Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assiste… (NCT01320215) | Clinical Trial Compass
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 range
18 Years
Sex
FEMALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
presence/absence of complications (composite score)