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BACKGROUND: Traditionally, curettage has been the most widely performed surgical intervention for removing retained products of conception. However, hysteroscopic removal is increasingly performed as an alternative because of the potentially lower risk of intrauterine adhesions and higher rates of complete removal. Until recently, studies comparing curettage with hysteroscopic removal regarding reproductive and obstetrical outcomes were limited, and data conflicting. OBJECTIVE: This study aimed to assess reproductive and obstetrical outcomes in women wishing to conceive after removal of retained products of conception by hysteroscopy or ultrasound-guided electric vacuum aspiration. STUDY DESIGN: This was a prospective long-term follow-up study, conducted in 3 teaching hospitals and 1 university hospital. Patients were included from April 2015 until June 2022 for follow-up, either in a randomized controlled, nonblinded trial on the risk of intrauterine adhesions after removal of retained products of conception, or in a cohort alongside the randomized trial. Women with an ultrasonographic image suggestive of retained products of conception ranging from 1 to 4 cm were eligible. Surgical procedures in the randomized controlled trial were hysteroscopic morcellation or ultrasound-guided electric vacuum aspiration. In the cohort study, hysteroscopic treatment included hysteroscopic morcellation or cold loop resection compared with ultrasound-guided electric vacuum aspiration. RESULTS: A total of 261 out of 305 patients (85.6%) were available for follow-up after removal of retained products of conception, resulting in a cohort of 171 women after hysteroscopic removal and 90 women after removal by ultrasound-guided vacuum aspiration. Respectively, 92 of 171 women (53.8%) in the hysteroscopic removal group and 56 of 90 (62.2%) in the electric vacuum aspiration group wished to conceive (P=.192). Subsequent pregnancy rates were 88 of 91 (96.7%) after hysteroscopic removal and 52 of 56 (92.9%) after electric vacuum aspiration (P=.428). The live birth rates were 61 of 80 (76.3%) and 37 of 48 (77.1%) after hysteroscopic removal and electric vacuum aspiration, respectively (P=.914), with 8 of 88 pregnancies (9.1%) in the hysteroscopic removal group and 4 of 52 (7.7%) in the electric vacuum aspiration group still ongoing at follow-up (P=1.00). The median time to conception was 8.2 weeks (interquartile range, 5.0-17.2) in the hysteroscopic removal group and 6.9 weeks (interquartile range, 5.0-12.1) in the electric vacuum aspiration group (P=.262). The overall placental complication rate was 13 of 80 (16.3%) in the hysteroscopic removal group and 11 of 48 (22.9%) in the electric vacuum aspiration group (P=.350). CONCLUSION: Hysteroscopic removal and ultrasound-guided electric vacuum aspiration of retained products of conception seem to have no significantly different effects on subsequent live birth rate, pregnancy rate, time to conception, or pregnancy complications. Reproductive and obstetrical outcomes after removal of retained products of conception are reassuring, albeit with a high risk of placental complications.
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Histeroscopía , Retención de la Placenta , Ultrasonografía Intervencional , Legrado por Aspiración , Humanos , Femenino , Histeroscopía/métodos , Adulto , Embarazo , Estudios de Seguimiento , Estudios Prospectivos , Legrado por Aspiración/métodos , Retención de la Placenta/cirugía , Retención de la Placenta/diagnóstico por imagen , Índice de Embarazo , Adherencias Tisulares/cirugíaRESUMEN
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.
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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).
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Analgesia , Leiomioma , Propofol , Miomectomía Uterina , Neoplasias Uterinas , Humanos , Femenino , Persona de Mediana Edad , Adolescente , Miomectomía Uterina/efectos adversos , Miomectomía Uterina/métodos , Neoplasias Uterinas/cirugía , Neoplasias Uterinas/complicaciones , Propofol/efectos adversos , Calidad de Vida , Leiomioma/cirugía , Anestesia General/efectos adversos , Dolor/etiologíaRESUMEN
We aim to compare endometrial cancer survival in women with or without histological proven endometriosis or adenomyosis. We identified all women with endometrial cancer between 1990 and 2015 from the Netherlands Cancer Registry (NCR). Data were linked to the Dutch pathology database (PALGA) to select all women with histological proven endometriosis/adenomyosis. Overall survival was compared between women with endometrial cancer with or without endometriosis/adenomyosis. We used multivariable Cox proportional hazard analysis to estimate hazard ratios (HRs). We included 1701 women with endometrial cancer and endometriosis/adenomyosis, of whom 1236 (72.7%) women had adenomyosis, 320 (18.8%) had endometriosis and 145 (8.5%) had both. We compared these women to 39 139 women with endometrial cancer without endometriosis/adenomyosis. Women in the combined endometriosis/adenomyosis cohort were younger at endometrial cancer diagnosis, had earlier disease stage, more often had endometrioid endometrial cancer and low grade tumors. The 5-year survival rate in the combined endometriosis/adenomyosis cohort was 84.8% (95% CI 84.6-88.1) and 71.6% (95% CI 71.1-72.0) in the nonendometriosis/adenomyosis cohort. Univariable analysis resulted in a crude HR of 0.63 (95% CI 0.59-0.69). Significant confounding factors were age, stage, cancer subtype, histological grading, surgery and chemotherapy rate. Correction for these confounders resulted in a HR of 0.98 (95% CI 0.90-1.06). Including endometriosis/adenomyosis status as a categorical factor resulted in similar HRs. In conclusion, women with endometrial cancer and histologically proven endometriosis/adenomyosis have a better overall survival when compared to women with endometrial cancer without endometriosis/adenomyosis. This better survival was correlated to stage, grade, age and histological subtype, but not to the presence of endometriosis/adenomyosis.
