LAPAROSCOPYSONOMESHNCT03410303
Per-operative Ultrasonographic Assessement of the Placement of the Mesh in Laparoscopic Sacral Colpo/Hysteropexy
A study testing Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month) in people with LAPAROSCOPY and Sacrum; Anomaly, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study is conducted in order to determinate the faisability of an intraoperative ultrasound to mesure the positioning of prostheses during laparoscopic promontofixation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- LAPAROSCOPY, Sacrum; Anomaly
- What is being tested?
- Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2018to 6 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women (>18 years-old)
- patient who undergo laparoscopic sacral copopexy/hysteropexy
- Affiliation to a public health insurance system
- Written and informed consent given by the patient
Who cannot join
- Pregnancy, breast-feading
- woan involved in an interventional research
- Patient under tutorship or curatorship
- Pregnancy and breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Intraoperative Ultrasound for the Positioning of Prostheses in Laparoscopic Surgery of Genital Prolapse
This study is conducted in order to determinate the faisability of an intraoperative ultrasound to mesure the positioning of prostheses during laparoscopic promontofixation.
Read the detailed description
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.
- Conditions
- LAPAROSCOPY, Sacrum; Anomaly
- Being tested
- Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative ultrasound | Other | 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. Receives: Diagnostic Test: Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at two months (± 1 month) of follow-up
Secondary outcomes (4)
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)
Measured: 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
Measured: 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
Measured: 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.
Measured: during 2 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start15 Jan 2018
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LAPAROSCOPYStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier DEFFIEUX, Principal investigator, AP-HP, Antoine Béclère Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410303
- Sponsor's protocol ID
- K160801J
- Acronym
- SONOMESH
- Status last verified
- Nov 2020
- First submitted
- 20 Dec 2017
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Ultrasound for the Positioning of Prostheses in Laparoscopic Surgery of Genital Prolapse
- ClinicalTrials.gov ID
- NCT03410303
- Acronym / sponsor ID
- SONOMESH / K160801J
- Conditions
- LAPAROSCOPY, Sacrum; Anomaly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted in order to determinate the faisability of an intraoperative ultrasound to mesure the positioning of prostheses during laparoscopic promontofixation.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative ultrasound | Other | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult women (>18 years-old)
- patient who undergo laparoscopic sacral copopexy/hysteropexy
- Affiliation to a public health insurance system
- Written and informed consent given by the patient
Key exclusion criteria (4 listed)
- Pregnancy, breast-feading
- woan involved in an interventional research
- Patient under tutorship or curatorship
- Pregnancy and breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Intraoperative ultrasound |
Primary outcome
Measure the distance (in mm) between the most distal part of the anterior prosthesis and the bladder neck.
Time frame: at two months (± 1 month) of follow-up
Comparaison of intraoperative measurement to postoperative measurement
4 secondary outcomes
Stage of prolapse
Time frame: until 2 months post-operative
Evaluate the symptoms with the PFDI-20 questionnaire
Time frame: during 2 months post-operative
Evaluate patient satisfaction with the PGI-I questionnaire (1-7)
Time frame: until 2 months post-operative
Evaluate the symptoms with the PFIQ-7 questionnaire
Time frame: during 2 months post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier DEFFIEUX principal investigator
AP-HP, Antoine Béclère Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month) in people with LAPAROSCOPY and Sacrum; Anomaly, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the distance (in mm) between the most distal part of the anterior prosthesis and the bladder neck. (time frame: at two months (± 1 month) of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.