Uterine-Artery Embolization or Myomectomy for Uterine Fibroids.

Adult Female Humans Hysteroscopy Intention to Treat Analysis Intraoperative Complications Laparoscopy Leiomyoma / surgery Length of Stay Menorrhagia Middle Aged Ovarian Reserve Postoperative Complications Quality of Life Reoperation / statistics & numerical data Uterine Artery Embolization / adverse effects Uterine Myomectomy / adverse effects Uterine Neoplasms / surgery Uterus / surgery

Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
30 07 2020
Historique:
entrez: 30 7 2020
pubmed: 30 7 2020
medline: 18 8 2020
Statut: ppublish

Résumé

Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options. We conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score. A total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P = 0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group. Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.).

Sections du résumé

BACKGROUND
Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options.
METHODS
We conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score.
RESULTS
A total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P = 0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group.
CONCLUSIONS
Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.).

Identifiants

DOI: 10.1056/NEJMoa1914735 PMID: 32726530
pubmed: 32726530
doi: 10.1056/NEJMoa1914735
doi:

Banques de données

ISRCTN
['ISRCTN70772394']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

440-451

Subventions

Organisme : Chief Scientist Office
ID : TCS/17/25
Pays : United Kingdom
Organisme : Health Technology Assessment Programme
ID : 08/52/22
Pays : International

Investigateurs

Lakshmi Ratnam (L)
Leto Mailli (L)
Jocelyn Nocerino (J)
Tabindah Khan (T)
Elizabeth Cruddas (E)
Raj Das (R)
Seyed Renani (S)
Sivanathan Chandramohan (S)
Iain Robertson (I)
Karen Duffy (K)
Grant Urquhart (G)
Ganesh Ananthakrishnan (G)
Lorraine McGregor (L)
Ibraheem Hamoodi (I)
Isobel Crawford (I)
Lorna McKay (L)
Cecilia Lyons (C)
Brian Brady (B)
Jennifer Devlin (J)
Christine West (C)
Susan Ingram (S)
Andrew Horne (A)
Leye Thompson (L)
Nissanka Madipola (N)
Annemarie McGregor (A)
Rebecca Murray (R)
Kumar Kunde (K)
Julia Kopeika (J)
Yakoub Khalaf (Y)
Janice Rymer (J)
Rajesh Varma (R)
Irfan Ahmed (I)
Joseph Mechery (J)
Guida Kurzer (G)
Tarun Sabharwal (T)
Christian Becker (C)
Mark Bratby (M)
Raman Uberoi (R)
Vikram S Rai (VS)
Susan Anthony (S)
Stephen Kennedy (S)
Nicola Higgins (N)
Miriam Wilmott-Powell (M)
Janesh Gupta (J)
Arri Coomarasamy (A)
Manjeet Shehmar (M)
Yousri M M Afifi (YMM)
Justin Clark (J)
Shanteela McCooty (S)
Diane Mellers (D)
Shirin Irani (S)
Paul M Crowe (PM)
Andrew Willis (A)
Robert Jones (R)
Sarah Manney (S)
Fiona Kinney (F)
Sylvia Turner (S)
Heather Barrows (H)
Shagaf Bakour (S)
Joe Kabukoba (J)
Ket Tai (K)
Abha Sinha (A)
R Kristina A Naidoo (RKA)
Leroy Edozien (L)
Nick Chalmers (N)
Mandy Hockey (M)
Anantha-Krishnan Ganapathy (AK)
Finn Farquharson (F)
Rebecca Leech (R)
Hannah Phillips (H)
Lucy Dwyer (L)
Nicola Smith (N)
Gerry Murphy (G)
Linda Green (L)
Julie Melville (J)
Stephanie Bateman (S)
Sharon Kerrison (S)
Ranee Thakar (R)
Abdul Sultan (A)
Bini Ajay (B)
Michael Chang (M)
David Sarma (D)
Rebecca Byrne (R)
Ajeet Kumar (A)
James Park Yuen Lay (J)
Mark Willett (M)
Sujatha Anand (S)
Susan Gardiner (S)
Mark Roberts (M)
David Richardson (D)
Alison Kimber (A)
Tony Chalhoub (T)
Menem Yossry (M)
Jemma Fenwick (J)
Eileen Walton (E)
Patricia Wake (P)
Denise Milford (D)
Gill Campbell (G)
Karen Armstrong (K)
Victoria Murtha (V)
Fiona Yelnoorkar (F)
Jonathan Chamberlain (J)
Kim Hinshaw (K)
Judith Ormonde (J)
Kayleigh Lennox (K)
Partha Sengupta (P)
Jean Dent (J)
Fiona Campbell (F)
Krithiga Ilangovan (K)
Sadia Malick (S)
Saikat Banerjee (S)
Khaled Abaoub (K)
Kashif Burney (K)
Karen Jermy (K)
Mahalakshmi Gorti (M)
Ajay Pankhania (A)
Andrew Hatrick (A)
Shaheen Khazali (S)
Linda Bailey (L)
Claire Atkinson (C)
Martha Wrigley (M)
Michelle Davies (M)
Michael Katesmark (M)
Shree Datta (S)
Jason Cooper (J)
Amanda Redford (A)
David Wells (D)
Suzanne Jerreat (S)
Angela Rooney (A)
Gourab Misra (G)
Zeiad El-Gizawy (Z)
Bruce Jarvest (B)
Joanne Lakin (J)
Patrick Shaughn O'Brien (PS)
Douglas Tincello (D)
Ian Scudamore (I)
C J Elson (CJ)
Marwan Habiba (M)
Tanu Singhal (T)
Amman Bolia (A)
Adebimpe Matiluko (A)
Farook Al-Azzawi (F)
Michael Glasby (M)
Carla Christie (C)
Katie Warwick (K)
David Pring (D)
Olujimi Jibodu (O)
Nicola Dean (N)
Anthony Bowker (A)
Andrew Gibson (A)
Zoe Coleman (Z)
Thomas Smith (T)
Chris Rhymes (C)
Lavinia Margarit (L)
Richard Penketh (R)
Catherine Lloyd-Bennett (C)
Helen Goldring (H)
Tudor Young (T)
Gareth Tudor (G)
Martin C Powell (MC)
Nicholas Raine-Fenning (N)
Anna Molnar (A)
Gill Kirkwood (G)
Lucinda Wilson (L)
Shahnaz Akbar (S)
Preeti Patil (P)
Pauline Barrett (P)
Hany Lashen (H)
Trevor Cleveland (T)
Clare Pye (C)
Sister Sheila Duffy (SS)
Douglas Turner (D)
Steven Thomas (S)
Christopher Wragg (C)
Andrew J Baxter (AJ)
Julie Metherall (J)
Edward P Morris (EP)
Simon Girling (S)
Helene Woodhouse (H)
Paul Simpson (P)
Thilina Palihawadana (T)
John Graeme Houston (JG)
Vanessa Kay (V)
Wendy McMullen (W)
Audrey Lyall (A)
Rachael Banks (R)
Helen Cumming (H)
Pamel Duthie (P)
Richard Hutson (R)
Jaime Canbell (J)
Chris Hammond (C)
David Kessel (D)
Simon J McPherson (SJ)
Jacqueline Tay (J)
Jai Patel (J)
Sapna Puppala (S)
Jonathan Pearce (J)
Marie Home (M)
Viv Dolby (V)
Cathy Cocking (C)
Sharon Nettleton (S)
Neil Davies (N)
Eleni Mavrides (E)
Adam Magos (A)
Ioannis Tsimpanakos (I)
Mina Karamshi (M)
Doug Altman (D)
Jim Thornton (J)
Siladitya Bhattacharya (S)
Hilary Critchley (H)
Tony Nicholson (T)
Alison Hurst (A)
John Reidy (J)
Nick Amin (N)
Duncan Ettles (D)
Jim Reekers (J)
David Cooper (D)

