Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH)

a parallel-group, open-label, randomised controlled trial

Kevin Cooper* (Corresponding Author), Suzanne Breeman, Neil W Scott, Graham Scotland, Justin Clark, Jed Hawe, Robert Hawthorn, Kevin Phillips, Graeme Stewart MacLennan, Samantha Wileman, Kirsty McCormack, Rodolfo Andrés Hernández, John Norrie, Siladitya Bhattacharya, HEALTH Study Group

*Corresponding author for this work

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background Heavy menstrual bleeding affects 25% of women in the UK, many of whom require surgery to treat it. Hysterectomy is effective but has more complications than endometrial ablation, which is less invasive but ultimately leads to hysterectomy in 20% of women. We compared laparoscopic supracervical hysterectomy with endometrial ablation in women seeking surgical treatment for heavy menstrual bleeding. Methods In this parallel-group, multicentre, open-label, randomised controlled trial in 31 hospitals in the UK, women younger than 50 years who were referred to a gynaecologist for surgical treatment of heavy menstrual bleeding and who were eligible for endometrial ablation were randomly allocated (1:1) to either laparoscopic supracervical hysterectomy or second generation endometrial ablation. Women were randomly assigned by either an interactive voice response telephone system or an internet-based application with a minimisation algorithm based on centre and age group (<40 years vs ≥40 years). Laparoscopic supracervical hysterectomy involves laparoscopic (keyhole) surgery to remove the upper part of the uterus (the body) containing the endometrium. Endometrial ablation aims to treat heavy menstrual bleeding by destroying the endometrium, which is responsible for heavy periods. The co-primary clinical outcomes were patient satisfaction and condition-specific quality of life, measured with the menorrhagia multi-attribute quality of life scale (MMAS), assessed at 15 months after randomisation. Our analysis was based on the intention-to-treat principle. The trial was registered with the ISRCTN registry, number ISRCTN49013893. Findings Between May 21, 2014, and March 28, 2017, we enrolled and randomly assigned 660 women (330 in each group). 616 (93%) of 660 women were operated on within the study period, 588 (95%) of whom received the allocated procedure and 28 (5%) of whom had an alternative surgery. At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97%] of 278 women vs 244 [87%] of 280 women; adjusted percentage difference 9·8, 95% CI 5·1–14·5; adjusted odds ratio [OR] 2·53, 95% CI 1·83–3·48; p<0·0001). Women randomly assigned to laparoscopic supracervical hysterectomy were also more likely to have the best possible MMAS score of 100 than women assigned to endometrial ablation (180 [69%] of 262 women vs 146 [54%] of 268 women; adjusted percentage difference 13·3, 95% CI 3·8–22·8; adjusted OR 1·87, 95% CI 1·31–2·67; p=0·00058). 14 (5%) of 309 women in the laparoscopic supracervical hysterectomy group and 11 (4%) of 307 women in the endometrial ablation group had at least one serious adverse event (adjusted OR 1·30, 95% CI 0·56–3·02; p=0·54). Interpretation Laparoscopic supracervical hysterectomy is superior to endometrial ablation in terms of clinical effectiveness and has a similar proportion of complications, but takes longer to perform and is associated with a longer recovery.
Original languageEnglish
Pages (from-to)1425-1436
Number of pages12
JournalThe Lancet
Volume394
Issue number10207
Early online date12 Sep 2019
DOIs
Publication statusPublished - 19 Oct 2019

Fingerprint

Endometrial Ablation Techniques
Hysterectomy
Randomized Controlled Trials
Hemorrhage
Menorrhagia
Odds Ratio
Quality of Life
Random Allocation
Endometrium