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Adenomiosis , Neoplasias Endometriales , Endometriosis , Adenomiosis/patología , Estudios de Cohortes , Neoplasias Endometriales/patología , Endometriosis/complicaciones , Femenino , Humanos , Masculino , Pronóstico , Estudios RetrospectivosRESUMEN
OBJECTIVE: Assessing the association between endometriosis and/or adenomyosis and ovarian cancer. METHODS: We identified all women with histological proven endometriosis (51,544 women) and/or adenomyosis (85,015 women) from the Dutch pathology database (1990-2015) and matched with women with a benign dermal nevus (132,654 women). Histology results for ovarian cancer were retrieved. We estimated crude and age-adjusted incidence rate ratios (IRR) for ovarian cancer. RESULTS: We found 1017 (2.0%), 1284 (1.5%) and 471 (0.4%) ovarian cancer cases in the endometriosis, adenomyosis and nevus cohort, respectively. The age-adjusted IRRs were 19.75 (95% CI 16.70-23.35) in the endometriosis cohort and 5.93 (95% CI 4.91-7.16) in the adenomyosis cohort. The highest IRRs were found for endometrioid and clear cell ovarian cancer subtypes. Excluding the first year of follow-up did not result in a significant IRR for ovarian cancer overall but resulted in a statistically significant age-adjusted IRR of 3.92 (95% CI 2.19-7.01) for clear cell ovarian cancer and 2.39 (95% CI 1.28-4.45) for endometrioid ovarian cancer in the endometriosis cohort. Additionally, we found a statistically significant age-adjusted IRR of 2.51 (95% CI 1.29-4.90) for endometrioid ovarian cancer in the adenomyosis cohort. CONCLUSION: We found an increased ovarian cancer incidence in both histological proven endometriosis and adenomyosis. This increased incidence was largest for endometriosis. Excluding the first year of follow-up resulted in an increased incidence for endometrioid ovarian cancer in both cohorts and clear cell ovarian cancer in the endometriosis cohort. This study shows that gynecologist should also be aware of an increased ovarian cancer incidence in women with adenomyosis.
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Adenomiosis/epidemiología , Carcinoma Epitelial de Ovario/epidemiología , Endometriosis/epidemiología , Neoplasias Ováricas/epidemiología , Adulto , Estudios de Cohortes , Femenino , Humanos , Incidencia , Persona de Mediana Edad , Países Bajos/epidemiología , Sistema de Registros , Medición de RiesgoRESUMEN
BACKGROUND: Contradicting results regarding ovarian cancer prognosis in women with endometriosis have been reported in the literature. Owing to the small sample size of previous studies, larger studies are required to elucidate the role of endometriosis in ovarian cancer prognosis. OBJECTIVE: This study aimed to evaluate the survival rate in women with ovarian cancer with or without histologically proven endometriosis in a Dutch population-based cohort. STUDY DESIGN: All women with ovarian cancer diagnosed between 1990 and 2015 were identified from the Netherlands Cancer Registry. We linked these women with the Dutch nationwide registry of histopathology and cytopathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief) to identify all women with histologically proven endometriosis. We compared the prognosis of patients with ovarian cancer with and without histologically proven endometriosis. Primary outcome was the overall survival with subgroup analyses stratified by histologic ovarian cancer subtype and stage. Multivariable Cox proportional hazard analysis was used to estimate hazard ratios with 95% confidence intervals. RESULTS: We included 32,419 patients with ovarian cancer, of whom 1979 (6.1%) had histologically proven endometriosis. The median age of histologic endometriosis diagnosis was 53 years (interquartile range, 46-62). Of all women with ovarian cancer and endometriosis, 81.2% received a diagnosis of synchronous endometriosis and ovarian cancer. The endometriosis cohort was younger at ovarian cancer diagnosis, had more favorable tumor characteristics, and more often had surgical treatment for ovarian cancer than the women without endometriosis. These variables were included in the multivariable model as confounders. Women with histologically proven endometriosis had a significantly better prognosis in both crude and adjusted analyses (hazard ratio, 0.46; 95% confidence interval, 0.43-0.49; P<.0005, and adjusted hazard ratio, 0.89; 95% confidence interval, 0.83-0.95; P<.05, respectively). CONCLUSION: Women with ovarian cancer and histologically proven endometriosis had longer overall survival than women with ovarian cancer without endometriosis, even after adjustment for confounders. Future studies on ovarian cancer treatment and prognosis should consider stratifying by endometriosis status to elucidate its role. Furthermore, women diagnosed as having ovarian cancer and concurrent endometriosis should be explained the role of endometriosis in ovarian cancer survival.
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Endometriosis/complicaciones , Endometriosis/mortalidad , Enfermedades del Ovario/complicaciones , Enfermedades del Ovario/mortalidad , Neoplasias Ováricas/complicaciones , Neoplasias Ováricas/mortalidad , Anciano , Estudios de Cohortes , Femenino , Humanos , Persona de Mediana Edad , Países Bajos , Pronóstico , Estudios Retrospectivos , Tasa de SupervivenciaRESUMEN
INTRODUCTION: Magnetic resonance imaging (MRI) diagnosis of adenomyosis is considered the most accurate non-invasive technique, but remains subjective, with no consensus on which diagnostic parameters are most accurate. We aimed to systematically review the literature on how adenomyosis can be objectively quantified on MRI in a scoping manner, to review the diagnostic performance of these characteristics compared with histopathological diagnosis, and to summarize correlations between measures of adenomyosis on MRI and clinical outcomes. MATERIAL AND METHODS: We searched databases Pubmed, Embase, and Cochrane for relevant literature up to April 2020 according to PRISMA guidelines. We included studies that objectively assessed adenomyosis on MRI, and separately assessed studies investigating the diagnostic performance of MRI vs histopathology for inclusion in a meta-analysis. The QUADAS-2 tool was used for risk of bias, with many studies showing an unclear or high risk of bias. RESULTS: Eighty studies were included, of which 14 assessed the diagnostic performance of individual MRI parameters, with four included in the meta-analysis of diagnostic accuracy. Common MRI parameters were: junctional zone (JZ) characteristics, such as maximum JZ thickness-pooled sensitivity 71.6% (95% CI 46.0%-88.2%), specificity 85.5% (52.3%-97.0%); JZ differential-pooled sensitivity 58.9% (95% CI 44.3%-72.1%), specificity 83.2% (95% CI 71.3%-90.8%); and JZ to myometrial ratio-pooled sensitivity 63.3% (95% CI 51.9%-73.4%), specificity 79.4% (95% CI 42.0%-95.4%); adenomyosis lesion size, uterine morphology (pooled sensitivity 42.9% (95% CI 15.9%-74.9%), specificity 87.7%, (95% CI 37.9-98.8) and changes in signal intensity-eg, presence of myometrium cysts; pooled 59.6% (95% CI 41.6%-75.4%) and specificity of 96.1% (95% CI 80.7%-99.3%). Other MRI parameters have been used for adenomyosis diagnosis, but their diagnostic performance is unknown. Few studies attempted to correlate adenomyosis MRI phenotype to clinical outcomes. CONCLUSIONS: A wide range of objective parameters for adenomyosis exist on MRI; however, in many cases their individual diagnostic performance remains uncertain. JZ characteristics remain the most widely used and investigated with acceptable diagnostic accuracy. Specific research is needed into how these objective measures of adenomyosis can be correlated to clinical outcomes.
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Adenomiosis/diagnóstico por imagen , Femenino , Humanos , Imagen por Resonancia Magnética , Valor Predictivo de las PruebasRESUMEN
BACKGROUND: Several studies have suggested that endometriosis is associated with an increased risk of ovarian cancer, especially for the clear-cell and endometrioid subtypes. However, previous studies lack sufficient power or diagnostic certainty. OBJECTIVE: The objective of the study was to assess the association between histologically proven endometriosis and ovarian cancer in a large population-based cohort study. STUDY DESIGN: We identified 131,450 women with a histological diagnosis of endometriosis between 1990 and 2015 from the Dutch nationwide registry of histopathology and cytopathology (PALGA). For the control cohort 132,654 women with a benign dermal nevus were matched on age and inclusion year with the endometriosis cases. Histological diagnoses of ovarian, fallopian tubes, and peritoneal cancers between January 1990 and July 2017 were retrieved. Incidence rate ratios were estimated for ovarian cancer and its subtypes for the whole follow-up period as well as for women with more than 1 person-year at risk. RESULTS: We found a crude incidence rate ratio of 4.79 (95% confidence interval, 4.33-5.31) and an age-adjusted incidence rate ratio of 7.18 (95% confidence interval, 6.17-8.36) for ovarian cancer overall. Endometrioid and clear-cell ovarian cancer had the highest age-adjusted incidence rate ratio of 29.06 (95% confidence interval, 20.66-40.87) and 21.34 (95% confidence interval, 14.01-32.51), respectively. Median age at ovarian cancer diagnosis was 56 years (interquartile range, 49-63) for the endometriosis cohort and 60 years (interquartile range, 53-67) for the nevus cohort, (P < .05). After excluding women with less than 1 person-year at risk following an endometriosis diagnosis, we found a crude incidence rate ratio of 1.04 (95% confidence interval, 0.91-1.19) and an age-adjusted incidence rate ratio of 1.08 (95% confidence interval, 0.87-1.35) for ovarian cancer overall. However, statistically significant age-adjusted incidence rate ratios of 2.29 (95% confidence interval, 1.24-4.20) for clear-cell ovarian cancer and 2.56 (95% confidence interval, 1.47-4.47) for endometrioid ovarian cancer were found. CONCLUSION: A significantly higher incidence of clear-cell and endometrioid ovarian cancer was found in women with histologically proven endometriosis. Additionally, we found an increased incidence of all ovarian cancer subtypes in histologically proven endometriosis; however, in many of these women, endometriosis and ovarian cancer were diagnosed synchronously after the average menopausal age, which may suggest that the risk of ovarian cancer in endometriosis patients remains, even when clinical endometriosis symptoms are no longer present.
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Carcinoma Endometrioide/complicaciones , Carcinoma Endometrioide/epidemiología , Endometriosis/complicaciones , Neoplasias Ováricas/complicaciones , Neoplasias Ováricas/epidemiología , Anciano , Estudios de Cohortes , Endometriosis/patología , Femenino , Humanos , Incidencia , Persona de Mediana EdadRESUMEN
BACKGROUND: In women with abnormal uterine bleeding, fibroids are a frequent finding. In case of heavy menstrual bleeding and presence of submucosal type 0-1 fibroids, hysteroscopic resection is the treatment of first choice, as removal of these fibroids is highly effective. Hysteroscopic myomectomy is currently usually performed in the operating theatre. A considerable reduction in costs and a higher patient satisfaction are expected when procedural sedation and analgesia with propofol (PSA) in an outpatient setting is applied. However, both safety and effectiveness - including the necessity for re-intervention due to incomplete resection - have not yet been evaluated. METHODS: This study is a multicentre randomised controlled trial with a non-inferiority design and will be performed in the Netherlands. Women > 18 years with a maximum of 3 symptomatic type 0 or 1 submucosal fibroids with a maximum diameter of 3.5 cm are eligible to participate in the trial. After informed consent, 205 women will be randomised to either hysteroscopic myomectomy using procedural sedation and analgesia with propofol in an outpatient setting or hysteroscopic myomectomy using general anaesthesia in a clinical setting in the operating theatre. Primary outcome will be the percentage of complete resections, based on transvaginal ultrasonography 6 weeks postoperatively. Secondary outcomes are cost effectiveness, menstrual blood loss (Pictorial blood assessment chart), quality of life, pain, return to daily activities/work, hospitalization, (post) operative complications and re-interventions. Women will be followed up to one year after hysteroscopic myomectomy. DISCUSSION: This study may demonstrate comparable effectiveness of hysteroscopic myomectomy under procedural sedation and analgesia versus general anaesthesia in a safe and patient friendly environment, whilst achieving a significant cost reduction. TRIAL REGISTRATION: Dutch trial register, number NTR5357 . Registered 11th of August 2015.
