Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
NCT ID: NCT01320215
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
365 participants
INTERVENTIONAL
2011-06-22
2022-01-25
Brief Summary
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The patient diary did not allow the collection of sufficiently precise data to meet the secondary medico-economic objective of the study. Access to data from the National Health Data System (SDNS), which was not available at the time of the initial drafting of this protocol, now makes it possible to obtain a complete picture of patients' health care consumption. We propose, therefore, to extract data from the SNIIRAM via the SNDS (matching of patients' NIR to their health care consumption) in order to retrieve and accurately estimate the cost of follow-up.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Robot arm
The patients in this arm will have a robot-assisted promontofixation.
Robot-assisted promontofixation
Sacrohysteropexy with robotic assistance (da Vinci robot)
Non-robot arm
The patients in this arm with have a promotofixation via a laparoscopy, but without robot assistance.
Non-robot assisted promontofixation
Laparoscopic sacrohysteropexy, without robot assistance
Interventions
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Robot-assisted promontofixation
Sacrohysteropexy with robotic assistance (da Vinci robot)
Non-robot assisted promontofixation
Laparoscopic sacrohysteropexy, without robot assistance
Eligibility Criteria
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Inclusion Criteria
* The patient must have given her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 60 months of follow-up
Exclusion Criteria
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* Patient has a stage-1 prolapse (POP-Q classification)
* Patient has asymptomatic prolapse
* The patient has a prolapse recurrence (i.e. this is not the first case of prolapse)
* The patient is not available for 60 months of follow-up
* Patient has a vaginal or urinary infection
* Patient has poorly-adjusted diabetes
* Patient on long-term corticotherapy
* Patient has previously had pelvic radiotherapy
* Patient has contraindication for anesthesia
* Patient has an intestinal inflammatory disease
18 Years
FEMALE
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Stéphane Droupy, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nîmes
Locations
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CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, France
Groupe Urologie Saint Augustin
Bordeaux, , France
APHP - Centre Hospitalier Henri Mondor
Créteil, , France
CHU de Dijon
Dijon, , France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, , France
CHU de Nancy - Hôpitaux de Brabois
Nancy, , France
CHU de Nantes
Nantes, , France
CHU de Nice - Hôpitaux L'Archet 1 et 2
Nice, , France
Clinique Kennedy
Nîmes, , France
Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly
Paris, , France
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, , France
CHU de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Rennes - Hôpital PontChaillou
Rennes, , France
Clinique Belledonne
Saint Martin d'Héres, , France
CHRU de Strasbourg - Hôpital Civil
Strasbourg, , France
Hôpital Foch
Suresnes, , France
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, , France
CHRU de Tours - Hôpital Bretonneau
Tours, , France
Countries
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References
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Gris JC, Chea M, Bouvier S, Pereira FR. Antiphospholipid Antibodies in Mental Disorders. Semin Thromb Hemost. 2025 Jun;51(4):448-456. doi: 10.1055/s-0044-1788696. Epub 2024 Jul 24.
Other Identifiers
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2010-A01110-39
Identifier Type: OTHER
Identifier Source: secondary_id
PHRC-N/2010/SD-01
Identifier Type: -
Identifier Source: org_study_id
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