Keywords

  • MENORRHAGIA
  • RESECTION
  • BURDEN

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{20b3fd846e084603beaf87c88732a17a,
title = "Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial",
abstract = "Background Heavy menstrual bleeding affects 25{\%} of women in the UK, many of whom require surgery to treat it. Hysterectomy is effective but has more complications than endometrial ablation, which is less invasive but ultimately leads to hysterectomy in 20{\%} of women. We compared laparoscopic supracervical hysterectomy with endometrial ablation in women seeking surgical treatment for heavy menstrual bleeding. Methods In this parallel-group, multicentre, open-label, randomised controlled trial in 31 hospitals in the UK, women younger than 50 years who were referred to a gynaecologist for surgical treatment of heavy menstrual bleeding and who were eligible for endometrial ablation were randomly allocated (1:1) to either laparoscopic supracervical hysterectomy or second generation endometrial ablation. Women were randomly assigned by either an interactive voice response telephone system or an internet-based application with a minimisation algorithm based on centre and age group (<40 years vs ≥40 years). Laparoscopic supracervical hysterectomy involves laparoscopic (keyhole) surgery to remove the upper part of the uterus (the body) containing the endometrium. Endometrial ablation aims to treat heavy menstrual bleeding by destroying the endometrium, which is responsible for heavy periods. The co-primary clinical outcomes were patient satisfaction and condition-specific quality of life, measured with the menorrhagia multi-attribute quality of life scale (MMAS), assessed at 15 months after randomisation. Our analysis was based on the intention-to-treat principle. The trial was registered with the ISRCTN registry, number ISRCTN49013893. Findings Between May 21, 2014, and March 28, 2017, we enrolled and randomly assigned 660 women (330 in each group). 616 (93{\%}) of 660 women were operated on within the study period, 588 (95{\%}) of whom received the allocated procedure and 28 (5{\%}) of whom had an alternative surgery. At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97{\%}] of 278 women vs 244 [87{\%}] of 280 women; adjusted percentage difference 9·8, 95{\%} CI 5·1–14·5; adjusted odds ratio [OR] 2·53, 95{\%} CI 1·83–3·48; p<0·0001). Women randomly assigned to laparoscopic supracervical hysterectomy were also more likely to have the best possible MMAS score of 100 than women assigned to endometrial ablation (180 [69{\%}] of 262 women vs 146 [54{\%}] of 268 women; adjusted percentage difference 13·3, 95{\%} CI 3·8–22·8; adjusted OR 1·87, 95{\%} CI 1·31–2·67; p=0·00058). 14 (5{\%}) of 309 women in the laparoscopic supracervical hysterectomy group and 11 (4{\%}) of 307 women in the endometrial ablation group had at least one serious adverse event (adjusted OR 1·30, 95{\%} CI 0·56–3·02; p=0·54). Interpretation Laparoscopic supracervical hysterectomy is superior to endometrial ablation in terms of clinical effectiveness and has a similar proportion of complications, but takes longer to perform and is associated with a longer recovery.",
keywords = "MENORRHAGIA, RESECTION, BURDEN",
author = "Kevin Cooper and Suzanne Breeman and Scott, {Neil W} and Graham Scotland and Justin Clark and Jed Hawe and Robert Hawthorn and Kevin Phillips and MacLennan, {Graeme Stewart} and Samantha Wileman and Kirsty McCormack and Hern{\'a}ndez, {Rodolfo Andr{\'e}s} and John Norrie and Siladitya Bhattacharya and {HEALTH Study Group}",
note = "UK National Institute for Health Research Health Technology Assessment Programme.",
year = "2019",
month = "10",
day = "19",
doi = "10.1016/S0140-6736(19)31790-8",
language = "English",
volume = "394",
pages = "1425--1436",
journal = "The Lancet",
issn = "0140-6736",
publisher = "ACADEMIC PRESS INC ELSEVIER SCIENCE",
number = "10207",

}

TY - JOUR

T1 - Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH)

T2 - a parallel-group, open-label, randomised controlled trial

AU - Cooper, Kevin

AU - Breeman, Suzanne

AU - Scott, Neil W

AU - Scotland, Graham

AU - Clark, Justin

AU - Hawe, Jed

AU - Hawthorn, Robert

AU - Phillips, Kevin

AU - MacLennan, Graeme Stewart

AU - Wileman, Samantha

AU - McCormack, Kirsty

AU - Hernández, Rodolfo Andrés

AU - Norrie, John

AU - Bhattacharya, Siladitya

AU - HEALTH Study Group

N1 - UK National Institute for Health Research Health Technology Assessment Programme.