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Analgesia/economía , Anestesia General/economía , Miomectomía Uterina/economía , Neoplasias Uterinas/economía , Neoplasias Uterinas/cirugía , Adulto , Analgesia/métodos , Anestesia General/métodos , Análisis Costo-Beneficio , Femenino , Humanos , Histeroscopía/economía , Laparotomía/economía , Persona de Mediana Edad , Países Bajos , Manejo del Dolor , Satisfacción del Paciente , Miomectomía Uterina/métodosRESUMEN
Female sterilization is the most popular and common contraceptive method worldwide. Because hysteroscopic sterilization techniques are used less often due to side effects, the number of laparoscopic sterilization is increasing. A systematic overview concerning the most optimal anesthetic technique for laparoscopic sterilization is lacking. We performed a systematic review to compare conscious sedation with general anesthesia for laparoscopic sterilization procedures with respect to clinical relevant outcome measures, such as operating times, perioperative parameters and complications, patient comfort, recovery, and patient satisfaction. We searched Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE for randomized controlled trials comparing general anesthesia with conscious sedation for laparoscopic sterilization. Two authors (AGH and HAAMvV) abstracted and entered data into RevMan. Methodologic quality of the included trials was critically appraised. For our main outcome measures mean differences (continuous variables) and risk ratios (dichotomous variables) with 95% confidence intervals using random-effect models were calculated. Four randomized controlled trials were included comparing general anesthesia versus local anesthesia with conscious sedation for laparoscopic sterilization. The methodologic quality of the studies was moderate to good. Both techniques were comparable with regard to operating times, complications, and postoperative pain. However, local anesthesia with conscious sedation showed better results compared with general anesthesia with respect to recovery times, patient complaints of sore throat, and patient recovery and satisfaction. In conclusion, this systematic review about anesthetic techniques for laparoscopic sterilization showed that both general anesthesia and conscious sedation have no major anesthetic complications and may therefore be safe. Patients might benefit from conscious sedation in terms of recovery times, sore throat, and patient recovery and satisfaction, but only a few studies are included in the review and are relatively old. New research regarding this subject is needed to advise our patients most optimally in the future about the best anesthetic technique to be used when choosing for a laparoscopic sterilization procedure.
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Anestesia General , Anestesia Local/métodos , Sedación Consciente/métodos , Laparoscopía/métodos , Esterilización Reproductiva/métodos , Femenino , Humanos , Tempo Operativo , Satisfacción del PacienteRESUMEN
STUDY OBJECTIVE: To compare polyp resection time and myoma resection rate using 2 hysteroscopic tissue removal systems. DESIGN: Prospective randomized in vitro trial (Canadian Task Force classification I). SETTING: Clinical skills laboratory of a non-university teaching hospital. SAMPLES: Polyp surrogate and myoma tissue. INTERVENTIONS: Hysteroscopic tissue removal with the TRUCLEAR system, using the TRUCLEAR INCISOR 2.9 (TI), TRUCLEAR INCISOR Plus (TIP), or TRUCLEAR ULTRA Plus (TUP) device, and the MyoSure system, using the MyoSure Lite (ML), MyoSure Classic (MC), or MyoSure XL (MXL) device. MEASUREMENTS AND MAIN RESULTS: Forty-two fragments of umbilical cord weighing 5 g, as a surrogate for polyps, were randomly allocated to 4 types of devices (TI, TIP, ML, and MC). Three consecutive fragments were removed using a single device. In addition, 18 pieces of myoma tissue were divided into 2 equal parts and randomly allocated to 2 types of devices (TUP and MXL). A new device was used for each fragment. Each type of device was tested at 2 vacuum settings. When removing 1 polyp, the TIP (median time, 2:33 minutes [interquartile range (IQR), 1:32-3:27 minutes]), the MC (median time, 3:15 minutes [IQR, 2:42-3:42 minutes]), and the ML (median time, 3:00 minutes [IQR, 2:16-3:25 minutes]) performed significantly faster than the TI (median time, 14:09 minutes [IQR, 13:44-14:36 minutes]), by 84%, 78%, and 82% respectively (p < .001). The TIP performed 80% faster than the TI (median time, 2:27 minutes [IQR, 1:45-2:46 minutes] vs 10:37 minutes [IQR, 8:38-13:44 minutes]; p < .001) when removing a second polyp. For removal of a third polyp, the TIP performed significantly faster (median time, 2:22 minutes [IQR, 1:32-3:07 minutes]) than the TI (median time, 8:35 minutes [IQR, 7:37-9:03 minutes]) and the ML (median time, 10:02 minutes [IQR, 9:51-10:18 minutes]), by 74% and 78%, respectively (p < .001). The performance of the ML decreased (p < .001) during removal of 3 consecutive tissue samples. For myoma tissue, the estimated mean resection rate of the TUP (2.96 g/min [95% confidence interval (CI), 2.32-3.77 g/min]) was 24% (95% CI 0.2%-52.4%) higher than the mean resection rate of the MXL (2.39 g/min [95% CI 1.87-3.05 g/min]; p = .048). The resection rate of the MXL adjusted for vacuum setting declined by 3% per unit increase in myoma volume (95% CI, -0.6% to -5.7%; p = .02). For the TUP, no linear association was found (0.4%; 95% CI, -2.1% to 3.0%; p = .72). CONCLUSION: In vitro comparison of the removal of surrogate polyps showed that although the larger TIP, MC, and ML devices were significantly faster than the TI for removal of 1 polyp, only the TIP was consistently faster than the TI for consecutive removal of polyps. The performance of the ML decreased significantly during removal of 3 consecutive tissue samples, making it slower than the TIP with a similar window size in the third run. For removal of myoma tissue, the resection rate of the TUP was significantly higher than that of the MXL, and the resection rate of the MXL decreased with increasing myoma volume. In vitro testing can provide useful information on the time and rate of hysteroscopic tissue removal.
