Pelvic Organ ProlapseNCT03573752
Study of Outpatient Management for Promontofixation by Laparoscopy
A study testing outpatient management for promontofixation by laparoscopy and questionnaire in people with Pelvic Organ Prolapse, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Laparoscopic promontofixation is becoming increasingly common and is currently the standard surgical procedure for pelvic prolapse, with few complications including exposure and mesh infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- outpatient management for promontofixation by laparoscopy and questionnaire
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jul 2018to 30 Dec 2021
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman with promontofixation indication by laparoscopy for prolapse cure
- Patient's desire for outpatient management
- Age ≥18 years and <70 years
- Absence of a major medical or surgical history that would prolong hospitalization (ASA 1 or 2, absence of Obstructive Sleep Apnea Syndrome)
- Subject affiliated to a social security scheme
- Subject having signed an informed consent
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- Availability of a caregiver, responsible and valid (for the first 48 hours after the potential early exit) at home
- Geographical distance less than one hour from a suitable care facility
- Access to a telephone or a means of transport if necessary
- Patient compliance
- Oral and written comprehension of pre- and post-operative instructions
- Correct housing condition
- Subject having been informed of the results of the prior medical examination
Who cannot join
- Laparoscopic contraindication
- Comorbidity needs of medical supervision most of 24h
- TVT-O procedure during the same surgery
- Mental handicap affecting autonomy
- Comprehension difficulties to understand the protocol
- No social protection
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- Subject with curatorship or guardianship
- Morbid obesity
- Alcohol or drugs addiction
- Excessive anxiety
- Impossibility to give the subject enlightened information (subject in emergency situation...)
- Pregnant woman (positive urinary pregnancy test for women of childbearing age)
Trial locations and contacts
1 site in 1 country.
France1 site
Service de gynécologie, Centre Médico Chirurgical Obstétrical, Hôpitaux Universitaires de Strasbourg
Schiltigheim, 67303
About this study
Laparoscopic promontofixation is becoming increasingly common and is currently the standard surgical procedure for pelvic prolapse, with few complications including exposure and mesh infection.
The research hypothesis is that laparoscopic promontofixation is a relatively painless procedure and can be performed on an outpatient basis without increasing the number of postoperative complications and impairing patients' quality of life.
Read more
The objective of this study is to evaluate the number of rehospitalizations after management of promontofixation by laparoscopy on an outpatient basis.
To evaluate the feasibility of a postoperative H8 exit after laparoscopic promontofixation.
Each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- outpatient management for promontofixation by laparoscopy, questionnaire
- Keywords
- Laparoscopic Promontofixation, Outpatient management
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outpatient management for promontofixation by laparoscopyOther
postoperative H8 exit after laparoscopic promontofixation
questionnaireOther
Each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of rehospitalizations occurring between outpatient discharge and postoperative follow-up consultation
Rate of rehospitalizations occurring between outpatient discharge and postoperative
Measured: 35 to 70 Days after the intervention
Secondary outcomes (8)
Exit rate at postoperative H8 according to post-anesthesia discharge scoring system score according to Chung.
This score considers six criteria: vital signs, ambulation, nausea/vomiting, pain, bleeding and voiding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a score of 9 or more are considered ready for discharge.
Measured: Hour 8 after the intervention
Quality of life assessed by the Euroqol EQ-5D index (EuroQol five dimension scale)
The EQ-5D questionnaire is made up for two components; health state description and evaluation. In description part, health status is measured in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using three-level (3L) scale; having no problems, having some or moderate problems, being unable to do/having extreme problems. The respondents are asked to choose the statement which best describes their health status of surveyed day.
In evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS). The patient is asked to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to "the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".
Measured: Day 0, 3, 7 and 30 after the intervention
Assess the satisfaction of the patients by answering a Patient Satisfaction Questionnaire
Assess the satisfaction of the patients by answering a Patient Satisfaction Questionnaire. It includes a satisfaction scale ranging from 0 to 10 and 2 closed-response questions, with the possibility of adding a free comment.
Measured: Day 30 after the intervention
Assess the postoperative anxiety by the State-Trait Anxiety Inventory (STAI) form Y-A.
Assess the postoperative anxiety by the State-Trait Anxiety Inventory (STAI) form Y-A. This form has 20 items for assessing state anxiety. All items are rated on a 4-point scale. Higher scores indicate greater anxiety.
Measured: Day 0, 1, 2, 3, 7 and 30 after the intervention
Assess postoperative pain by the Visual Analogue Scale (VAS) and the consumption of analgesics.
Assess postoperative pain by the Visual Analogue Scale (VAS) and the consumption of analgesics. This scale consists of a straight line with the endpoints defining extreme limits such as "no pain at all" and "pain as bad as it could be". The patient is asked to mark his pain level on the line between the two endpoints. The distance between "no pain at all" and the mark then defines the subject's pain.
