LAparoscopic Preventive PRErectal Mesh (LAPREM)
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| ClinicalTrials.gov Identifier: NCT03766048 |
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Recruitment Status :
Recruiting
First Posted : December 5, 2018
Last Update Posted : September 14, 2020
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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 of a single retrospective study comparing 68 LS with double-mesh (anterior & posterior, DM) to 32 LS with a single anterior mesh (SAM): posterior recurrence rates were respectively 5.9 vs. 31.3% (p<0,01), and total recurrence rates 16.2 vs. 43.8% (p<0.01). However, as this difference was not significant in the subgroup of patients without associated cervicocystopexy, the authors concluded that the risk of posterior failure was only due to the cervicocystopexy itself (anti-urinary incontinence procedure which has been abandoned since).
On the other hand, a prerectal mesh increases the risk for specific complications: rectal injury (up to 3%), anal pain (up to 25%), mesh exposition (up to 2%). Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data). The rate of de-novo obstructed defecation after LS with prerectal mesh is reported up to 25%. It could be explained by the mesh itself, but also by nerve injuries during the dissection of the rectovaginal space and rectal stalks.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Urogenital Prolapse | Procedure: Single-Anterior-Mesh, SAM Procedure: Double-Mesh, DM | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 834 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Non-inferiority Randomized Double Blind Controlled Trial Comparing Results of Laparoscopic Sacrocolpopexy With or Without Preventive Prerectal Mesh in Women Operated for Urogenital Prolapse Without Significant Posterior Vaginal Wall Prolapse |
| Actual Study Start Date : | September 11, 2019 |
| Estimated Primary Completion Date : | July 2023 |
| Estimated Study Completion Date : | July 2023 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Single-Anterior-Mesh, SAM |
Procedure: Single-Anterior-Mesh, SAM
laparoscopic sacropexy is only performed with the anterior mes |
| Sham Comparator: Double-Mesh, DM |
Procedure: Double-Mesh, DM
laparoscopic sacropexy is performed using two synthetic non-absorbable meshes, both sutured to the promontory (Double-Mesh, DM): one mesh is placed in the vesicovaginal space and sutured to the uterine cervix or vaginal apex, and one mesh is placed in the rectovaginal space |
- Composite criteria of success at 2 years follow-up [ Time Frame: at 2 years after the intervention ]Composite criteria of success at 2 years follow-up: no symptom of vaginal bulge, no prolapse beyond the hymen (>0 cm), no reintervention for prolapse recurrence. Its advantage is that it considers only recurrences that are symptomatic or needing a reintervention. It is strongly linked with women satisfaction after prolapse surgery.
- Anatomical results [ Time Frame: at 2 years ]Anatomical results will be based on clinical evaluation of patients at 2 years follow-up using the POP-Q system, with a specific evaluation of posterior vaginal wall with measures of the Bp point
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| Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Women with a urogenital prolapse for whom a laparoscopic sacrocolpopexy is planned. |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women with a urogenital prolapse (anterior wall and/or uterus or vaginal apex) stage = 2 (Ba and/or C points ≥ - 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766048
| Contact: Jean-Philippe LUCOT, MD,PhD | (0)3 21 45 62 ext +33 | lucot.jean-philippe@ghicl.net |
| France | |
| Hopital Estaing | Recruiting |
| Clermont-Ferrand, France | |
| Ch Dunkerque | Recruiting |
| Dunkerque, France | |
| Hopital Saint-Louis - La Rochelle | Recruiting |
| La Rochelle, France | |
| Clinique Du Pre | Recruiting |
| Le Mans, France | |
| Hop Jeanne de Flandre Chu Lille | Recruiting |
| Lille, France, 59037 | |
| Contact 0320445962 | |
| Hopital Saint Vincent - Saint Antoine | Recruiting |
| Lille, France, 59037 | |
| Contact 0320445962 | |
| Chu de Nice Hopital de L'Archet | Recruiting |
| Nice, France | |
| Chu Nimes - Nimes | Recruiting |
| Nîmes, France | |
| Chi Poissy St Germain Site de Poissy | Recruiting |
| Poissy, France | |
| Principal Investigator: | Jean-Philippe LUCOT, MD,PhD | University Hospital, Lille |
| Responsible Party: | University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT03766048 |
| Other Study ID Numbers: |
2017_74 2018-A01487-48 ( Other Identifier: ID-RCB number, ANSM ) PHRCN-17-0226 ( Other Identifier: PHRC number, DGOS ) |
| First Posted: | December 5, 2018 Key Record Dates |
| Last Update Posted: | September 14, 2020 |
| Last Verified: | September 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Urogenital prolapse laparoscopic sacropexy mesh medico-economic study |
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Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |