|- candidate number||1429|
|- NTR Number||NTR302|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Randomized controlled trial of treatment of endometrial polyps in case of postmenopausal bleeding.|
|- Scientific Title||Randomized controlled trial of treatment of endometrial polyps in case of postmenopausal bleeding.|
|- hypothesis||Resection of endometrial polyp(s) in women with postmenopausal bleeding and endometrial thickness of more than 4 mm will lead to less recurrent bleeding than in women in whom no resection is performed.|
|- Healt Condition(s) or Problem(s) studied||Endometrial polyps, Postmenopausal bleeding|
|- Inclusion criteria||Women with postmenopausal bleeding and endometrial thickness of more than 4 mm in whom an endometrial polyp is diagnosed during hysteroscopy.|
|- Exclusion criteria||Women with postmenopausal bleeding on tamoxifen treatment.|
Women with postmenopausal bleeding with (supsicion of) malignancy during hysteroscopy.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2005|
|- planned closingdate||1-sep-2007|
|- Target number of participants||60|
|- Interventions||Resection will take place in the same session in which the polyp is diagnosed. |
Resection is performed following standard procedures used in the residential hospital.
Resection of endometrial polyp is performed by the hysteroscopist using the instruments of his/her choice.
- In general smaller polyps (< 5 mm) will be resected using mechanical instruments.
- Larger polyps will be resected using electrosurgical material, i.e. the monopolar polypsnare in or the bipolar electrode.
The polyp is resected completely at its stalk. Resections can occur in more than one piece if necessary.
|- Primary outcome||The primary outcome measure is the recurrence of postmenopausal bleeding. |
|- Secondary outcome||Quality of life will be assessed using several standard self-administered psychometric measures with established reliability and validity. |
We will use the Short Form 36 (SF36), the State Trait Anxiety Score (STAI).
Moreover, patient satisfaction will be assessed using a VAS score.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| A. Timmermans|
|- CONTACT for SCIENTIFIC QUERIES|| A. Timmermans|
|- Sponsor/Initiator ||St. Antonius Hospital|
(Source(s) of Monetary or Material Support)
|- Brief summary||Introduction: |
The incidence of postmenopausal bleeding varies from 1.7- 14.6 per 1000 women, depending on age. The chance to find an endometrial carincoma in women with postmenopausal bleeding varies between 1% and 24%, and is also dependent on age.
The prevalence of endometrial polyps in women with postmenopausal bleeding and an endometrium thickness of 5 mm or more is estimated to be 41%.
The Dutch guideline for diagnostics in case of abnormal vaginal bleeding in postmenopausal womenfocuses on diagnosing malignant pathology of the endometrium.
The guideline uses endometrium thickness as a first screening tool to exclude cancer. Only in case the bleeding persists, a hysteroscopy is advised to diagnose benign treatable pathology.
No data exists either about the recurrence of bleeding in women with postmenopausal bleeding in whom an endometrial polyp is diagnosed. Simple polypectomy is known to lead to subjective improvement in symptoms of bleeding and high satisfaction rates. However, no data exists where polypectomy is compared with expectant management prospectively.
The primary objective of the proposed study is to answer the question whether endometrial polyps in women with postmenopausal bleeding should be treated when malignancy has been excluded.
A randomized controlled trial regarding resection of endometrial polyps in women with postmenopausal bleeding.
Resection will take place in the same session in which the polyp is diagnosed. Resection is performed following standard procedures used in the residential hospital.
In patients that are randomized for expectant management a sham resection procedure will be performed during 5 minutes.
Primary outcome measures:
The primary outcome measure is the recurrence of postmenopausal bleeding.
The primary end point will be recurrence of postmenopausal beelding. Time to recurence of postmenopausal bleeding will be assessed using Kaplan-Meier analysis.
In the intervention group and the control group, time to recurence of postmenopausal bleeding will be compared using the Log Rank test.
The difference between the two groups will be made explicit by calculating a relative risk and 95% confidence interval. Complications, pain (measured on VAS-scale), quality of life and costs will compared using the appropriate statistical tests.
The recurrence of posmenopausal bleeding in case of an endometrial polyp is assumed to be 85% after 6 months.
In case a polyp is resected, we expect the probability of recurrence of bleeding to be 35%. In view of these assumptions, and using a two-sided test with conventional characteristics (alpha-error 5%, beta-error 20%), we need 60 patients to be randomised to the two arms of the study.
|- Main changes (audit trail)|
|- RECORD||11-sep-2005 - 5-jan-2010|