An interventional study of Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month) in LAPAROSCOPY and Sacrum; Anomaly, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-09.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
Among 56 studies in Congenital Abnormalities with a site in France — 10 open to participants now, 13 under way, none of them phase 3. Congenital Abnormalities · France.
Among the 56 studies in Congenital Abnormalities with a site in France, this one is the 28th largest by enrollment of the 32 interventional ones, is one of 3 that started in 2018, is one of 19 with no phase, and was the 29th registered.
781 studies on the registry are indexed under Congenital Abnormalities; 77 are open to participants now.
This study's enrollment of 21 is below the median of 40 across 466 interventional studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →10 of the 56 studies in Congenital Abnormalities with a site in France are open now, in 6 countries. Each count lists the studies.
Of the 60 Congenital Abnormalities studies recruiting now, 27 (45%) set no upper age limit and 27 (45%) stop at 75 or younger; 35 take children under 18; 22 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →56 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2018.
Median enrollment 102 across the 32 interventional studies, 95 across the 24 observational. Of the 37 that completed or were terminated, 0 (0%) have results posted.
9 of 56 have an industry lead sponsor. The 10 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 4 studies filed under Congenital Abnormalities — fewer than ten, so there is no comparison to draw.
2 of the studies in Congenital Abnormalities with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04591392atHeart MedicalSafety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD | 2027-03 |
| NCT06628375University Hospital, MontpellierA Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of Hypospadias - HYPOLLUT | 2027-09-30 |
Among the 56 studies in Congenital Abnormalities with a site in France, from their registry updates:
This study is conducted in order to determinate the faisability of an intraoperative ultrasound to mesure the positioning of prostheses during laparoscopic promontofixation.
Genital prolapse is a very common functional pathology that affects 30% of women. The functional impact of prolapse is highly variable and may lead patients to consider surgery. Surgery for laparoscopic genital prolapse (laparoscopy) is a common practice. The placement of prostheses on the anterior and posterior walls of the vagina is sort of "estimated", performed without any quality control . This technique is associated with a high rate of patient satisfaction (90% satisfaction), but a risk of anatomical recurrence in 20-30% of cases and a risk of reoperation for relapse in 3% of cases. It is likely that the lower the intervesico-vaginal prosthesis, the lower the risk of cystocele relapse is important.The postoperative ultrasound visualization of prostheses placed in promontofixation is possible: they appear hyperechoic. In particular, in anterior, where a prosthesis is placed between the vagina and the bladder, it is possible to verify that this prosthesis supports the entire bladder base.Thus, it may be possible to check the correct position of the prostheses intraoperatively. If studies were conducted postoperatively, to the best of our knowledge, no study has been conducted on the value of an intraoperative ultrasound control.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An ultrasound of the position of the prosthesis during surgery, under general anesthesia, is performed. A follow-up visit will be carried out 2 months (± 1 month) after the surgery as part of the usual care. An ultrasound of the position of the prosthesis is performed without anesthesia, either as part of the treatment or as part of the research. This measurement is performed without the intraoperative measurement by an independent sonographer.
Diagnostic Test: Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)
An ultrasound of the position of the prosthesis during surgery, under general anesthesia, is performed. A follow-up visit will be carried out 2 months (± 1 month) after the surgery as part of the usual care. An ultrasound of the position of the prosthesis is performed without anesthesia, either as part of the treatment or as part of the research. This measurement is performed without the intraoperative measurement by an independent sonographer.
Measure the distance (in mm) between the most distal part of the anterior prosthesis and the bladder neck.
Comparaison of intraoperative measurement to postoperative measurement
Time frame: at two months (± 1 month) of follow-up
Stage of prolapse
Evaluate the stage of prolapse on clinical examination according to the International Continence Society (ICS) of Pelvic Organ Prolapse Quantification System (POP-Q) classification (points Ba, Bp, C, D)
Time frame: until 2 months post-operative
Evaluate the symptoms with the PFDI-20 questionnaire
The Pelvic Floor Disorders Inventory (PFDI-20) score : This is a questionnaire so that patients can answer questions about certain symptoms: intestines, bladder or pelvic
Time frame: during 2 months post-operative
Evaluate patient satisfaction with the PGI-I questionnaire (1-7)
The Patient Global Impression of Improvement (PGI-I) : The patient should check the box corresponding to the current state of her uro-gynecological problems compared to what they were before treatment
Time frame: until 2 months post-operative
Evaluate the symptoms with the PFIQ-7 questionnaire
The Pelvic Floor Impact Questionnaire (PFIQ-7) : describe how much les activities, relationships, or feelings have been affected by symptoms bladder, bowel, or vaginal or conditions over.
Time frame: during 2 months post-operative
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Nov 2020, 33 months.
Of 71 non-industry interventional studies with no phase under Congenital Abnormalities, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's 33 months is below that.
Counting every sponsor, half of 76 studies reached it within 37 months; a quarter within 14 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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