number of women per 100 000 women who underwent surgery for a serous cystadenoma (-40.7%; 20.8/100 000 vs. 12.3/100 000), followed by endometrioma (-33.2%; 14.7/100 000 vs. 9.8/100 000), simple epithelial cyst (-57.3%; 8.4/100 000 vs. 3.6/100 000), and corpus luteum cyst (-57.0%; 4.0/100 000 vs. 1.7/100 000). Cohen's Kappa for the interobserver agreement was 0.96. CONCLUSIONS: The number of women/100 000 undergoing surgery for a benign ovarian tumor has substantially decreased in the Netherlands when comparing data before and after implementation of the national guideline in 2013, while the number of women/100 000 undergoing surgery for a malignant or borderline tumor remained the same. These findings suggest successful implementation of the updated guideline, and a measurable effect on increased adoption of conservative management for benign-looking ovarian tumors.

4.
Acta Obstet Gynecol Scand ; 103(7): 1292-1301, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38629485

ABSTRACT

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.


Subject(s)
Hysterectomy , Leiomyoma , Practice Patterns, Physicians' , Registries , Uterine Neoplasms , Humans , Female , Netherlands , Hysterectomy/statistics & numerical data , Hysterectomy/methods , Leiomyoma/surgery , Adult , Middle Aged , Practice Patterns, Physicians'/statistics & numerical data , Uterine Neoplasms/surgery , Minimally Invasive Surgical Procedures/statistics & numerical data , Laparoscopy/statistics & numerical data , Uterine Hemorrhage/surgery , Uterine Hemorrhage/epidemiology
5.
Am J Obstet Gynecol ; 230(5): 542.e1-542.e10, 2024 05.
Article in English | MEDLINE | ID: mdl-38280433

ABSTRACT

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.


Subject(s)
Endometrial Ablation Techniques , Intrauterine Devices, Medicated , Levonorgestrel , Menorrhagia , Humans , Female , Levonorgestrel/administration & dosage , Levonorgestrel/therapeutic use , Menorrhagia/surgery , Endometrial Ablation Techniques/methods , Adult , Follow-Up Studies , Middle Aged , Patient Satisfaction , Quality of Life , Reoperation/statistics & numerical data , Treatment Outcome
6.
Int Urogynecol J ; 35(1): 227-236, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38165443

ABSTRACT

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.


Subject(s)
Pelvic Floor , Pelvic Organ Prolapse , Female , Humans , Pelvic Floor/surgery , Central Nervous System Sensitization , Pelvic Organ Prolapse/complications , Pelvic Organ Prolapse/surgery , Pelvic Organ Prolapse/diagnosis , Surveys and Questionnaires , Hysterectomy, Vaginal , Quality of Life
7.
BJOG ; 131(5): 684-689, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38073255

ABSTRACT

OBJECTIVE: To evaluate patient satisfaction on gynaecological examination with metal, plastic and biobased plastic vaginal specula, and to investigate whether patients are willing to compromise on comfort for a more sustainable healthcare system. DESIGN: Cross-sectional study: population-based survey. SETTING: Gynaecological outpatient clinics in five Dutch hospitals. POPULATION: Patients during general gynaecology consultation hours. METHODS: A survey containing two questions about patient demographics, four about comfort and five about sustainability and healthcare was distributed. MAIN OUTCOME MEASURES: Comfort score (scale 1-10). SECONDARY OUTCOMES: (1) temperature, size and ease of insertion, (2) willingness to compromise for a more sustainable healthcare system. RESULTS: In all, 196 patients completed the survey. Biobased plastic vaginal specula scored significantly higher on comfort than the metal ones (mean 8.03 ± 1.65 versus 7.26 ± 1.51 respectively; P < 0.001). The biobased plastic vaginal speculum is significantly the most comfortable on temperature, whereas the metal speculum is the least comfortable (P < 0.007). Most patients are willing to compromise on comfort or are open to the reuse of disposables to contribute to a more sustainable healthcare. The majority of patients (77%) urge healthcare organisations to combat climate change. CONCLUSIONS: There is a small but statistically significant difference in favour of a biobased plastic speculum regarding comfort score, although it might be questioned whether this is clinically relevant. Furthermore, patients are willing to compromise on comfort for a more sustainable healthcare, which should be a contributing factor in speculum selection.


Subject(s)
Climate Change , Patient Preference , Female , Humans , Cross-Sectional Studies , Surgical Instruments , Surveys and Questionnaires
8.
PLoS Med ; 20(12): e1004323, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38153958

ABSTRACT

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).