Measured: 8 hours after surgery (Day 0)/ At 8 a.m. and 6 p.m. (Day 1, 2 and 3)/ At 8 a.m. (Day 4, 5, 6, 7 and 30)
Rates of postoperative complications
Rates of postoperative complications
Measured: 35 to 70 Days after the intervention
Number of emergency consultations before scheduled postoperative follow-up consultation
Number of emergency consultations before scheduled postoperative follow-up consultation
Measured: 35 to 70 Days after the intervention
Difference in actual costs and cost-effectiveness between conventional and outpatient care
Collection of the PMSI (medical information system program) of the made act and the cost of the hospital stay in ambulatory for a laparoscopic promontofixation.
Measured: 35 to 70 Days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start26 Jul 2018
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
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 University Hospital, Strasbourg, FranceThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573752
- Sponsor's protocol ID
- 6796
- Status last verified
- Dec 2025
- First submitted
- 5 Apr 2018
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Collin-Bund V, Viviani V, Meyer N, Goetsch T, Boisrame T, Faller E, Lecointre L, Gabriele V, Akladios C, Garbin O, Host A. Study of the feasibility of outpatient sacrocolpopexy by laparoscopy. J Gynecol Obstet Hum Reprod. 2024 Sep;53(7):102792. doi: 10.1016/j.jogoh.2024.102792. Epub 2024 Apr 23.
PubMed 38663686
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Outpatient Management for Promontofixation by Laparoscopy
- ClinicalTrials.gov ID
- NCT03573752
- Acronym / sponsor ID
- 6796
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Laparoscopic Promontofixation, Outpatient management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 29 Jun 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.
Laparoscopic promontofixation is becoming increasingly common and is currently the standard surgical procedure for pelvic prolapse, with few complications including exposure and mesh infection.
The research hypothesis is that laparoscopic promontofixation is a relatively painless procedure and can be performed on an outpatient basis without increasing the number of postoperative complications and impairing patients' quality of life.
The objective of this study is to evaluate the number of rehospitalizations after management of promontofixation by laparoscopy on an outpatient basis.
To evaluate the feasibility of a postoperative H8 exit after laparoscopic promontofixation.
Each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Woman with promontofixation indication by laparoscopy for prolapse cure
- Patient's desire for outpatient management
- Age ≥18 years and <70 years
- Absence of a major medical or surgical history that would prolong hospitalization (ASA 1 or 2, absence of Obstructive Sleep Apnea Syndrome)
- Subject affiliated to a social security scheme
Key exclusion criteria (12 listed)
- Laparoscopic contraindication
- Comorbidity needs of medical supervision most of 24h
- TVT-O procedure during the same surgery
- Mental handicap affecting autonomy
- Comprehension difficulties to understand the protocol
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 |
|---|---|---|
| outpatient management for promontofixation by laparoscopypostoperative H8 exit after laparoscopic promontofixation | Other | – |
| questionnaireEach patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction. | Other | – |
Primary outcome
Rate of rehospitalizations occurring between outpatient discharge and postoperative follow-up consultation
Time frame: 35 to 70 Days after the intervention
Rate of rehospitalizations occurring between outpatient discharge and postoperative
8 secondary outcomes
Exit rate at postoperative H8 according to post-anesthesia discharge scoring system score according to Chung.
Time frame: Hour 8 after the intervention
Quality of life assessed by the Euroqol EQ-5D index (EuroQol five dimension scale)
Time frame: Day 0, 3, 7 and 30 after the intervention
Assess the satisfaction of the patients by answering a Patient Satisfaction Questionnaire
Time frame: Day 30 after the intervention
Assess the postoperative anxiety by the State-Trait Anxiety Inventory (STAI) form Y-A.
Time frame: Day 0, 1, 2, 3, 7 and 30 after the intervention
Assess postoperative pain by the Visual Analogue Scale (VAS) and the consumption of analgesics.
Time frame: 8 hours after surgery (Day 0)/ At 8 a.m. and 6 p.m. (Day 1, 2 and 3)/ At 8 a.m. (Day 4, 5, 6, 7 and 30)
Rates of postoperative complications
Time frame: 35 to 70 Days after the intervention
Number of emergency consultations before scheduled postoperative follow-up consultation
Time frame: 35 to 70 Days after the intervention
Difference in actual costs and cost-effectiveness between conventional and outpatient care
Time frame: 35 to 70 Days after the intervention
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 19 Dec 2025.
- Results publication: PubMed 38663686Collin-Bund V, Viviani V, Meyer N, Goetsch T, Boisrame T, Faller E, Lecointre L, Gabriele V, Akladios C, Garbin O, Host A. Study of the feasibility of outpatient sacrocolpopexy by laparoscopy. J Gynecol Obstet Hum Reprod. 2024 Sep;53(7):102792. doi: 10.1016/j.jogoh.2024.102792. Epub 2024 Apr 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing outpatient management for promontofixation by laparoscopy and questionnaire in people with Pelvic Organ Prolapse, run by University Hospital, Strasbourg, France 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 13 inclusion and 12 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 19 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 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?
Rate of rehospitalizations occurring between outpatient discharge and postoperative follow-up consultation (time frame: 35 to 70 Days after the intervention). 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 NCT03573752, 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 19 Dec 2025.