Holger Gerullis1,2,3, Dimitri Barski4,5, Evangelos Georgas4, Mihaly Borós6, Albert Ramon7, Thorsten H Ecke5,8, Silvia Selinski9, Dörte Luedders10, Mario W Kramer11, Alexander Winter12, Friedhelm Wawroschek12, Thomas Otto4. 1. Department of Urology, Lukas Hospital Neuss, Neuss, Germany. holger.gerullis@gmx.net. 2. University Hospital for Urology, Klinikum Oldenburg, School of Medicine and Health Sciences, Carl von Ossietzky University, Oldenburg, Germany. holger.gerullis@gmx.net. 3. The IDEAL collaboration, Oxford, UK. holger.gerullis@gmx.net. 4. Department of Urology, Lukas Hospital Neuss, Neuss, Germany. 5. The IDEAL collaboration, Oxford, UK. 6. Department of Experimental Surgery, University of Szeged, Szeged, Hungary. 7. International Tissue Engineering Research Association (ITERA), Antwerp, Belgium. 8. Department of Urology, HELIOS Hospital, Bad Saarow, Germany. 9. Leibniz Research Centre for Working Environment and Human Factors, IfADo, Dortmund, Germany. 10. University Hospital for Gynecology, Klinikum Oldenburg, School of Medicine and Health Sciences, Carl von Ossietzky University, Oldenburg, Germany. 11. Department of Urology, University of Luebeck, Luebeck, Germany. 12. University Hospital for Urology, Klinikum Oldenburg, School of Medicine and Health Sciences, Carl von Ossietzky University, Oldenburg, Germany.
Abstract
INTRODUCTION: 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. METHODS: 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. RESULTS: 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%. CONCLUSION: 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.
RCT Entities:
INTRODUCTION: 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. METHODS: 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. RESULTS: 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%. CONCLUSION: 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.