Subject(s)
Analgesia , Leiomyoma , Propofol , Uterine Myomectomy , Uterine Neoplasms , Humans , Female , Middle Aged , Adolescent , Uterine Myomectomy/adverse effects , Uterine Myomectomy/methods , Uterine Neoplasms/surgery , Uterine Neoplasms/complications , Propofol/adverse effects , Quality of Life , Leiomyoma/surgery , Anesthesia, General/adverse effects , Pain/etiology
9.
Obstet Gynecol ; 142(5): 1262-1263, 2023 Nov 01.
Article in English | MEDLINE | ID: mdl-37856858
10.
Haemophilia ; 29(6): 1573-1579, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37758646

ABSTRACT

BACKGROUND: The International Society on Thrombosis and Haemostasis bleeding assessment tool (ISTH-BAT), is used during the diagnostic workup of bleeding disorders. Data on ISTH-BAT scores in women with heavy menstrual bleeding (HMB) undergoing endometrial ablation (EA) could be essential in optimizing HMB counselling. OBJECTIVE: To investigate the postsurgical incidence of amenorrhea, dysmenorrhea, quality of life, re-intervention after EA, and ISTH-BAT score. METHODS: This study included women who have undergone EA because of HMB. During a follow-up of 2 to 5 years, ISTH-BAT, pictorial blood assessment chart (PBAC), and Short Form-36 survey (SF-36) were administered. At 10 years of follow-up surgical re-interventions were evaluated. RESULTS: Seventy-one women were included of whom 77% (n = 55) had an ISTH-BAT score < 6, versus 23% (n = 16) ISTH-BAT score ≥6 (mean age 46.3 versus 42.3, p = 0.004). In the ISTH-BAT ≥6 group versus < 6 group, amenorrhea occurred in 63% (10/16) versus 82% (45/55) (p = 0.111), dysmenorrhea in 38% (6/16) versus 18% (10/55) (p = 0.111), and surgical re-intervention in 19% (3/16) versus 25% (14/55) (p = 0.582). SF-36 item (Bodily) pain was lower in the ISTH-BAT ≥6 group versus < 6 (median score 58.7 vs. 80.0, p = 0.104). CONCLUSIONS: An ISTH-BAT score ≥6 may be related to a lower amenorrhea incidence and higher dysmenorrhea rate after EA.


Subject(s)
Endometrial Ablation Techniques , Menorrhagia , Thrombosis , Female , Humans , Middle Aged , Menorrhagia/surgery , Dysmenorrhea/surgery , Amenorrhea , Quality of Life , Hemorrhage , Hemostasis
11.
JMIR Form Res ; 7: e32592, 2023 Aug 03.
Article in English | MEDLINE | ID: mdl-37535412

ABSTRACT

BACKGROUND: Social support groups are an important resource for people to cope with problems. Previous studies have reported the different types of support in these groups, but little is known about the type of reactions that sharing of personal experiences induce among members. It is important to know how and to what extent members of support groups influence each other regarding the consumption of medical care. We researched this in a web-based Facebook group of women sterilized with Essure. Essure was a device intended for permanent contraception. From 2015 onward, women treated with Essure for tubal occlusion raised safety concerns and numerous complaints. OBJECTIVE: This study aimed to evaluate the use of social support in a Facebook community named "Essure problemen Nederland" (EPN; in English, "Essure problems in the Netherlands"). METHODS: All posts in the closed Facebook group EPN between March 8 and May 8, 2018, were included. In total, 3491 Facebook posts were analyzed using a modified version of the Social Support Behavior Codes framework created by Cutrona and Suhr in 1992. Posts were abstracted and aggregated into a database. Two investigators evaluated the posts, developed a modified version of the Social Support Behavior Codes framework, and applied the codes to the collected data. RESULTS: We found that 92% of messages contained a form of social support. In 68.8% of posts, social support was provided, and in 31.2% of posts, social support was received. Informational and emotional support was the most frequently used form of provided social support (40.6% and 55.5%, respectively). The same distribution was seen with received social support: informational support in 81.5% and emotional support in 17.4% of cases. Our analysis showed a strong correlation between providing or receiving social support and the main form of social support (P<.001). In a total of only 74 (2.2%) cases, women advised each other to seek medical care. CONCLUSIONS: The main purpose of women in the EPN Facebook group was to provide and receive informational or emotional support or both.

