Objective
To evaluate the effectiveness of hysteroscopy for the detection and treatment of endometrial polyps versus expectant management in women with postmenopausal bleeding (PMB), a thickened ...endometrium and benign endometrial sampling.
Design
Multicentre, randomised controlled trial.
Setting
Three academic hospitals and nine non‐academic teaching hospitals in the Netherlands.
Population
Women with PMB, an endometrial thickness >4 mm and benign result from endometrial sampling.
Methods
Women were randomised to either further diagnostic workup by hysteroscopy (preceded by saline infusion sonography) or expectant management.
Main outcomes
The primary outcome measure was recurrence of PMB within a year after randomisation. Secondary outcome measures were time to recurrent bleeding and recurrent bleeding after more than 1 year. In the hysteroscopy group, the presence of polyps and the results of their histology were registered.
Results
Between January 2010 and October 2013, 200 women were randomised; 98 to hysteroscopy and 102 to expectant management. Within 1 year a total of 15 women (15.3%) in the hysteroscopy group experienced recurrent bleeding, versus 18 (18.0%) in the expectant management group (relative risk 0.85 (95% CI 0.46–1.59). In the hysteroscopy group, 50/98 (51%) polyps were diagnosed of which 6/98 (6%) showed evidence of endometrial (pre)malignancy; final pathology results after hysterectomy showed three women with hyperplasia with atypia and three women with endometrial cancer.
Conclusion
In women with PMB, a thickened endometrium and benign endometrial sampling, operative hysteroscopy does not reduce recurrent bleeding. Hysteroscopy detected focal endometrial (pre)malignancy in 6% of women who had benign endometrial sampling. This finding indicates that in these women, further diagnostic workup is warranted to detect focal (pre)malignancies, missed by blind endometrial sampling.
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In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.
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In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
Objective
To compare recurrence of a cyst or abscess of the Bartholin gland after surgical treatment using a Word catheter or marsupialisation.
Design
Multicentre, open‐label, randomised controlled ...trial.
Setting
Eighteen hospitals in the Netherlands and one hospital in England.
Population
Women with a symptomatic cyst or abscess of the Bartholin gland.
Methods
Women were randomised to treatment with Word catheter or marsupialisation.
Main outcome measures
The primary outcome was recurrence of the cyst or abscess within 1 year of treatment. The secondary outcomes included pain during and after treatment (measured on a 10‐point scale), use of analgesics, and time from diagnosis to treatment. Analysis was by intention‐to‐treat. To assess whether marsupialisation would reduce the recurrence rate by 5% (from 20 to 15%) we needed to include 160 women (alpha error 0.05, beta error 0.2).
Results
One hundred and sixty‐one women were randomly allocated to treatment by Word catheter (n = 82) or marsupialisation (n = 79) between August 2010 and May 2014. Baseline characteristics were comparable. Recurrence occurred in 10 women (12%) allocated to Word catheter versus eight women (10%) allocated to marsupialisation: relative risk (RR) 1.1, 95% confidence interval (CI) 0.64–1.91; P = 0.70. Pain scores after treatment were also comparable. In the first 24 hours after treatment, 33% used analgesics in the Word catheter group versus 74% in the marsupialisation group (P < 0.001). Time from diagnosis to treatment was 1 hour for placement of Word catheter versus 4 hours for marsupialisation (P = 0.001).
Conclusions
In women with an abscess or cyst of the Bartholin gland, treatment with Word catheter and marsupialisation results in comparable recurrence rates.
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Comparable recurrence rates for treatment of Bartholinic abscess/cyst with Word catheter and marsupialisation.
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Comparable recurrence rates for treatment of Bartholinic abscess/cyst with Word catheter and marsupialisation.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
STUDY QUESTION
Is curettage more effective than expectant management in case of an incomplete evacuation after misoprostol treatment for first trimester miscarriage?
SUMMARY ANSWER
Curettage leads to ...a higher chance of complete evacuation but expectant management is successful in at least 76% of women with an incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.
WHAT IS KNOWN ALREADY
In 5–50% of the women treated with misoprostol, there is a suspicion of incomplete evacuation of the uterus on sonography. Although these women generally have minor symptoms, such a finding often leads to additional curettage.
STUDY DESIGN, SIZE, DURATION
From June 2012 until July 2014, we conducted a nationwide multicenter randomized controlled trial (RCT). Women who had had primary misoprostol treatment for miscarriage with sonographic evidence of incomplete evacuation of the uterus were randomly allocated to either curettage or expectant management (1:1), using a web-based application.
PARTICIPANTS/MATERIALS, SETTING, METHODS
We included 59 women in 27 hospitals; 30 were allocated to curettage and 29 were allocated to expectant management. A successful outcome was defined as sonographic finding of an empty uterus 6 weeks after randomization.
MAIN RESULTS AND THE ROLE OF CHANCE
Baseline characteristics of both groups were comparable. Empty uterus on sonography or uneventful clinical follow-up was seen in 29/30 women (97%) allocated to curettage compared with 22/29 women (76%) allocated to expectant management (RR 1.3, 95% CI 1.03–1.6) with complication rates of 10% versus 10%, respectively (RR 0.97, 95% CI 0.21–4.4). In the group allocated to curettage, no woman required re-curettage, while two women (6.7%) underwent hysteroscopy (for other or unknown reasons). In the women allocated to expectant management, curettage was performed in four women (13.8%) and three women (10.3%) underwent hysteroscopy.
LIMITATIONS, REASONS FOR CAUTION
Due to a strong patient preference, mainly for expectant management, the targeted sample size could not be included and the trial was stopped prematurely.
WIDER IMPLICATIONS OF THE FINDINGS
In women suspected of incomplete evacuation of the uterus after misoprostol, curettage is more effective than expectant management. However, expectant management is equally safe and prevents curettage for most of the women. This finding could further restrain the use of curettage in the treatment of first trimester miscarriage.
STUDY FUNDING/COMPETING INTEREST(S)
This study was funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-82310-97-12066. There were no conflicts of interests.
TRIAL REGISTRATION NUMBER
Dutch Trial Register NTR3310, http://www.trialregister.nl
TRIAL REGISTRATION DATE
27 February 2012.
DATE OF FIRST PATIENT'S ENROLMENT
12 June 2012.
(Abstracted from BJOG 2017;124:243–249)There is a 2% lifetime risk among women of developing a cyst or abscess of the Bartholin gland. These usually occur during reproductive ages; both can limit ...activity, and an abscess can also cause extreme pain.
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.
A multicenter randomised controlled trial, organised in a network infrastructure in the Netherlands in which general practitioners and gynaecologists collaborate.
This study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding.
Dutch trial register, number NTR2984.
Full text
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IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, UL, UM, UPUK, VSZLJ
Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation ...of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol.
The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization.Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients' quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry.
This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.
Dutch Trial Register: NTR3110.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
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. Women greater than or equai to 34 years with heavy menstrual bleeding, a Pictorial Blood Assessment Chart (PBAC) score exceeding 150 points and no future child wish can participate in the trial. After informed consent, women will be randomised to a strategy starting with a levonorgestrel releasing intrauterine system or a strategy starting with endometrial ablation. The primary outcome is the PBAC score at 24 months of follow-up. Secondary outcomes are patient satisfaction, complications, number of re-interventions, menstrual bleeding pattern, quality of life, sexual function, sick leave and costs. As predictors of effect of intervention we also meaure level of coagulation factors. 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 Keywords: Heavy menstrual bleeding, Endometrial ablation, LNG-IUS
Full text
Available for:
IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, UL, UM, UPUK, VSZLJ
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