CompletedNot Applicable

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

France365 participantsStarted 2011-06-22

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

presence/absence of complications (composite score)

Timeframe: 30 days

Trial details

NCT IDNCT01320215

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-25