12.
Obstet Gynecol ; 142(1): 51-60, 2023 Jul 01.
Article in English | MEDLINE | ID: mdl-37290114

ABSTRACT

OBJECTIVE: To assess the risk of hysterectomy after nonresectoscopic endometrial ablation in patients with heavy menstrual bleeding. DATA SOURCES: The EMBASE, MEDLINE, ClinicalTrials.gov and Cochrane databases were searched for eligible articles from inception until June 13, 2022. We used combinations of search terms for endometrial ablation and hysterectomy. METHODS OF STUDY SELECTION: Articles included in the review described the incidence of hysterectomy at a specific point in time after ablation with a minimum follow-up duration of 12 months. TABULATION, INTEGRATION, AND RESULTS: The literature search yielded a total of 3,022 hits. A total of 53 studies met our inclusion and exclusion criteria, including six retrospective studies, 24 randomized controlled trials, and 23 prospective studies. A total of 48,071 patients underwent endometrial ablation between 1992 and 2017. Follow-up duration varied between 12 and 120 months. Analyses per follow-up moment showed 4.3% hysterectomy rate at 12 months of follow-up (n=29 studies), 11.1% at 18 months (n=1 study), 8.0% at 24 months (n=11 studies), 10.2% at 36 months (n=12 studies), 7.6% at 48 months (n=2 studies), and 12.4% at 60 months (n=6 studies). Two studies reported a mean hysterectomy rate at 10 years after ablation of 21.3%. Minimal clinically relevant differences in hysterectomy rates were observed among the different study designs. Furthermore, we found no significant differences in hysterectomy rate among the different nonresectoscopic endometrial ablation devices. CONCLUSION: The risk of hysterectomy after endometrial ablation seems to increase from 4.3% after 1 year to 12.4% after 5 years. Clinicians can use the results of this review to counsel patients about the 12% risk of hysterectomy 5 years after endometrial ablation. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42020156281.


Subject(s)
Endometrial Ablation Techniques , Menorrhagia , Female , Humans , Endometrial Ablation Techniques/methods , Prospective Studies , Retrospective Studies , Hysterectomy , Menorrhagia/surgery
13.
Eur J Obstet Gynecol Reprod Biol ; 287: 137-146, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37327552

ABSTRACT

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.


Subject(s)
Analgesia , Propofol , Uterine Prolapse , Humans , Female , Propofol/adverse effects , Analgesia/methods , Pain, Postoperative/drug therapy , Gynecologic Surgical Procedures/adverse effects
14.
BJOG ; 130(13): 1568-1578, 2023 12.
Article in English | MEDLINE | ID: mdl-37271736

ABSTRACT

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.


Subject(s)
Laparoscopy , Pelvic Organ Prolapse , Female , Humans , Treatment Outcome , Prospective Studies , Uterus/surgery , Pelvic Organ Prolapse/surgery , Ligaments/surgery , Laparoscopy/adverse effects , Laparoscopy/methods , Gynecologic Surgical Procedures/adverse effects , Gynecologic Surgical Procedures/methods
15.
Eur J Obstet Gynecol Reprod Biol ; 286: 102-106, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37235926

ABSTRACT

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.


Subject(s)
Sterilization, Tubal , Pregnancy , Female , Humans , Retrospective Studies , X-Rays , Hysteroscopy/methods , Radiography , Ultrasonography
16.
BJOG ; 130(12): 1542-1551, 2023 11.
Article in English | MEDLINE | ID: mdl-37132094

ABSTRACT

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.


Subject(s)
Laparoscopy , Pelvic Organ Prolapse , Female , Humans , Gynecologic Surgical Procedures/adverse effects , Vagina/surgery , Pelvic Organ Prolapse/surgery , Pelvic Organ Prolapse/etiology , Hysterectomy/adverse effects , Treatment Outcome , Surgical Mesh/adverse effects , Laparoscopy/adverse effects
17.
BMC Womens Health ; 23(1): 115, 2023 03 21.
Article in English | MEDLINE | ID: mdl-36944980