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Técnicas de Ablación Endometrial/instrumentación , Histeroscopía/instrumentación , Pólipos/cirugía , Neoplasias Uterinas/cirugía , Competencia Clínica , Técnicas de Ablación Endometrial/métodos , Femenino , Humanos , Histeroscopía/métodos , Técnicas In Vitro , Mioma/cirugía , Distribución Aleatoria , Cordón Umbilical/patología , Cordón Umbilical/cirugíaRESUMEN
STUDY OBJECTIVE: To compare hysteroscopic morcellation with loop resection for the removal of placental remnants in terms of procedure time, adverse events, tissue availability, histology results, short-term effectiveness, and postoperative adhesions. DESIGN: A randomized controlled trial (Canadian Task Force classification I). SETTING: A teaching and university hospital. PATIENTS: Women with placental remnants. INTERVENTIONS: Hysteroscopic morcellation with the TRUCLEAR 8.0 Tissue Removal System (Smith & Nephew, Inc, Andover, MA) or loop resection with a rigid 8.5-mm bipolar resectoscope (Karl Storz GmbH, Tuttlingen, Germany). MEASUREMENTS AND MAIN RESULTS: Forty-six and 40 women were included in the hysteroscopic morcellation and resection groups, respectively. The median operating time was significantly shorter for hysteroscopic morcellation compared with loop resection (6.2 minutes [interquartile range, 4.0-11.2 minutes] vs 10.0 minutes [5.8-16.4 minutes], p = .023). Both operating time and total procedure time, corrected for the diameter of the placental remnants, were significantly reduced for hysteroscopic morcellation compared with loop resection, by 40% (95% confidence interval, 15%-58%; p = .005) and 22% (95% CI, 5%-37%; p = .014), respectively. No adverse events occurred during hysteroscopic removal. Perforation at dilation in 8 cases of the hysteroscopic morcellation group resulted in 2 procedure discontinuations and 1 incomplete procedure. Incomplete removal was found in 1 uncomplicated hysteroscopic morcellation procedure and 2 resection procedures. Pathology results confirmed the presence of placental remnants in 27 of 40 (67.5%) and 26 of 37 (70%) patients in the hysteroscopic morcellation and resection groups, respectively. Second-look hysteroscopy showed de novo intrauterine adhesions in 1 of 35 patients (3%) in the hysteroscopic morcellation group and 1 of 30 (3%) patients in the resection group. CONCLUSION: Hysteroscopic morcellation is a faster alternative than loop resection. Both techniques are safe and show high rates of complete removal and tissue availability and low rates of de novo intrauterine adhesions.
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Histeroscopía/métodos , Retención de la Placenta/cirugía , Adulto , Bélgica , Femenino , Hospitales Universitarios , Humanos , Morcelación/métodos , Países Bajos , Tempo Operativo , Complicaciones Posoperatorias , Embarazo , Resultado del TratamientoRESUMEN
BACKGROUND: Women who want to start intrauterine contraception (IUC) during the postpartum period might benefit from IUC insertion immediately after delivery. Postplacental insertion greatly reduces the risk of subsequent pregnancy and eliminates the need for a return visit to start contraception. Without the option of immediate insertion, many women may never return for services or may adopt less effective contraception. OBJECTIVES: Our aim was to examine the outcomes of IUC insertion immediately after placenta delivery (within 10 minutes), especially when compared with insertion at other postpartum times. We focused on successful IUC placement (insertion), subsequent expulsion, and method use. SEARCH METHODS: We searched for trials until 1 April 2015. Sources included PubMed (MEDLINE), the Cochrane Central Register of Controlled Trials (CENTRAL), POPLINE, Web of Science, EMBASE, LILACS, ClinicalTrials.gov, and ICTRP. For the original review, the authors contacted investigators to identify other trials. SELECTION CRITERIA: We sought randomized controlled trials (RCTs) with at least one treatment arm that involved immediate IUC placement (i.e., within 10 minutes of placenta delivery). Comparison arms could have included early postpartum insertion (from 10 minutes postplacental to hospital discharge) or standard insertion (during a postpartum visit). Trials could also have compared different IUC methods or insertion techniques. Delivery may have been vaginal or cesarean. Primary outcomes were placement (insertion), subsequent expulsion, and method use at study assessment. DATA COLLECTION AND ANALYSIS: For dichotomous outcomes, we used the Mantel-Haenszel odds ratio (OR) with 95% confidence interval (CI). Earlier studies primarily reported results as life-table rates. We aggregated trials in a meta-analysis if they had similar interventions and outcome measures. A sensitivity analysis included studies with moderate or high quality evidence and sufficient outcome data. MAIN RESULTS: We included 15 trials. Seven studies reported from 