Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).
Adult
Coitus
Female
Follow-Up Studies
Gynecologic Surgical Procedures
/ instrumentation
Humans
Middle Aged
Patient Satisfaction
/ statistics & numerical data
Pelvic Organ Prolapse
/ physiopathology
Quality of Life
Reoperation
/ statistics & numerical data
Surgical Mesh
Treatment Outcome
Urinary Incontinence
/ physiopathology
Uterine Prolapse
/ physiopathology
Pelvic organ prolapse
randomised controlled trial
repeat surgery
synthetic mesh
Journal
BJOG : an international journal of obstetrics and gynaecology
ISSN: 1471-0528
Titre abrégé: BJOG
Pays: England
ID NLM: 100935741
Informations de publication
Date de publication:
07 2020
07 2020
Historique:
accepted:
25
02
2020
pubmed:
7
3
2020
medline:
1
7
2020
entrez:
7
3
2020
Statut:
ppublish
Résumé
To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits. Randomised controlled trial. Thirty-three UK hospitals. Women having surgery for recurrent prolapse. Women recruited using remote randomisation. Prolapse symptoms, condition-specific quality-of-life and serious adverse effects. A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision. We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis. There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.
Identifiants
pubmed: 32141709
doi: 10.1111/1471-0528.16197
doi:
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1002-1013Subventions
Organisme : Department of Health
ID : 07/60/18
Pays : United Kingdom
Organisme : Chief Scientist Office
ID : HERU1
Pays : United Kingdom
Organisme : Chief Scientist Office
ID : HSRU1
Pays : United Kingdom
Organisme : National Institute for Health Research Health Technology Assessment Programme
ID : 07/60/18
Pays : International
Investigateurs
Christine Hemming/Bain
(C)
Kevin Cooper
(K)
Peter Terry
(P)
Mohamed Abdel Fattah
(MA)
Lynn Swan
(L)
Christine Dallas
(C)
Angela Allan
(A)
Christina Henderson
(C)
Wael Agur
(W)
David Rae
(D)
Margo Henry
(M)
Danielle Gilmour
(D)
Khalid Farag
(K)
Meenakshi Dass
(M)
Michelle Reid
(M)
Philip Toozs-Hobson
(P)
Claire Burton
(C)
Pallavi Latthe
(P)
Matthew Parsons
(M)
Paula Trinham
(P)
Anna Zhao
(A)
Abimbola Williams
(A)
Philip Chia
(P)
Nadia Ali-Ross
(N)
Katrina Rhead
(K)
Raksha Mistry
(R)
Carmel Ramage
(C)
Sue Calvert
(S)
Anne Bowyer
(A)
Philip Smith
(P)
Jenny Cloete
(J)
Leigh Morrison
(L)
Heather Wilcox
(H)
Sharif Ismail
(S)
Mofid Ibraheim
(M)
Lorraine Dinardo
(L)
Denise Archer
(D)
Nichola Kearsley
(N)
Janet Spriggs
(J)
Hollie Devlin
(H)
Mohamed Matar
(M)
Claire Hagon
(C)
Toni Wilson
(T)
Jay Dasgupta
(J)
Victor Chilaka
(V)
Jill Smith
(J)
Adrian Barnett
(A)
Tracy Jackson
(T)
Rachael Worton
(R)
Caroline Bennett
(C)
Yi Ling Chan
(YL)
A Bondili
(A)
Judith Kitchingman
(J)
Jagdish Gandhi
(J)
Helen Bexhell
(H)
Vik Khullar
(V)
Ruwan Fernando
(R)
Alex Digesu
(A)
Jenny Underwood
(J)
Anand Singh
(A)
Douglas Tincello
(D)
Victoria Fowler
(V)
Carla Christie
(C)
Katie Warwick
(K)
Abdalla Fayyad
(A)
Victoria Bastion
(V)
Rose Ann Chin
(RA)
Anthony Smith
(A)
Fiona Reid
(F)
Karen Ward
(K)
Karen Rose
(K)
David Iles
(D)
Lucy Dwyer
(L)
Linda Green
(L)
Rachel Biancardi
(R)
Wilfred Kumakech
(W)
Stephanie Bateman
(S)
Rowan Connell
(R)
Susan Lord
(S)
Sharon Jones
(S)
Tracey Nolan
(T)
Rebecca Casey
(R)
Kathryn Fishwick
(K)
Tracey Lowry
(T)
Jackie Ward
(J)
Sarah Buckley
(S)
Claire Townend
(C)
Seumas Eckford
(S)
Osama Eskander
(O)
Geraldine Belcher
(G)
Amanda Skinner
(A)
Lucia Stancombe
(L)
Deborah Passmore
(D)
Richard Parkinson
(R)
Paul Hooper
(P)
Mausumi Das
(M)
Rosario Hannigan
(R)
Andy Jarvis
(A)
Emma Hickman
(E)
Delia Bester
(D)
Sarah Heawood
(S)
Robert Freeman
(R)
Luigi Bombieri
(L)
Paula Brockman
(P)
Angela King
(A)
Beverley Cree
(B)
Heidi Hollands
(H)
Patrick Hogston
(P)
Richard Parkinson
(R)
Denise Wright
(D)
Elinor Jenkins
(E)
Sanjeev Prashar
(S)
Pauline MacDonald
(P)
Julie Butler
(J)
Sue Flintoff
(S)
Daksha Patel
(D)
Janet Field
(J)
Rachel Walker
(R)
Mishell Cunningham
(M)
Sally Anne Pearson
(SA)
Meredyth Harris
(M)
Myles Taylor
(M)
Rachel Sturley
(R)
Karen Brown
(K)
Sarah Irvine
(S)
Julia Halpin
(J)
Alison Potter
(A)
Caroline Renton
(C)
Paul Ballard
(P)
Aethele Khunda
(A)
Colette Anderson
(C)
Julie Potts
(J)
Jonathan Chamberlain
(J)
Denise Milford
(D)
Eileen Walton
(E)
Subramanian Narayanan
(S)
Andrew Hall
(A)
Pauline Mercer
(P)
Barbara Finson
(B)
Fabian Imoh-Ita
(F)
Manal Reyad
(M)
Mehari Teklay
(M)
Christine Adamson
(C)
Sarah Hussain
(S)
Shankar Visvanathan
(S)
Bashir Dawlatly
(B)
Zandile Maseko
(Z)
Ayman El Naqa
(A)
Charles Cox
(C)
Khaled Afifi
(K)
Sharon Kempson
(S)
Nick Denyer
(N)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.
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