title: Protocol for a Randomized Phase II Trial for Mesh Optimization by Autologous Plasma Coating in Prolapse Repair: IDEAL Stage 3.
abstract: Mesh-related complications especially after vaginal implantation have raised awareness lately because of severe adverse reactions and legal aspects. About 20% of patients suffer from complications after mesh insertion in the anterior vaginal wall. Autologous plasma coating of meshes prior to implantation has shown potential to improve the biocompatibility of meshes in vivo and in vitro. This innovative approach has been developed according to the IDEAL recommendations for surgical innovations. The method has still to be assessed at stage 3 accordingly.
  
  
  
  A protocol is developed for a prospective single-blinded randomized controlled phase II trial for biocompatibility optimization of anterior vaginal meshes for prolapse repair by autologous plasma coating versus non-coated meshes.
  
  
  
  The protocol aims at fulfilling the requirements for stage 3 (assessment) according to IDEAL. Eligible for inclusion are women with primary cystocele, requiring a surgical procedure, suitable for randomization, and willing to be randomized. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomization) and will also be reviewed in clinic 12 and 24 months post surgery. Primary endpoint is the assessment of mesh-related complications following the Clavien-Dindo classifications. QoL, sexual function assessment, efficacy, and validation of an already developed long-term register are considered secondary endpoints. To afford a calculated 10% reduction of postoperative complications through plasma-coated meshes vs. non-coated meshes at 1-year follow-up, a total 214 women in each arm will be necessary to achieve 80% power at a significance level of 5%.
  
  
  
  The protocol for this randomized clinical trial represents the conditions to assess the surgical innovation of plasma coating of meshes in order to improve the meshes' biocompatibility at stage 3 according to the IDEAL recommendations.
authors.affiliation: Department of Urology, Lukas Hospital Neuss, Neuss, Germany. holger.gerullis@gmx.net.|University Hospital for Urology, Klinikum Oldenburg, School of Medicine and Health Sciences, Carl von Ossietzky University, Oldenburg, Germany. holger.gerullis@gmx.net.|The IDEAL collaboration, Oxford, UK. holger.gerullis@gmx.net.
authors.forename: Holger
authors.initials: H
authors.lastname: Gerullis
authors.affiliation: Department of Urology, Lukas Hospital Neuss, Neuss, Germany.|The IDEAL collaboration, Oxford, UK.
authors.forename: Dimitri
authors.initials: D
authors.lastname: Barski
authors.affiliation: Department of Urology, Lukas Hospital Neuss, Neuss, Germany.
authors.forename: Evangelos
authors.initials: E
authors.lastname: Georgas
authors.affiliation: Department of Experimental Surgery, University of Szeged, Szeged, Hungary.
authors.forename: Mihaly
authors.initials: M
authors.lastname: Borós
authors.affiliation: International Tissue Engineering Research Association (ITERA), Antwerp, Belgium.
authors.forename: Albert
authors.initials: A
authors.lastname: Ramon
authors.affiliation: The IDEAL collaboration, Oxford, UK.|Department of Urology, HELIOS Hospital, Bad Saarow, Germany.
authors.forename: Thorsten H
authors.initials: TH
authors.lastname: Ecke
authors.affiliation: Leibniz Research Centre for Working Environment and Human Factors, IfADo, Dortmund, Germany.
authors.forename: Silvia
authors.initials: S
authors.lastname: Selinski
authors.affiliation: University Hospital for Gynecology, Klinikum Oldenburg, School of Medicine and Health Sciences, Carl von Ossietzky University, Oldenburg, Germany.
authors.forename: Dörte
authors.initials: D
authors.lastname: Luedders
authors.affiliation: Department of Urology, University of Luebeck, Luebeck, Germany.
authors.forename: Mario W
authors.initials: MW
authors.lastname: Kramer
authors.affiliation: University Hospital for Urology, Klinikum Oldenburg, School of Medicine and Health Sciences, Carl von Ossietzky University, Oldenburg, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Winter
authors.affiliation: University Hospital for Urology, Klinikum Oldenburg, School of Medicine and Health Sciences, Carl von Ossietzky University, Oldenburg, Germany.
authors.forename: Friedhelm
authors.initials: F
authors.lastname: Wawroschek
authors.affiliation: Department of Urology, Lukas Hospital Neuss, Neuss, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Otto
mesh_terms: D004867:Equipment Design; D005260:Female; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D012107:Research Design; D016037:Single-Blind Method; D013526:Surgical Mesh; D014596:Uterine Prolapse / Q000601:surgery*
keywords: Clinical trial; IDEAL recommendations; Plasma coating; Prolapse repair; Quality of life; Surgical innovation; Surgical mesh; Vaginal prolapse