Étude randomisée comparant la promontofixation cœlioscopique à la chirurgie prothétique par voie vaginale pour le traitement des cystocèles : PROSPERE (PROSthetic PElvic organ prolapse REpair)

Lucot, J P; Fritel, Xavier; Debodinance, P.; Bader, G.; Cosson, Michel; Giraudet, Géraldine; Collinet, Pierre; Rubod, Chrystèle; Fernandez, H.; Fournet, S.; Lesavre, M.; Deffieux, X.; Faivre, E.; Trichot, C.; Demoulin, G.; Jacquetin, B.; Savary, D.; Botchorichvili, R.; Loiseau, S. Campagne; Salet-Lizee, D.; Villet, R.; Gadonneix, P.; Delporte, P.; Ferry, P.; Aucouturier, J S; Thirouard, Y; Tayrac, Renaud de; Fatton, B.; Wagner, L.; Nadeau, C.; Wattiez, Arnaud; Garbin, O.; Akladios, Chérif; Thoma, V.; Thaveau, E Baulon; Saussine, C.; Hermieu, Jean-François; Delmas, V.; Blanc, Sébastien; Tardif, D; Fauconnier, Arnaud

doi:10.1016/j.jgyn.2013.03.012

Cited by 22 publications

(3 citation statements)

References 42 publications

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“…Cystocele is commonly treated by transvaginal repair with native tissue repair [ 5 ]. Sacrocolpopexy using synthetic mesh by laparoscopy is considered the surgical gold standard, but this procedure has several contraindications: baseline risk factors for mesh erosion (obesity, smoking, association with hysterectomy) and history of abdominal surgery [ 7 ]. The use of the vaginal surgery, considered as minimally invasive one, may be used in first intention for any patient suffering from symptomatic anterior POP [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial

Lacorre

Vidal

Campagne-Loiseau

et al. 2020

Trials

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Background: Native tissue cystocele repair has been the cornerstone of prolapse surgery, especially since the learned societies warned clinicians and patients about serious mesh-related complications. Surgical techniques mainly consist in anterior colporraphy and vaginal patch plastron. However, success rates of native tissue cystocele repair are heterogeneous, depending on the design of studies and definition of outcomes. To date, high-quality data comparing vaginal native tissue procedures are still lacking. Methods: Herein we aimed to describe the design of the first randomized controlled trial (TAPP) comparing anterior colporraphy (plication of the muscularis and adventitial layers of the vaginal wall) and vaginal patch plastron (bladder support anchored on the tendinous arch of the pelvic fascia by lateral sutures) techniques. Our aim is to assess the effectiveness of vaginal native tissue repair at 1 year for cystocele with a combined definition of success-anatomic and functional. The primary endpoint will be the success rate 1 year after surgery with a composite of objective and subjective measures (Aa and Ba points < 0 from POP-Q (Pelvic Organ Prolapse Quantification System) and a negative answer to question 3 of Pelvic Floor Distress Inventory and no need for additional treatment).

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Section: Introductionmentioning

confidence: 99%

Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial

Lacorre

Vidal

Campagne-Loiseau

et al. 2020

Trials

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“…Before this, the use of synthetic material in vaginal POP surgery had already dramatically decreased . In countries like France, with strong traditions of vaginal surgical techniques, mesh kits are still used with comparably low complication rates and acceptable outcome and patient satisfaction . It is not clear why in most women some of these vaginal mesh kits do not cause any problems whereas in others it leads to severe complications which can lead to the mesh needing to be removed.…”

Section: Introductionmentioning

confidence: 99%

Abnormal vaginal microbiome associated with vaginal mesh complications

Veit‐Rubin

Tayrac²,

Cartwright

et al. 2019

Neurourology and Urodynamics

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AimsTo identify differences in the vaginal microbiomes of women after transvaginal mesh (TVM) surgery for pelvic organ prolapse with and without mesh‐associated complications.MethodsPatients with complications were eligible as cases, patients without as controls. DNA was isolated and the V1‐2 region of the 16S ribosomal RNA gene was amplified and sequenced. Overall richness was quantified using Chao1. Overall diversity was expressed as Shannon diversity and screened for group differences using analysis of variance. Multivariate differences among groups were evaluated with functions from R.ResultsWe recruited 14 patients after mesh exposure, 5 after contraction, and 21 as controls. The average number of operational taxonomic unit was 74.79 (SD ± 63.91) for controls, 57.13 (SD ± 58.74) after exposures, and 92.42 (SD ± 50.01) after contractions. Total 89.6% of bacteria in controls, 86.4% in previous exposures, and 81.3% in contractions were classified as either Firmicutes, Proteobacteria, or Actinobacteria (P < .001). Veillonella spp. was more abundant in patients after contraction (P = .045). The individual microbiomes varied, and we did not detect any significant differences in richness but a trend towards higher diversity with complications.ConclusionsThe presence of Veillonella spp. could be associated with mesh contraction. Our study did not identify vaginal microbiotic dysbiosis as a factor associated with exposure. Larger cohort studies would be needed to distinguish the vaginal microbiome of women predisposed to mesh‐related complications for targeted phenotyping of patients who could benefit from TVM surgery.

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“…Most of these studies compare laparoscopic sacropexy to other vaginal or abdominal reconstructive procedures for the treatment of POP [10,11].…”

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confidence: 99%

Safety and perioperative morbidity of laparoscopic sacropexy: a systematic analysis and a comparison with laparoscopic hysterectomy

Joukhadar

Baum

Radosa

et al. 2016

Arch Gynecol Obstet

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Étude randomisée comparant la promontofixation cœlioscopique à la chirurgie prothétique par voie vaginale pour le traitement des cystocèles : PROSPERE (PROSthetic PElvic organ prolapse REpair)

Cited by 22 publications

References 42 publications

Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial

Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial

Abnormal vaginal microbiome associated with vaginal mesh complications

Safety and perioperative morbidity of laparoscopic sacropexy: a systematic analysis and a comparison with laparoscopic hysterectomy

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