Pelvic Organ ProlapseRoboLapsNCT01320215
Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
A study testing Robot-assisted promontofixation and Non-robot assisted promontofixation in people with Pelvic Organ Prolapse, run by Centre Hospitalier Universitaire de Nīmes at 18 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Robot-assisted promontofixation and Non-robot assisted promontofixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 18 sitesFrance
- Study dates
- 22 Jun 2011to 25 Jan 2022
- 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
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Groupe Urologie Saint Augustin
Bordeaux, 33074
APHP - Centre Hospitalier Henri Mondor
Créteil, 94000
CHU de Dijon
Dijon, 21079
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHU de Nancy - Hôpitaux de Brabois
Nancy
CHU de Nantes
Nantes, 44000
CHU de Nice - Hôpitaux L'Archet 1 et 2
Nice, 06202
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, 30029
Clinique Kennedy
Nîmes, 30900
Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly
Paris, 75012
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, 75651
CHU de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
CHU de Rennes - Hôpital PontChaillou
Rennes, 35033
Clinique Belledonne
Saint Martin d'Héres, 38400
CHRU de Strasbourg - Hôpital Civil
Strasbourg, 67091
Hôpital Foch
Suresnes, 92151
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, 31059
CHRU de Tours - Hôpital Bretonneau
Tours, 37044
About this study
Official title: Complications Associated With Promontofixation for Pelvic Organ Prolapse: a Randomized Trial Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Robot-assisted promontofixation, Non-robot assisted promontofixation
- Keywords
- da Vinci Robot, uterine prolapse, vaginal prolapse, sacrohysteropexy
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted promontofixationProcedure or surgery
Sacrohysteropexy with robotic assistance (da Vinci robot)
Non-robot assisted promontofixationProcedure or surgery
Laparoscopic sacrohysteropexy, without robot assistance
| Study group | Role | What they receive |
|---|---|---|
| Robot arm | Experimental | The patients in this arm will have a robot-assisted promontofixation. Receives: Procedure: Robot-assisted promontofixation |
| Non-robot arm | Active comparator | The patients in this arm with have a promotofixation via a laparoscopy, but without robot assistance. Receives: Procedure: Non-robot assisted promontofixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence/absence of complications (composite score)
The occurrence (in the per-operative phase or within 30 days post-op) of at least one of the following: 1) bleeding complications: hemoperitoneum, blood loss> = 500 ml, transfusion; 2) infectious complications: wound infection, abscess, discitis, mesh infection; 3) any wound caused by a surgeon movement: bladder, digestive, ureteral, or vascular injuries; (4) medical complications: deep vein thrombosis, pulmonary embolism, pneumopathy; 5) trocart sites: infection, hernia; 6) conversion to a laparoscopic or open surgical technique not related to pre-existing adhesions; 7) reintervention; 8) neurological complications: neurological disorders, complications of the central neurological system, sciatica; 9) others: complete urinary retention, lower urinary tract infection, extrusion, erosion of the mesh, hospitalization in intensive care; 10) death.
Measured: 30 days
Secondary outcomes (85)
Time needed to prep the operation room (min)
Measured: 1 day
length of hospital stay (days)
The number of days the patient stays in the hospital following promontofixation
Measured: 1 month
Operative time (min)
The time elapsed between incision and closure of the patient
Measured: 1 day
Anesthesia time (min)
The time elapsed between anethesia induction and awakening
Measured: 1 day
Equipment installation time (min)
Time elapsed between installation of trocarts and insertion of endoscopic instruments (robot arms or coelioscopic tools)
Measured: 1 day
Surgical time (min)
The time spent manipulating endoscopic intruments or console time for robotic techniques.
Measured: 1 day
Presence/absence of conversion
In the robot arm: the need to convert to laparoscopic procedure or open procedure; in the non-robot arm: the need to convert to an open procedure
Measured: Day 1
presence/absence of a re-intervention
Measured: 30 days
Presence/absence of urinary incontinence
Measured: 3 months
Presence/absence of urinary incontinence
Measured: 12 months
Presence/absence of urinary incontinence
Measured: 36 months
Presence/absence of urinary incontinence
Measured: 60 months
presence/absence of constipation
Measured: 3 months
presence/absence of constipation
Measured: 12 months
presence/absence of constipation
Measured: 36 months
presence/absence of constipation
Measured: 60 months
Presence/absence of fecal incontinence
Measured: 3 months
Presence/absence of fecal incontinence
Measured: 12 months
Presence/absence of fecal incontinence
Measured: 36 months
Presence/absence of fecal incontinence
Measured: 60 months
presence/absence of dysparunia
Measured: 3 months
presence/absence of dysparunia
Measured: 12 months
presence/absence of dysparunia
Measured: 36 months
presence/absence of dysparunia
Measured: 60 months
POP-Q score
Measured: 3 months
POP-Q score
Measured: 12 months
POP-Q score
Measured: 36 months
POP-Q score
Measured: 60 months
Urodynamic exam Q max (ml/s)
Urination rate il ml/s
Measured: 3 months
Urodynamic exam Q max (ml/s)
Urination rate il ml/s
Measured: 12 months
Urodynamic exam Q max (ml/s)
Urination rate il ml/s
Measured: 36 months
Urodynamic exam Q max (ml/s)
Urination rate il ml/s
Measured: 60 months
Urodynamic exam, volume urinated (ml)
the volume urinated in ml
Measured: 3 months
Urodynamic exam, volume urinated (ml)
the volume urinated in ml
Measured: 12 months
Urodynamic exam, volume urinated (ml)
the volume urinated in ml
Measured: 36 months
Urodynamic exam, volume urinated (ml)
the volume urinated in ml
Measured: 60 months
Urodynamic exam: post-mictionnel residu (ml)
Measured: 3 months
Urodynamic exam: post-mictionnel residu (ml)
Measured: 12 months
Urodynamic exam: post-mictionnel residu (ml)
Measured: 36 months
Urodynamic exam: post-mictionnel residu (ml)
Measured: 60 months
Urodynamic exam: fonctional bladder capacity (ml)
bladder capacity in ml
Measured: 3 months
Urodynamic exam: fonctional bladder capacity (ml)
bladder capacity in ml
Measured: 12 months
Urodynamic exam: fonctional bladder capacity (ml)
bladder capacity in ml
Measured: 36 months
Urodynamic exam: fonctional bladder capacity (ml)
bladder capacity in ml
Measured: 60 months
Urodynamic exam: urethral closure pressure (cm water)
urethral closure pressure in cm of water
Measured: 3 months
Urodynamic exam: urethral closure pressure (cm water)
urethral closure pressure in cm of water
Measured: 12 months
Urodynamic exam: urethral closure pressure (cm water)
urethral closure pressure in cm of water
Measured: 36 months
Urodynamic exam: urethral closure pressure (cm water)
urethral closure pressure in cm of water
Measured: 60 months
Wexner anal incontinence score
Measured: 3 months
Wexner anal incontinence score
Measured: 12 months
Wexner anal incontinence score
Measured: 36 months
Wexner anal incontinence score
Measured: 60 months
ODS constipation score
Measured: 3 months
ODS constipation score
Measured: 12 months
ODS constipation score
Measured: 36 months
ODS constipation score
Measured: 60 months
Visual analog scale for pain
Measured: day 1
Visual analog scale for pain
Measured: day 2
Visual analog scale for pain
Measured: day 3
Visual analog scale for pain
Measured: day 4
Visual analog scale for pain
Measured: 3 months
Visual analog scale for pain
Measured: 12 months
Visual analog scale for pain
Measured: 36 months
Visual analog scale for pain
Measured: 60 months
Patient satisfaction
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Measured: Day 4
Patient satisfaction
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Measured: 3 months
Patient satisfaction
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Measured: 12 months
Patient satisfaction
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Measured: 36 months
Patient satisfaction
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Measured: 60 months
Questionnaire PFDI-20
Measured: 3 months
Questionnaire PFDI-20
Measured: 12 months
Questionnaire PFDI-20
Measured: 36 months
Questionnaire PFDI-20
Measured: 60 months
Questionnaire PFIQ-7
Measured: 3 months
Questionnaire PFIQ-7
Measured: 12 months
Questionnaire PFIQ-7
Measured: 36 months
Questionnaire PFIQ-7
Measured: 60 months
Questionnaire PISQ-12
Measured: 3 months
Questionnaire PISQ-12
Measured: 12 months
Questionnaire PISQ-12
Measured: 36 months
Questionnaire PISQ-12
Measured: 60 months
Questionnaire SF36
Measured: 3 months
Questionnaire SF36
Measured: 12 months
Questionnaire SF36
Measured: 36 months
Questionnaire SF36
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study start22 Jun 2011
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Droupy, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320215
- Sponsor's protocol ID
- PHRC-N/2010/SD-01
- Other IDs
- 2010-A01110-39
- Acronym
- RoboLaps
- Status last verified
- Oct 2023
- First submitted
- 21 Mar 2011
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gris JC, Chea M, Bouvier S, Pereira FR. Antiphospholipid Antibodies in Mental Disorders. Semin Thromb Hemost. 2025 Jun;51(4):448-456. doi: 10.1055/s-0044-1788696. Epub 2024 Jul 24.
