NCT01320215

Brief Summary

The primary objective of this study is to compare 30-day complication rates associated with promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic technique versus a non-robot-assisted laparoscopic technique. Secondary objectives include comparing technical data, anatomical correction, prolapse recurrence, incontinence, quality of life and medico-economic data between the two techniques. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

June 22, 2011

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

December 4, 2025

Status Verified

October 1, 2023

Enrollment Period

10.6 years

First QC Date

March 21, 2011

Last Update Submit

November 26, 2025

Conditions

Pelvic Organ Prolapse

Keywords

da Vinci Robotuterine prolapsevaginal prolapsesacrohysteropexy

Outcome Measures

Primary Outcomes (1)

  • presence/absence of complications (composite score)

    The occurrence (in the per-operative phase or within 30 days post-op) of at least one of the following: 1) bleeding complications: hemoperitoneum, blood loss\> = 500 ml, transfusion; 2) infectious complications: wound infection, abscess, discitis, mesh infection; 3) any wound caused by a surgeon movement: bladder, digestive, ureteral, or vascular injuries; (4) medical complications: deep vein thrombosis, pulmonary embolism, pneumopathy; 5) trocart sites: infection, hernia; 6) conversion to a laparoscopic or open surgical technique not related to pre-existing adhesions; 7) reintervention; 8) neurological complications: neurological disorders, complications of the central neurological system, sciatica; 9) others: complete urinary retention, lower urinary tract infection, extrusion, erosion of the mesh, hospitalization in intensive care; 10) death.

    30 days

Secondary Outcomes (85)

  • Time needed to prep the operation room (min)

    1 day

  • length of hospital stay (days)

    1 month

  • Operative time (min)

    1 day

  • Anesthesia time (min)

    1 day

  • Equipment installation time (min)

    1 day

  • +80 more secondary outcomes

Study Arms (2)

Robot arm

EXPERIMENTAL

The patients in this arm will have a robot-assisted promontofixation.

Procedure: Robot-assisted promontofixation

Non-robot arm

ACTIVE COMPARATOR

The patients in this arm with have a promotofixation via a laparoscopy, but without robot assistance.

Procedure: Non-robot assisted promontofixation

Interventions

Non-robot assisted promontofixationPROCEDURE

Laparoscopic sacrohysteropexy, without robot assistance

Non-robot arm
Robot-assisted promontofixationPROCEDURE

Sacrohysteropexy with robotic assistance (da Vinci robot)

Robot arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has a first,(primo-event), symptomatic, genito-urinary prolapse of at least stage II (POP-Q classification) requiring surgery
  • 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

You may not qualify if:

  • The patient is participating in another study
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

Groupe Urologie Saint Augustin

Bordeaux, 33074, France

Location

APHP - Centre Hospitalier Henri Mondor

Créteil, 94000, France

Location

CHU de Dijon

Dijon, 21079, France

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHU de Nancy - Hôpitaux de Brabois

Nancy, France

Location

CHU de Nantes

Nantes, 44000, France

Location

CHU de Nice - Hôpitaux L'Archet 1 et 2

Nice, 06202, France

Location

Clinique Kennedy

Nîmes, 30900, France

Location

Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly

Paris, 75012, France

Location

APHP - Groupe Hospitalier Pitié-Salpetrière

Paris, 75651, France

Location

CHU de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

CHU de Rennes - Hôpital PontChaillou

Rennes, 35033, France

Location

Clinique Belledonne

Saint Martin d'Héres, 38400, France

Location

CHRU de Strasbourg - Hôpital Civil

Strasbourg, 67091, France

Location

Hôpital Foch

Suresnes, 92151, France

Location

CHRU de Toulouse - Hôpital de Rangueil

Toulouse, 31059, France

Location

CHRU de Tours - Hôpital Bretonneau

Tours, 37044, France

Location

Related Publications (1)

  • 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.

    PMID: 39047993RESULT

MeSH Terms

Conditions

Pelvic Organ ProlapseUterine Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Stéphane Droupy, MD PhD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 22, 2011

Study Start

June 22, 2011

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

December 4, 2025

Record last verified: 2023-10

Locations

FR(18)