2010 to 2014 were added to eight from the original 2001 review. Newer trials compared immediate postplacental insertion versus early (10 minutes to 48 hours) or standard insertion (during the postpartum visit). Of four with full reports, three were small trials. The other three studies had conference abstracts. The eight early trials examined immediate insertion of different devices or insertion techniques. Most studies were published in the 1980s, some with limited reporting.Our sensitivity analysis included trials with sufficient outcome data and moderate or high quality evidence. Four newer trials comparing insertion times met the inclusion criteria. Two studies used the levonorgestrel-releasing intrauterine system (LNG-IUS) after vaginal delivery. The other two trials placed IUC after cesarean section; one used the CuT 380A intrauterine device (IUD) and the other used the LNG-IUS.A pilot trial compared immediate insertion versus early or standard insertion. In groups comparing immediate versus early insertion (N = 30), all women had the LNG-IUS inserted. By six months, the groups had the same expulsion rate and did not differ significantly in IUC use.For immediate versus standard insertion, we conducted meta-analyses of four trials. Insertion rates did not differ significantly between study arms. However, the trial from Uganda showed insertion was more likely for the immediate group, although the estimate was imprecise. In the meta-analysis, expulsion by six months was more likely for the immediate group, but the confidence interval was wide (OR 4.89, 95% CI 1.47 to 16.32; participants = 210; studies = 4). IUC use at six months was more likely with immediate insertion than with standard insertion (OR 2.04, 95% CI 1.01 to 4.09; participants = 243; studies = 4). Study arms did not differ in use at 3 or 12 months in individual small trials. AUTHORS' CONCLUSIONS: Recent trials compared different insertion times after vaginal or cesarean delivery. Evidence was limited because studies with full reports generally had small sample sizes. Overall, the quality of evidence was moderate; abstracts and older studies had limited reporting. Ongoing trials will add to the evidence, although some are small. Trials of adequate power are needed to estimate expulsion rates and side effects.The benefit of effective contraception immediately after delivery may outweigh the disadvantage of increased risk for expulsion. Frequent prenatal visits during the third trimester provide the opportunity to discuss effective contraceptive methods and desired timing for initiation. Clinical follow-up can help detect early expulsion, as can educating women about expulsion signs and symptoms.
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Anticoncepción de Barrera/métodos , Dispositivos Intrauterinos , Periodo Posparto , Anticoncepción de Barrera/instrumentación , Estudios de Factibilidad , Femenino , Humanos , Embarazo , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de TiempoRESUMEN
STUDY OBJECTIVES: To compare hysteroscopic morcellation with bipolar resectoscopy for removal of endometrial polyps, in terms of procedure time, peri- and postoperative adverse events, tissue availability, and short-term effectiveness. DESIGN: Multicenter, open label, randomized controlled trial (Canadian Task Force classification I). SETTING: Day surgery setting of a teaching and a university hospital. PATIENTS: Women with larger (≥1 cm) endometrial polyps. INTERVENTIONS: Hysteroscopic morcellation with the TRUCLEAR 8.0 Tissue Removal System or bipolar resectoscopy with a rigid 8.5-mm bipolar resectoscope. MEASUREMENTS AND MAIN RESULTS: Eighty-four women were included in the intention-to-treat analysis. Median operating time was 4.0 min (range: 2.5-7.1) and 6.0 min (range: 3.8-11.7) in the hysteroscopic morcellation and resectoscopy groups, respectively. Operating time was reduced by 38% (95% confidence interval: 5%-60%; p = .028) in the hysteroscopic morcellation group. Procedure time, which was defined as the sum of the installation and operating time, tended to be less for the hysteroscopic morcellation group (median 9.5 min [range: 7.6-12.2] vs 12.2 min [range: 8.8-16.0]; p = .072). Perforation occurred at dilation or hysteroscope (re)introduction in 3 patients of the resectoscopy group, resulting in procedure discontinuation or prolongation of hospital stay. Perforation occurred at dilation in 1 patient in the hysteroscopic morcellation group; however, the procedure was successfully completed. Postoperatively, 2 patients of the hysteroscopic morcellation group were diagnosed with a urinary tract infection. Tissue was available for pathology analysis in all patients, except for 2 patients in the resectoscopy group in whom the procedure was discontinued due to perforation. CONCLUSION: Hysteroscopic morcellation is a fast, effective, and safe alternative to bipolar resectoscopy for removal of endometrial polyps.