PY - 2019/10/19

Y1 - 2019/10/19

N2 - Background Heavy menstrual bleeding affects 25% of women in the UK, many of whom require surgery to treat it. Hysterectomy is effective but has more complications than endometrial ablation, which is less invasive but ultimately leads to hysterectomy in 20% of women. We compared laparoscopic supracervical hysterectomy with endometrial ablation in women seeking surgical treatment for heavy menstrual bleeding. Methods In this parallel-group, multicentre, open-label, randomised controlled trial in 31 hospitals in the UK, women younger than 50 years who were referred to a gynaecologist for surgical treatment of heavy menstrual bleeding and who were eligible for endometrial ablation were randomly allocated (1:1) to either laparoscopic supracervical hysterectomy or second generation endometrial ablation. Women were randomly assigned by either an interactive voice response telephone system or an internet-based application with a minimisation algorithm based on centre and age group (<40 years vs ≥40 years). Laparoscopic supracervical hysterectomy involves laparoscopic (keyhole) surgery to remove the upper part of the uterus (the body) containing the endometrium. Endometrial ablation aims to treat heavy menstrual bleeding by destroying the endometrium, which is responsible for heavy periods. The co-primary clinical outcomes were patient satisfaction and condition-specific quality of life, measured with the menorrhagia multi-attribute quality of life scale (MMAS), assessed at 15 months after randomisation. Our analysis was based on the intention-to-treat principle. The trial was registered with the ISRCTN registry, number ISRCTN49013893. Findings Between May 21, 2014, and March 28, 2017, we enrolled and randomly assigned 660 women (330 in each group). 616 (93%) of 660 women were operated on within the study period, 588 (95%) of whom received the allocated procedure and 28 (5%) of whom had an alternative surgery. At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97%] of 278 women vs 244 [87%] of 280 women; adjusted percentage difference 9·8, 95% CI 5·1–14·5; adjusted odds ratio [OR] 2·53, 95% CI 1·83–3·48; p<0·0001). Women randomly assigned to laparoscopic supracervical hysterectomy were also more likely to have the best possible MMAS score of 100 than women assigned to endometrial ablation (180 [69%] of 262 women vs 146 [54%] of 268 women; adjusted percentage difference 13·3, 95% CI 3·8–22·8; adjusted OR 1·87, 95% CI 1·31–2·67; p=0·00058). 14 (5%) of 309 women in the laparoscopic supracervical hysterectomy group and 11 (4%) of 307 women in the endometrial ablation group had at least one serious adverse event (adjusted OR 1·30, 95% CI 0·56–3·02; p=0·54). Interpretation Laparoscopic supracervical hysterectomy is superior to endometrial ablation in terms of clinical effectiveness and has a similar proportion of complications, but takes longer to perform and is associated with a longer recovery.

AB - Background Heavy menstrual bleeding affects 25% of women in the UK, many of whom require surgery to treat it. Hysterectomy is effective but has more complications than endometrial ablation, which is less invasive but ultimately leads to hysterectomy in 20% of women. We compared laparoscopic supracervical hysterectomy with endometrial ablation in women seeking surgical treatment for heavy menstrual bleeding. Methods In this parallel-group, multicentre, open-label, randomised controlled trial in 31 hospitals in the UK, women younger than 50 years who were referred to a gynaecologist for surgical treatment of heavy menstrual bleeding and who were eligible for endometrial ablation were randomly allocated (1:1) to either laparoscopic supracervical hysterectomy or second generation endometrial ablation. Women were randomly assigned by either an interactive voice response telephone system or an internet-based application with a minimisation algorithm based on centre and age group (<40 years vs ≥40 years). Laparoscopic supracervical hysterectomy involves laparoscopic (keyhole) surgery to remove the upper part of the uterus (the body) containing the endometrium. Endometrial ablation aims to treat heavy menstrual bleeding by destroying the endometrium, which is responsible for heavy periods. The co-primary clinical outcomes were patient satisfaction and condition-specific quality of life, measured with the menorrhagia multi-attribute quality of life scale (MMAS), assessed at 15 months after randomisation. Our analysis was based on the intention-to-treat principle. The trial was registered with the ISRCTN registry, number ISRCTN49013893. Findings Between May 21, 2014, and March 28, 2017, we enrolled and randomly assigned 660 women (330 in each group). 616 (93%) of 660 women were operated on within the study period, 588 (95%) of whom received the allocated procedure and 28 (5%) of whom had an alternative surgery. At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97%] of 278 women vs 244 [87%] of 280 women; adjusted percentage difference 9·8, 95% CI 5·1–14·5; adjusted odds ratio [OR] 2·53, 95% CI 1·83–3·48; p<0·0001). Women randomly assigned to laparoscopic supracervical hysterectomy were also more likely to have the best possible MMAS score of 100 than women assigned to endometrial ablation (180 [69%] of 262 women vs 146 [54%] of 268 women; adjusted percentage difference 13·3, 95% CI 3·8–22·8; adjusted OR 1·87, 95% CI 1·31–2·67; p=0·00058). 14 (5%) of 309 women in the laparoscopic supracervical hysterectomy group and 11 (4%) of 307 women in the endometrial ablation group had at least one serious adverse event (adjusted OR 1·30, 95% CI 0·56–3·02; p=0·54). Interpretation Laparoscopic supracervical hysterectomy is superior to endometrial ablation in terms of clinical effectiveness and has a similar proportion of complications, but takes longer to perform and is associated with a longer recovery.

KW - MENORRHAGIA

KW - RESECTION

KW - BURDEN

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VL - 394

SP - 1425

EP - 1436

JO - The Lancet

JF - The Lancet

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