Commentaires et corrections

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Informations de copyright

Copyright © 2020 Massachusetts Medical Society.

Auteurs

Isaac Manyonda (I)

From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.

Anna-Maria Belli (AM)

From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.

Mary-Ann Lumsden (MA)

From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.

Jonathan Moss (J)

From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.

William McKinnon (W)

From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.

Lee J Middleton (LJ)

From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.

Versha Cheed (V)

From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.
ORCID: 0000-0002-6713-0913

Olivia Wu (O)

From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.

Fusun Sirkeci (F)

From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.

Jane P Daniels (JP)

From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.
ORCID: 0000-0003-3324-6771

Klim McPherson (K)

From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Procédures de chirurgie opératoire › Procédures de chirurgie urogénitale › Procédures de chirurgie gynécologique › Hystéroscopie › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Analyse en intention de traitement › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Complications peropératoires › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Procédures de chirurgie opératoire › Interventions chirurgicales mini-invasives › Endoscopie › Laparoscopie › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Tumeurs › Tumeurs par type histologique › Tumeurs du tissu conjonctif et des tissus mous › Tumeurs du tissu musculaire › Léiomyome › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Services de santé › Soins aux patients › Hospitalisation › Durée du séjour › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Troubles de la menstruation › Ménorragie › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Réserve ovarienne › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Complications postopératoires › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Procédures de chirurgie opératoire › Réintervention › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Procédures de chirurgie opératoire › Procédures de chirurgie urogénitale › Procédures de chirurgie gynécologique › Embolisation d'artère utérine › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Procédures de chirurgie opératoire › Procédures de chirurgie urogénitale › Procédures de chirurgie gynécologique › Myomectomie de l'utérus › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Maladies urogénitales › Tumeurs de l'appareil urogénital › Tumeurs de l'appareil génital féminin › Tumeurs de l'utérus › Uterine-Artery Embolization or Myomectomy for...
questionsmedicales.fr › Appareil urogénital › Système génital › Système génital de la femme › Utérus › Uterine-Artery Embolization or Myomectomy for...