Methods
Participation in the VIGI-MESH registry began after its approval by the
Comité de Protection des Personnes Ouest III (Institutional Review
Board) in February 2017 (IDRBC 2017-A000308-45), and the posting of the
study on Clinicaltrial.gov (NCT03052985). The Agence Nationale de
Sécurité du Médicament et des produits de santé (national medicines
agency) provided funding for the VIGI-MESH registry, but played no role
in data collection or analysis, assessment of the complications, or
interpretation of the results. The study had no support or involvement
by any manufacturer of mesh.
Participation was offered to all women undergoing surgery for anterior,
apical (uterine or vaginal vault) or posterior vaginal prolapse. Each
participating woman received information about the VIGI-MESH registry
and consented. Surgeons described each operation on a specific case
report form. We checked the data collection by reviewing mesh deliveries
from the hospital pharmacies and the surgical codes of eligible
surgeries recorded by each hospital’s medical data
department.9
This analysis considered three surgical groups: vaginal repair procedure
involving native tissue and no mesh (hereafter, vaginal repair),
transvaginal placement of mesh (hereafter, transvaginal mesh), and
laparoscopic sacropexy, which included colposacropexies (in cases of
previous or associated hysterectomy) or colpohysterosacropexies (when
the uterus was left in place) that placed mesh by laparoscopy. These
procedures are those most frequently used in high-resource
countries.11Haya N, Baessler K, Christmann-Schmid C, de Tayrac
R, Dietz V, Guldberg R, Mascarenhas T, Nusller E, Ballard E, Ankardal
M, Boudemaghe T, Wu JM, Maher CF. Prolapse and continence surgery in
countries of the Organization for Economic Cooperation and Development
in 2012. Am J Obstet Gynecol 2015;212:755.e1-27 The other, rarer
surgical procedures (sacropexy by laparotomy, laparoscopy without mesh,
and lateral suspensions) were not included in this analysis as they were
rare in our registry.9 The planned surgical group was
used for the intention-to-treat analysis; for example, a laparoscopic
sacropexy converted to a transvaginal mesh procedure was analysed as
laparoscopic sacropexy.