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Histeroscopía , Morcelación , Pólipos/cirugía , Neoplasias Uterinas/cirugía , Adulto , Bélgica/epidemiología , Electrocirugia/métodos , Femenino , Humanos , Histeroscopía/métodos , Persona de Mediana Edad , Morcelación/métodos , Países Bajos/epidemiología , Tempo Operativo , Embarazo , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide, including vas occlusion techniques (excision and ligation, thermal or electrocautery, and mechanical and chemical occlusion methods), as well as vasectomy with vas irrigation or with fascial interposition. Vasectomy guidelines largely rely on information from observational studies. Ideally, the choice of vasectomy techniques should be based on the evidence from randomized controlled trials (RCTs). OBJECTIVES: The objective of this review was to compare the effectiveness, safety, acceptability and costs of vasectomy techniques for male sterilization. SEARCH METHODS: In February 2014, we updated the searches of CENTRAL, MEDLINE, POPLINE and LILACS. We looked for recent clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform. Previous searches also included EMBASE. For the initial review, we searched the reference lists of relevant articles and book chapters. SELECTION CRITERIA: We included RCTs comparing vasectomy techniques, which could include suture ligature, surgical clips, thermal or electrocautery, chemical occlusion, vas plugs, vas excision, open-ended vas, fascial interposition, or vas irrigation. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts located in the literature searches. Two reviewers independently extracted data from articles identified for inclusion. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability. Peto odds ratios (OR) with 95% confidence intervals (CI) were used for dichotomous outcomes, such as azoospermia. The mean difference (MD) was used for the continuous variable of operating time. MAIN RESULTS: Six studies met the inclusion criteria. One trial compared vas occlusion with clips versus a conventional vasectomy technique. No difference was found in failure to reach azoospermia (no sperm detected). Three trials examined vasectomy with vas irrigation. Two studies looked at irrigation with water versus no irrigation, while one examined irrigation with water versus the spermicide euflavine. None found a difference between the groups for time to azoospermia. However, one trial reported that the median number of ejaculations to azoospermia was lower in the euflavine group compared to the water irrigation group. One high-quality trial compared vasectomy with fascial interposition versus vasectomy without fascial interposition. The fascial interposition group was less likely to have vasectomy failure. Fascial interposition had more surgical difficulties, but the groups were similar in side effects. Lastly, one trial found that an intra-vas was less likely to produce azoospermia than was no-scalpel vasectomy. More men were satisfied with the intra-vas device, however. AUTHORS' CONCLUSIONS: For vas occlusion with clips or vasectomy with vas irrigation, no conclusions can be made as those studies were of low quality and underpowered. Fascial interposition reduced vasectomy failure. An intra-vas device was less effective in reducing sperm count than was no-scalpel vasectomy. RCTs examining other vasectomy techniques were not available. More and better quality research is needed to examine vasectomy techniques.
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Vasectomía/métodos , Aminoacridinas , Humanos , Masculino , Oligospermia/etiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Espermicidas , Instrumentos Quirúrgicos , Irrigación Terapéutica , Conducto Deferente/cirugíaRESUMEN
BACKGROUND: Currently, the two most common surgical techniques for approaching the vas during vasectomy are the incisional method and the no-scalpel technique. Whereas the conventional incisional technique involves the use of a scalpel to make one or two incisions, the no-scalpel technique uses a sharp-pointed, forceps-like instrument to puncture the skin. The no-scalpel technique aims to reduce adverse events, especially bleeding, bruising, hematoma, infection and pain and to shorten the operating time. OBJECTIVES: The objective of this review was to compare the effectiveness, safety, and acceptability of the incisional versus no-scalpel approach to the vas. SEARCH METHODS: In February 2014, we searched the computerized databases of CENTRAL, MEDLINE, POPLINE and LILACS. We looked for recent clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform. Previous searches also included in EMBASE. For the initial review, we searched the reference lists of relevant articles and book chapters. SELECTION CRITERIA: Randomized controlled trials and controlled clinical trials were included in this review. No language restrictions were placed on the reporting of the trials. DATA COLLECTION AND ANALYSIS: We assessed all titles and abstracts located in the literature searches and two authors independently extracted data from the articles identified for inclusion. Outcome measures included safety, acceptability, operating time, contraceptive efficacy, and discontinuation. We calculated Peto odds ratios (OR) with 95% confidence intervals (CI) for the dichotomous variables. MAIN RESULTS: Two randomized controlled trials evaluated the no-scalpel technique and differed in their findings. The larger trial demonstrated less perioperative bleeding (OR 0.49; 95% CI 0.27 to 0.89) and pain during surgery (OR 0.75; 95% CI 0.61 to 0.93), scrotal pain (OR 0.63; 95% 0.50 to 0.80), and incisional infection (OR 0.21; 95% CI 0.06 to 0.78) during follow up than the standard incisional group. Both studies found less hematoma with the no-scalpel technique (OR 0.23; 95% CI 0.15 to 0.36). Operations using the no-scalpel approach were faster and had a quicker resumption of sexual activity. The smaller study did not find these differences; however, the study could have failed to detect differences due to a small sample size as well as a high loss to follow up. Neither trial found differences in vasectomy effectiveness between the two approaches to the vas. AUTHORS' CONCLUSIONS: The no-scalpel approach to the vas resulted in less bleeding, hematoma, infection, and pain as well as a shorter operation time than the traditional incision technique. No difference in effectiveness was found between the two approaches.
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Instrumentos Quirúrgicos , Vasectomía/métodos , Hemorragia/etiología , Humanos , Complicaciones Intraoperatorias/etiología , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Vasectomía/efectos adversos , Vasectomía/instrumentaciónRESUMEN
Objectives: Vaginal assisted Natural Orifice Transluminal Endoscopic Surgery (NOTES) combines the benefits of vaginal and endoscopic surgery. This study presents the results of the first vaginal assisted NOTES hysterectomies (VANH) in The Netherlands. Study design: A prospective cohort study was performed in two non-academic teaching hospitals in The Netherlands. Data was collected from patients who underwent a VANH for benign indications between August 2019 and April 2023. Baseline characteristics and data of intra- and postoperative surgical outcomes were recorded and analysed. The VANHs were performed by four experienced vaginal and endoscopic gynaecological surgeons. Results: A total of 200 patients underwent a VANH. Indications were dysfunctional menstrual bleeding (61 %; n = 122), abnormal cervical cytology (15.5 %; n = 31), abdominal pain (11.5 %; n = 23), post ablation/sterilization pain syndrome (3.5 %; n = 7), uterine fibroids (5.0 %; n = 10), atypical endometrial hyperplasia (2.5 %; n = 5) and Lynch or BRCA gene mutation carriers (1.0 %, n = 2). The mean surgical time was 61.4 min ( ± 22.8 min) with a mean blood loss of 88 mL ( ± 89 mL) and a mean uterine weight of 150 g ( ± 112 g). In 2.0 % (n = 4) of the cases a conversion was necessary. Same day discharge (SDD) was feasible in 80.2 % (n = 105) of the patients planned in day-care. In 2.0 % (n = 4) an intra-operative complication and in 9.0 % (n = 18) a post-operative complication occurred. Conclusion: This study shows vNOTES to be a safe and feasible surgical technique and can be safely implemented with appropriate patient selection and skilled surgeons. It highlights the importance of surgeon awareness of the challenges inherent in the initial stages of the implementation of a new surgical technique when performing their first vNOTES procedures. Additional randomized clinical trials are needed to show superiority of vNOTES compared to traditional surgery.
