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Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures

NCT01320215 · Centre Hospitalier Universitaire de Nīmes · Updated 4 Dec 2025

What is being tested
Robot-assisted promontofixation; Non-robot assisted promontofixation
For
Pelvic Organ Prolapse
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 365 people. The full rules are on the registry page.
Where
France (18 sites)
When
Starts or started 22 June 2011, ends 25 Jan 2022. Registered 22 March 2011.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT01320215

Sites

  • CHU de Nîmes - Hôpital Universitaire CarémeauNîmes, Gard, France
  • Groupe Urologie Saint AugustinBordeaux, France
  • APHP - Centre Hospitalier Henri MondorCréteil, France
  • CHU de DijonDijon, France
  • CHU de Montpellier - Hôpital LapeyronieMontpellier, France
  • CHU de Nancy - Hôpitaux de BraboisNancy, France
  • CHU de NantesNantes, France
  • CHU de Nice - Hôpitaux L'Archet 1 et 2Nice, France
  • Clinique KennedyNîmes, France
  • Groupe Hospitalier Diaconesses Croix Saint-Simon - Site ReuillyParis, France
  • APHP - Groupe Hospitalier Pitié-SalpetrièreParis, France
  • CHU de Lyon - Centre Hospitalier Lyon SudPierre-Bénite, France
  • CHU de Rennes - Hôpital PontChaillouRennes, France
  • Clinique BelledonneSaint Martin d'Héres, France
  • CHRU de Strasbourg - Hôpital CivilStrasbourg, France
  • Hôpital FochSuresnes, France
  • CHRU de Toulouse - Hôpital de RangueilToulouse, France
  • CHRU de Tours - Hôpital BretonneauTours, France