Comparison Between Transvaginal Mesh and Traditional Surgery for Pelvic Organ Prolapse
NCT ID: NCT00566917
Last Updated: 2010-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
400 participants
INTERVENTIONAL
2007-12-31
2010-01-31
Brief Summary
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Traditional surgical techniques are frequently associated with unsatisfying anatomical recurrence rates and it is plausible that inherently weak, or damaged, pelvic floor supportive tissues need to be reinforced by a permanent support to avoid the high rates of recurrences commonly described using traditional techniques. Over the years sporadic attempts have been made to introduce novel surgical techniques using a variety of biomaterials with varying success. Despite a lack of clinical safety data, or compelling clinical evidence demonstrating that it improves outcomes compared to traditional suture techniques, use of biomaterials in pelvic reconstructive surgery has become widespread in just a few years .
It is likely that biomaterials need to be "anchored" in tissues not afflicted by the disease, in order to provide the intended pelvic floor support. This has given rise to transvaginal surgical techniques using a transobturator approach passing the mesh through the arcus tendineous fascia pelvis, or the sacrospinous ligaments through a transgluteal approach. Short term data from concluded and on-going safety assessments of these techniques has provided promising results and satisfying clinical outcomes. The aim of the present study is to compare anterior mesh repair (PROLIFT®) with traditional suture repair in a randomised trial.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Anterior colporrhaphy (standardised)
Anterior colporrhaphy
Standardised colporrhaphy of the anterior vaginal wall
2
Anterior PROLIFT
Anterior PROLIFT
Transvaginal mesh surgery of the anterior vaginal wall
Interventions
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Anterior colporrhaphy
Standardised colporrhaphy of the anterior vaginal wall
Anterior PROLIFT
Transvaginal mesh surgery of the anterior vaginal wall
Eligibility Criteria
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Inclusion Criteria
* Prolapse of the anterior vaginal wall ≥POPQ-stadium II
* Prolapse specific pelvic symptom
* Being able to make an informed consent on participation
* Physically and cognitive capable of participating in the required follow-up
* No other pelvic floor surgery performed at the time of anterior repair
Exclusion Criteria
* Severe rheumatic disease
* Insulin treated diabetes mellitus
* Connective tissue disorders (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Danhlos, collagenosis, polymyositis eller rheumatic myalgia)
* Current systemic steroid treatment
18 Years
FEMALE
No
Sponsors
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The regional agreement on medical training and clinical research (ALF) between Stockholm county council and Karolinska Institutet.
UNKNOWN
The Swedish Society of Medicine
OTHER
Investigators meetings supported by Gynecare Scandinavia.
UNKNOWN
Karolinska Institutet
OTHER
Responsible Party
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Karolinska Institutet
Principal Investigators
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Daniel Altman, MD, Assoc. prof.
Role: STUDY_CHAIR
Karolinska Institutet
Christian Falconer, MD, Assoc. prof.
Role: STUDY_DIRECTOR
Karolinska Institutet at Danderyd University Hospital
Daniel Altman, MD, Assoc. prof.
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Nyköbing Hospital
Nyköbing, , Denmark
Skejby Hospital
Skejby, , Denmark
Hyvinkää Hospital
Hyvinkää, , Finland
Jorvi Hospital
Jorvi, , Finland
Central Finland Central Finland
Jyväskylä, , Finland
Central Finland Central Hospital
Kotka, , Finland
South Carelian Central Hospital
Lappeenranta, , Finland
Lohja Hospital
Lohja, , Finland
Porvoo Hospital
Porvoo, , Finland
Lapland Central Hospital
Rovaniemi, , Finland
Åbo Hospital
Turku, , Finland
Akershus University Hospital
Ahus, , Norway
Haukeland Hospital
Bergen, , Norway
Innlandet Hospital
Brumunddal, , Norway
Bærum Hospital
Bærum, , Norway
Sörlandet Hospital
Flekkefjord, , Norway
Förde Hospital
Förde, , Norway
Ringerike Hospital
Hönefoss, , Norway
Kongsberg Hospital
Kongsberg, , Norway
Levanger Hospital
Levanger, , Norway
Namsos Hospital
Namsos, , Norway
Rikshospitalet
Oslo, , Norway
Telemark Hospital
Skien, , Norway
Stavanger University Hospital
Stavanger, , Norway
The Regional Hospital in Tromsø
Tromsø, , Norway
St Olav Hospital
Trondheim, , Norway
Borås Hospital
Borås, , Sweden
Höglandssjukhuset
Eksjö, , Sweden
Sahlgrenska Hospital
Gothenburg, , Sweden
Halmstad Hospital
Halmstad, , Sweden
Huddiksvall Hospital
Huddiksvall, , Sweden
Karlskoga Hospital
Karlskoga, , Sweden
Karlskrona Hospital
Karlskrona, , Sweden
Karlstad Hospital
Karlstad, , Sweden
Kristiansstad Hospital
Kristiansstad, , Sweden
Linköping University Hospital
Linköping, , Sweden
Sunderby Hospital
Luleå, , Sweden
Vrinnevi Hospital
Norrköping, , Sweden
Capio Läkargruppen Örebro
Örebro, , Sweden
Örebro University Hospital
Örebro, , Sweden
Skaraborg Hospital Skövde
Skövde, , Sweden
Södertälje Hospital
Södertälje, , Sweden
Danderyd University Hospital
Stockholm, , Sweden
Karolinska University Hospital Huddinge
Stockholm, , Sweden
S:t Göran Hospital
Stockholm, , Sweden
South Hospital
Stockholm, , Sweden
Sundsvall Hospital
Sundsvall, , Sweden
NÄL Hospital
Trollhättan, , Sweden
Uppsala Academic Hospital
Uppsala, , Sweden
Värnamo Hospital
Värnamo, , Sweden
Västerås Hospital
Västerås, , Sweden
Västervik Hospital
Västervik, , Sweden
Ystad Hospital
Ystad, , Sweden
Countries
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References
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Yeung E, Baessler K, Christmann-Schmid C, Haya N, Chen Z, Wallace SA, Mowat A, Maher C. Transvaginal mesh or grafts or native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2024 Mar 13;3(3):CD012079. doi: 10.1002/14651858.CD012079.pub2.
Elmer C, Falconer C, Hallin A, Larsson G, Ek M, Altman D; Nordic Transvaginal Mesh Group. Risk factors for mesh complications after trocar guided transvaginal mesh kit repair of anterior vaginal wall prolapse. Neurourol Urodyn. 2012 Sep;31(7):1165-9. doi: 10.1002/nau.22231. Epub 2012 Apr 19.
Altman D, Vayrynen T, Engh ME, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med. 2011 May 12;364(19):1826-36. doi: 10.1056/NEJMoa1009521.
Other Identifiers
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TVM III-07
Identifier Type: -
Identifier Source: org_study_id