Belgian Registry Vaginal Mesh

Female genital prolapse is characterized by a portion of the vaginal canal protruding (prolapsing) the opening of the vagina. This can be treated by placing vaginal mesh devices via either the abdominal or vaginal way. The standard procedure is via the abdominal canal as this is generally associated with less side effects.

However, in specific conditions (anterior or apical prolapse), the vaginal procedure can be less risky than the abdominal procedure and should therefore be preferred.

The commission de remboursement des implants et des dispositifs medicaux invasifs (CRIDMI) of the RIZIV-INAMI recently decided to reimburse transvaginal mesh devices under the conditions mentioned in annex 2.

Registration of additional information via healthdata is part of the reimbursement conditions. 3 years after the start of the reimbursement, the implanting and rehabilitation centres will have to draft a report to the CRIDMI based on the registered data.

Data and Resources

Field	Value
Modified	2020-08-05
Release Date	2018-05-04
Identifier	0583de5d-5999-4d77-bb68-3a5a0fb399d9
License	Creative Commons Attribution
Public Access Level	Public

Protocol

Protocol
Full title of the project	Belgian Registry Vaginal Mesh
Title of the project for lay people, in easily understood, i.e. non-technical, language	Belgian Registry Vaginal Mesh
Name or abbreviated title of the project where available	Prolapse
Source type	Administrative sources Patient registries

Sponsor(s)

Primary organization that oversees implementation of study and is responsible for data analysis.
Name of organisation	National Institute for Health and Disability Insurance

Commissioner(s)

Organisation that commissioned this project
Name of organisation	National Institute for Health and Disability Insurance
Website(s) of organisation	Website

Source(s) of Monetary or Material Support

Organisation providing support
Name of organisation	National Institute for Health and Disability Insurance
Website(s) of organisation	Website

Governance

Governance
Is there a Steering / Accompanying committee?	No information available

General information

General information
Project description	Female genital prolapse is characterized by a portion of the vaginal canal protruding (prolapsing) the opening of the vagina. This can be treated by placing vaginal mesh devices via either the abdominal or vaginal way. The standard procedure is via the abdominal canal as this is generally associated with less side effects. However, in specific conditions (anterior or apical prolapse), the vaginal procedure can be less risky than the abdominal procedure and should therefore be preferred. The commission de remboursement des implants et des dispositifs medicaux invasifs (CRIDMI) of the RIZIV-INAMI recently decided to reimburse transvaginal mesh devices under the conditions mentioned in annex 2. Registration of additional information via healthdata is part of the reimbursement conditions. 3 years after the start of the reimbursement, the implanting and rehabilitation centres will have to draft a report to the CRIDMI based on the registered data.
Links	Overview of Data collection for Register Prolapse

Therapeutic area
Disease	Female diseases of the urinary and reproductive systems and pregancy complications

Objective of the project
Main objective of the project	To assess the success rate and the erosion rate of the vaginal meshes.
Additional information	No additional information available

Scope
Scope	Safety Therapy

Legal basis

Type of legal basis
Type of legal basis	Unknown

Design of the project

Principal inclusion and exclusion criteria
Principal inclusion criteria	Patients who comply to the inclusion criteria as determined in CRIDMI note n° 2016/323 – see annex 2: The patient is not undergoing a concomitant hysterectomy a) anterior or apical prolapse after failure of the primary surgery. The residual prolapse is stadium 3 or stadium 2 with functional symptoms. OR b) anterior or apical prolapse stadium 3, with a high risk on recurrence or inoperability via abdominal procedures The mesh should be made of polypropylene type 1 (macroporous monofilament) according to the Amid classification. The number of patients that are eligible for reimbursement is estimated at 200-250 per year.

Data transfer frequency
Data transfer frequency	Ad hoc (event based) Unknown

Method of data transfer
Data transfer method(s)	eHealthbox of eHealth Platform

Sites involved in the project

Type of site(s)
Care Provider	General hospitals University hospitals

Health professionals involved (encoding) in the project

Health professionals involved (encoding) in the project
Care Giver	Physicians
Specialty of physicians involved (encoding) in the project	Gynaecology and obstetrics Unknown
Type of paramedical professionals involved (encoding) in the project	Unknown

Informed consent

Informed consent
Are subjects informed?	No information available
How are subjects informed?	No information available
Do subjects have to give their consent?	No information available
How do subjects give their consent?	No information available
Is there a procedure to provide subjects the ability to consult their registered information?	No information available
Is there a procedure to provide subjects the ability to correct their registered information?	No information available
Additional information	No additional information available

Review

Ethics Committee
Authorization by an Ethics Committee?	Not applicable

Sectoral Committee National Registry (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	No

Sectoral Committee Health / Social affairs (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	Yes
Full name committee	Sectoraal Comité van de Sociale Zekerheid en van de Gezondheid
Date of decision	2017-05-16
Title decision	BERAADSLAGING NR. 17/042 VAN 16 MEI 2017 BETREFFENDE DE MEDEDELING VAN GECODEERDE PERSOONSGEGEVENS DIE DE GEZONDHEID BETREFFEN DOOR ZORGVERLENERS VIA HET HEALTHDATA-PLATFORM IN HET KADER VAN HET PROJECT PROLAPS
Nr. Decision	SCSZG/17/087

Sectoral Committee Crossroads Bank of Enterprises (Privacy Commission)
Authorization by the sectorial committee Crossroads Bank of Enterprises of the Privacy Commission (Y/N)	Not applicable

Data dictionary

Classifications and Terminology
Name	Unknown

Data quality

Data quality
First year for which data is available	No information available
Procedures for checking and validating the source data	Validation levels are incorporated in the data collection process: Validation rules: validation rules are the set of predefined and functional definitions that are defined by the responsible researcher of organization. Every new registration entered in the application needs to comply to these validation rules before they can be transferred. Revision: a revision of the data is done by the responsible researcher after receiving the data to exclude any anomaly that was not detected by the validation rules.
Data compilation process	No information available
Punctuality for the most recent completed data collection: the data collection was completed	No information available
Participation rate of the health institutions	No information available
Participation rate of the health professionals	No information available
Extent of unit non-response	No information available
Extent of the item non-response	The rate of item non-response is not known or unacceptably high (>50%)
Extend to which the collected data are comparable across the Belgian regions	Comparability across the Belgian areas is unknown
Comparable or reconcilable over time	Comparability over time is unknown
Additional information	No additional information available
Extent of problems with the misclassification of statistical units for their key variables	No information available
Can records belonging to same entity be matched?	No information available
Additional information	No additional information available

Data storage

Data storage
The organisation in charge of storage of the collected data, is certified as being compliant with the international standards on information security management system (eg. ISO27001)?	No
Additional information	No additional information available

Data access

Data access
Written Data sharing policy?	No information available

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