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โ† Trials
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LAparoscopic Preventive PRErectal Mesh

RecruitingNAAges 40 Years - 75 YearsFemaleUniversity Hospital, Lille
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In plain words

What the trial is, and whether it could suit you

Urogenital prolapse is a frequent and invalidating pathology in women, involving the anterior vaginal wall and the uterus in most cases. Posterior vaginal wall prolapse is present in only 50% of cases. Surgery is an option for women with troublesome prolapse. A woman's lifetime risk of undergoing surgery for pelvic organ prolapse (POP) surgery by the age of 80 is around 19%. Laparoscopic sacrocolpopexy (LS) with synthetic non-absorbable mesh is considered the gold standard, with a composite success rate of 85% at one year (Prospere study). Based on early experience and historical habits, a prerectal mesh was used to be systematically placed in the rectovaginal space, in addition to the anterior and apical mesh placed in the vesicovaginal space, in order to prevent de-novo posterior prolapse (reported rates up to 33%). The benefit of preventive prerectal mesh is questionned on the basis

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Women with a urogenital prolapse (anterior wall and/or uterus or vaginal apex) stage = 2 (Ba and/or C points โ‰ฅ - 1 cm using the POP-Q system), * without significant posterior vaginal wall prolapse (Bp \< -1 cm when apical prolapse is reduced using a retractor leaving the posterior vaginal wall free), Exclusion Criteria: * Previous surgical repair for Pelvic Organ Prolapse * Any associated prolapse requiring any non-authorized additional surgical repair (Authorized additional surgical procedures are hysterectomy, ovariectomy, adnexectomy, salpingectomy, myomectomy, or suburethral vaginal tape.) * Wish for future pregnancy * Lack of health insurance * Woman not reading French or unable to consent * Woman under law protection
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What it tests

  • Single-Anterior-Mesh, SAM
  • Double-Mesh, DM
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Where

9 sites
Hopital Estaing
Clermont-Ferrand, France
Ch Dunkerque
Dunkirk, France
Hopital Saint-Louis - La Rochelle
La Rochelle, France
Clinique Du Pre
Le Mans, France
Hop Jeanne de Flandre Chu Lille
Lille, France
Hopital Saint Vincent - Saint Antoine
Lille, France
Chu de Nice Hopital de L'Archet
Nice, France
Chu Nimes - Nimes
Nรฎmes, France

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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