RESUMEN
BACKGROUND: Adequate contraceptive advice is important in both women with diabetes mellitus type 1 and type 2 to reduce the risk of maternal and infant morbidity and mortality in unplanned pregnancies. A wide variety of contraceptives are available for these women. However, hormonal contraceptives might influence carbohydrate and lipid metabolism and increase micro- and macrovascular complications, so caution in selecting a contraceptive method is required. OBJECTIVES: To investigate whether progestogen-only, combined estrogen and progestogen or non-hormonal contraceptives differ in terms of effectiveness in preventing pregnancy, in their side effects on carbohydrate and lipid metabolism, and in long-term complications such as micro- and macrovascular disease when used in women with diabetes mellitus. SEARCH METHODS: The search was performed in CENTRAL, MEDLINE, EMBASE, POPLINE, CINAHL, WorldCat, ECO, ArticleFirst, the Science Citation Index, the British Library Inside, and reference lists of relevant articles. The last search was performed in January 2013. In addition, experts in the field and pharmaceutical companies marketing contraceptives were contacted to identify published, unpublished or ongoing studies. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials that studied women with diabetes mellitus comparing: 1. hormonal versus non-hormonal contraceptives; 2. progestogen-only versus estrogen and progestogen contraceptives; 3. contraceptives containing < 50 µg estrogen versus contraceptives containing ≥ 50 µg estrogen; and 4. contraceptives containing first-, second- and third-generation progestogens, drospirenone and cyproterone acetate. The principal outcomes were contraceptive effectiveness, diabetes control, lipid metabolism and micro- and macrovascular complications. DATA COLLECTION AND ANALYSIS: Two investigators evaluated the titles and abstracts identified from the literature search. Quality assessment was performed independently with discrepancies resolved by discussion or consulting a third review author. Because the trials differed in studied contraceptives, participant characteristics and methodological quality, we could not combine the data in a meta-analysis. The trials were therefore examined on an individual basis and narrative summaries were provided. MAIN RESULTS: Four randomised controlled trials were included. No unintended pregnancies were reported during the study periods. Only one trial was of good methodological quality. It compared the influence of a levonorgestrel-releasing intrauterine device (IUD) versus a copper IUD on carbohydrate metabolism in women with type 1 diabetes mellitus. No significant difference was found between the two groups. The other three trials were of limited methodological quality. Two compared progestogen-only pills with different estrogen and progestogen combinations, and one also included the levonorgestrel-releasing IUD and copper IUD. The trials reported that blood glucose levels remained stable during treatment with most regimens. Only high-dose combined oral contraceptives and 30 µg ethinylestradiol + 75 µg gestodene were identified as slightly impairing glucose homeostasis. The three studies found conflicting results regarding lipid metabolism. Some combined oral contraceptives appeared to have a minor adverse effect while others appeared to slightly improve lipid metabolism. The copper IUD and progestogen-only oral contraceptives also slightly improved lipid metabolism and no influence was seen while using the levonorgestel-releasing IUD. Only one study reported on micro- and macrovascular complications. It observed no signs or symptoms of thromboembolic incidents or visual disturbances, however study duration was short. Only minor adverse effects were reported in two studies. AUTHORS' CONCLUSIONS: The four included randomised controlled trials in this systematic review provided insufficient evidence to assess whether progestogen-only and combined contraceptives differ from non-hormonal contraceptives in diabetes control, lipid metabolism and complications. Three of the four studies were of limited methodological quality, sponsored by pharmaceutical companies and described surrogate outcomes. Ideally, an adequately reported, high-quality randomised controlled trial analysing both intermediate outcomes (that is glucose and lipid metabolism) and true clinical endpoints (micro- and macrovascular disease) in users of combined, progestogen-only and non-hormonal contraceptives should be conducted. However, due to the low incidence of micro- and macrovascular disease and accordingly the large sample size and long follow-up period needed to observe differences in risk, a randomised controlled trial might not be the ideal design.
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Anticonceptivos Femeninos/administración & dosificación , Anticonceptivos Hormonales Orales/administración & dosificación , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 2/sangre , Progestinas/administración & dosificación , Glucemia/metabolismo , Anticonceptivos Femeninos/efectos adversos , Anticonceptivos Hormonales Orales/efectos adversos , Femenino , Homeostasis/efectos de los fármacos , Humanos , Dispositivos Intrauterinos Medicados , Levonorgestrel/administración & dosificación , Levonorgestrel/efectos adversos , Metabolismo de los Lípidos/efectos de los fármacos , Embarazo , Progestinas/efectos adversos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As an alternative, endometrial ablation is also very effective, but this treatment has to be performed by a gynaecologist. Due to lack of direct comparison of LNG-IUS with endometrial ablation, there is no evidence based preferred advice for the use of one of these treatment possibilities. METHOD/DESIGN: A multicenter randomised controlled trial, organised in a network infrastructure in the Netherlands in which general practitioners and gynaecologists collaborate. DISCUSSON: This study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding. TRIAL REGISTRATION: Dutch trial register, number NTR2984.