Diagnostic workup for postmenopausal bleeding: a randomised controlled trial

N van Hanegem; M C Breijer; S A Slockers; M H Zafarmand; Pmaj Geomini; R Catshoek; Jma Pijnenborg; L F van der Voet; Fphlj Dijkhuizen; Gcr van Hoecke; N Reesink-Peters; S Veersema; Mha van Hooff; Pjm van Kesteren; J A Huirne; B C Opmeer; M Y Bongers; Bwj Mol; A Timmermans

doi:10.1111/1471-0528.14126

Diagnostic workup for postmenopausal bleeding: a randomised controlled trial

N van Hanegem, M C Breijer, S A Slockers, M H Zafarmand, Pmaj Geomini, R Catshoek, Jma Pijnenborg, L F van der Voet, Fphlj Dijkhuizen, Gcr van Hoecke, N Reesink-Peters, S Veersema, Mha van Hooff, Pjm van Kesteren, J A Huirne, B C Opmeer, M Y Bongers, Bwj Mol, A Timmermans

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

TWEETABLE ABSTRACT: In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.

Original language	English
Pages (from-to)	231-240
Number of pages	10
Journal	BJOG: An International Journal of Obstetrics & Gynaecology
Volume	124
Issue number	2
DOIs	https://doi.org/10.1111/1471-0528.14126
Publication status	Published - Jan 2017

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10.1111/1471-0528.14126

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van Hanegem, N., Breijer, M. C., Slockers, S. A., Zafarmand, M. H., Geomini, P., Catshoek, R., Pijnenborg, J., van der Voet, L. F., Dijkhuizen, F., van Hoecke, G., Reesink-Peters, N., Veersema, S., van Hooff, M., van Kesteren, P., Huirne, J. A., Opmeer, B. C., Bongers, M. Y., Mol, B., & Timmermans, A. (2017). Diagnostic workup for postmenopausal bleeding: a randomised controlled trial. BJOG: An International Journal of Obstetrics & Gynaecology, 124(2), 231-240. https://doi.org/10.1111/1471-0528.14126

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abstract = "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.TWEETABLE ABSTRACT: In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.",

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author = "{van Hanegem}, N and Breijer, {M C} and Slockers, {S A} and Zafarmand, {M H} and Pmaj Geomini and R Catshoek and Jma Pijnenborg and {van der Voet}, {L F} and Fphlj Dijkhuizen and {van Hoecke}, Gcr and N Reesink-Peters and S Veersema and {van Hooff}, Mha and {van Kesteren}, Pjm and Huirne, {J A} and Opmeer, {B C} and Bongers, {M Y} and Bwj Mol and A Timmermans",

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doi = "10.1111/1471-0528.14126",

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van Hanegem, N, Breijer, MC, Slockers, SA, Zafarmand, MH, Geomini, P, Catshoek, R, Pijnenborg, J, van der Voet, LF, Dijkhuizen, F, van Hoecke, G, Reesink-Peters, N, Veersema, S, van Hooff, M, van Kesteren, P, Huirne, JA, Opmeer, BC, Bongers, MY, Mol, B & Timmermans, A 2017, 'Diagnostic workup for postmenopausal bleeding: a randomised controlled trial', BJOG: An International Journal of Obstetrics & Gynaecology, vol. 124, no. 2, pp. 231-240. https://doi.org/10.1111/1471-0528.14126

TY - JOUR

T1 - Diagnostic workup for postmenopausal bleeding

T2 - a randomised controlled trial

AU - van Hanegem, N

AU - Breijer, M C

AU - Slockers, S A

AU - Zafarmand, M H

AU - Geomini, Pmaj

AU - Catshoek, R

AU - Pijnenborg, Jma

AU - van der Voet, L F

AU - Dijkhuizen, Fphlj

AU - van Hoecke, Gcr

AU - Reesink-Peters, N

AU - Veersema, S

AU - van Hooff, Mha

AU - van Kesteren, Pjm

AU - Huirne, J A

AU - Opmeer, B C

AU - Bongers, M Y

AU - Mol, Bwj

AU - Timmermans, A

PY - 2017/1

Y1 - 2017/1

N2 - 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.TWEETABLE ABSTRACT: In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.

AB - 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.TWEETABLE ABSTRACT: In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.

KW - Journal Article

U2 - 10.1111/1471-0528.14126

DO - 10.1111/1471-0528.14126

M3 - Article

C2 - 27225535

VL - 124

SP - 231

EP - 240

JO - BJOG: An International Journal of Obstetrics & Gynaecology

JF - BJOG: An International Journal of Obstetrics & Gynaecology

SN - 1470-0328

IS - 2

ER -