PubMed 39047993
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications Associated With Promontofixation for Pelvic Organ Prolapse: a Randomized Trial Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
- ClinicalTrials.gov ID
- NCT01320215
- Acronym / sponsor ID
- RoboLaps / PHRC-N/2010/SD-01
- Conditions
- Pelvic Organ Prolapse
- Keywords
- da Vinci Robot, uterine prolapse, vaginal prolapse, sacrohysteropexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 22 Jun 2011 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 22 Mar 2011 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot arm | Experimental | Procedure: Robot-assisted promontofixationThe patients in this arm will have a robot-assisted promontofixation. |
| Non-robot arm | Active comparator | Procedure: Non-robot assisted promontofixationThe patients in this arm with have a promotofixation via a laparoscopy, but without robot assistance. |
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)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Robot-assisted promontofixationSacrohysteropexy with robotic assistance (da Vinci robot) | Procedure or surgery | Robot arm |
| Non-robot assisted promontofixationLaparoscopic sacrohysteropexy, without robot assistance | Procedure or surgery | Non-robot arm |
Primary outcome
presence/absence of complications (composite score)
Time frame: 30 days
The occurrence (in the per-operative phase or within 30 days post-op) of at least one of the following: 1) bleeding complications: hemoperitoneum, blood loss> = 500 ml, transfusion; 2) infectious complications: wound infection, abscess, discitis, mesh infection; 3) any wound caused by a surgeon movement: bladder, digestive, ureteral, or vascular injuries; (4) medical complications: deep vein thrombosis, pulmonary embolism, pneumopathy; 5) trocart sites: infection, hernia; 6) conversion to a laparoscopic or open surgical technique not related to pre-existing adhesions; 7) reintervention; 8) neurological complications: neurological disorders, complications of the central neurological system, sciatica; 9) others: complete urinary retention, lower urinary tract infection, extrusion, erosion of the mesh, hospitalization in intensive care; 10) death.
85 secondary outcomes
Time needed to prep the operation room (min)
Time frame: 1 day
length of hospital stay (days)
Time frame: 1 month
Operative time (min)
Time frame: 1 day
Anesthesia time (min)
Time frame: 1 day
Equipment installation time (min)
Time frame: 1 day
Surgical time (min)
Time frame: 1 day
Presence/absence of conversion
Time frame: Day 1
presence/absence of a re-intervention
Time frame: 30 days
Presence/absence of urinary incontinence
Time frame: 3 months
Presence/absence of urinary incontinence
Time frame: 12 months
Presence/absence of urinary incontinence
Time frame: 36 months
Presence/absence of urinary incontinence
Time frame: 60 months
presence/absence of constipation
Time frame: 3 months
presence/absence of constipation
Time frame: 12 months
presence/absence of constipation
Time frame: 36 months
presence/absence of constipation
Time frame: 60 months
Presence/absence of fecal incontinence
Time frame: 3 months
Presence/absence of fecal incontinence
Time frame: 12 months
Presence/absence of fecal incontinence
Time frame: 36 months
Presence/absence of fecal incontinence
Time frame: 60 months
presence/absence of dysparunia
Time frame: 3 months
presence/absence of dysparunia
Time frame: 12 months
presence/absence of dysparunia
Time frame: 36 months
presence/absence of dysparunia
Time frame: 60 months
POP-Q score
Time frame: 3 months
POP-Q score
Time frame: 12 months
POP-Q score
Time frame: 36 months
POP-Q score
Time frame: 60 months
Urodynamic exam Q max (ml/s)
Time frame: 3 months
Urodynamic exam Q max (ml/s)
Time frame: 12 months
Urodynamic exam Q max (ml/s)
Time frame: 36 months
Urodynamic exam Q max (ml/s)
Time frame: 60 months
Urodynamic exam, volume urinated (ml)
Time frame: 3 months
Urodynamic exam, volume urinated (ml)
Time frame: 12 months
Urodynamic exam, volume urinated (ml)
Time frame: 36 months
Urodynamic exam, volume urinated (ml)
Time frame: 60 months
Urodynamic exam: post-mictionnel residu (ml)
Time frame: 3 months
Urodynamic exam: post-mictionnel residu (ml)
Time frame: 12 months
Urodynamic exam: post-mictionnel residu (ml)
Time frame: 36 months
Urodynamic exam: post-mictionnel residu (ml)
Time frame: 60 months
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 4 Dec 2025.
- Results publication: PubMed 39047993Gris JC, Chea M, Bouvier S, Pereira FR. Antiphospholipid Antibodies in Mental Disorders. Semin Thromb Hemost. 2025 Jun;51(4):448-456. doi: 10.1055/s-0044-1788696. Epub 2024 Jul 24.
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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.
Stéphane Droupy, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted promontofixation and Non-robot assisted promontofixation in people with Pelvic Organ Prolapse, run by Centre Hospitalier Universitaire de Nīmes at 18 sites 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 15 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 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
presence/absence of complications (composite score) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01320215, which also lists 1 linked publication.
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 4 Dec 2025.