ABSTRACT

BACKGROUND: The aim of this study was to describe the natural course of pelvic floor symptoms and pelvic floor anatomy for women long-term after hysterectomy. METHODS: Women who underwent hysterectomy between 1996-2004 carried out the PFDI-20 questionnaire and POP-Q examination. We collected data on the presence and type of pelvic floor symptoms and its relation to the degree of pelvic organ prolapse (POP) per compartment (≥ stage 2). RESULTS: We obtained data from 247 women on average sixteen years after hysterectomy, with no prolapse (n = 94), anterior prolapse (n = 76), posterior prolapse (n = 38), both anterior- and posterior prolapse (n = 20), and a prolapse involving the vaginal vault (n = 19). Of all 153 women with ≥ stage 2 prolapse, 80 (52%) experienced moderate and/or severe symptoms of the PFDI-20. Most frequently reported symptoms by women with POP were uncontrollable flatus, urinary frequency and urge incontinence. Bulging was associated with a prolapse beyond the hymen. 39% Of women without prolapse experienced bothersome pelvic floor symptoms as well. Most often these were stress incontinence, straining to pass stool and incomplete bowel emptying. Women with a history of hysterectomy for prolapse have more pelvic floor symptoms than women who underwent hysterectomy for other indications, regardless of the current presence of POP (57% versus 40%, p = 0.009). CONCLUSION: In a group of post-hysterectomy women who did not actively seek help, 47% experienced problematic pelvic floor symptoms, independent of the presence or absence of an anatomic POP. Creating more knowledge and awareness of the impact of hysterectomy on the pelvic floor can help women in the future. TRIAL REGISTRATION: The study was registered in the Dutch Trial Registry; Trial NL5967 (NTR6333, 2017-02-01) and approved by the Medical Research Ethics Committee of the Máxima Medical Center (NL60096.015.16, 2017-02-24).


Subject(s)
Pelvic Organ Prolapse , Urinary Incontinence, Stress , Female , Humans , Hysterectomy/adverse effects , Pelvic Floor , Pelvic Organ Prolapse/surgery , Surveys and Questionnaires , Urinary Incontinence, Stress/etiology , Vagina
18.
BMC Womens Health ; 23(1): 46, 2023 02 04.
Article in English | MEDLINE | ID: mdl-36739405

ABSTRACT

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 .


Subject(s)
Hysteroscopy , Postmenopause , Female , Humans , Pregnancy , Retrospective Studies , Sodium Chloride , Endometrium/diagnostic imaging , Endometrium/pathology , Uterine Hemorrhage/diagnostic imaging , Ultrasonography
19.
Eur J Obstet Gynecol Reprod Biol ; 283: 6-12, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36746074

ABSTRACT

INTRODUCTION: Heavy menstrual bleeding (HMB) affects a quarter of all women, with half having no structural cause. Dutch guidelines recommend a stepped care approach to the management of such idiopathic HMB, starting with medication or a levonorgestrel-releasing intrauterine device (LNG-IUD), before progressing to endometrial ablation, and ultimately, hysterectomy. However, practice variation between hospitals could lead to suboptimal health outcomes and increased healthcare costs for some women. OBJECTIVES: To evaluate adherence to stepped care for women with idiopathic HMB and to identify practice variation among Dutch hospitals. STUDY DESIGN: This population-based cross-sectional study used Dutch insurance claims data from primary and secondary care for all women with idiopathic HMB referred to a gynecologist between January 2019 and December 2020. We calculated the average number of treatments in the 3 years before each treatment step at each hospital, making adjustments for age, socioeconomic status, and ethnicity. Variation in medical practice was measured by the coefficient of variation (CV). RESULTS: We studied 20,715 women treated with LNG-IUDs (56%), endometrial ablation (36%), laparoscopic hysterectomy (13%), or vaginal hysterectomy (4%) in 93 hospitals. Before endometrial ablation, on average 47% used medication (hospital range 27%-71%; CV 0.17) and 16% used an LNG-IUD (hospital range 8%-29%, CV 0.32). Before hysterectomy, 52% (hospital range 28%-65%, CV 0.16) used medication, 21% (hospital range 6%-38%, CV 0.35) used an LNG-IUD, and 23% underwent endometrial ablation (hospital range 0%-59%, CV 0.55). On average, women underwent 0.63 (hospital range 0.36-1.00, adjusted rate 0.40-0.98, CV 0.17) and 0.96 (hospital range 0.56-1.45, adjusted rate 0.56-1.44, CV 0.18) treatments before endometrial ablation and hysterectomy, respectively. CONCLUSIONS: Considerable practice variation exists among Dutch hospitals in the stepped care approach to idiopathic HMB. Improving adherence to this approach could improve quality of care and reduce costs.


Subject(s)
Intrauterine Devices, Medicated , Menorrhagia , Female , Humans , Menorrhagia/drug therapy , Cross-Sectional Studies , Intrauterine Devices, Medicated/adverse effects , Levonorgestrel/therapeutic use , Hysterectomy/adverse effects
20.
Int Urogynecol J ; 34(1): 211-223, 2023 01.
Article in English | MEDLINE | ID: mdl-35482083

ABSTRACT

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.


Subject(s)
Laparoscopy , Pelvic Organ Prolapse , Uterine Prolapse , Female , Humans , Aged , Uterine Prolapse/surgery , Retrospective Studies , Quality of Life , Treatment Outcome , Gynecologic Surgical Procedures , Pelvic Organ Prolapse/surgery
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