Pelvic Organ ProlapseNCT03607344
Day Case Laparoscopic Sacrocolpopexy, a New Management
An observational study of Pelvic Organ Prolapse, run by Centre Hospitalier Universitaire de Nice.
Trial summary
Facing the stakes of hospital beds, this study assessed day case variant technic of laparoscopic sacrocolpopexy with or without robotic assistant. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Cohort
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Jun 2018
- Phase
- Observational
- 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 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study cohort is selected from the investigators institution. All consecutive patients undergoing ambulatory laparoscopic sacrocolpopexy performed by two experimented urologist surgeons at the investigators university hospital, with an ambulatory department, was enrolled.
Who may be able to join
- Patients with symptomatic anterior, apical and/or posterior compartment prolapse
- Patients with stage 2 or greater, according to the POP-Q classification
- Patients with a body mass index (BMI) < 30
- Patients with an American Society of Anesthesiologist (ASA) score < ou = 3.
Who cannot join
- Patient with prior history of pelvic cancer surgery and radiotherapy of the pelvis
About this study
Official title: Day-case Laparoscopic Sacrocolpopexy, a Compelling Option in Selected Patients
Facing the stakes of hospital beds, this study assessed day case variant technic of laparoscopic sacrocolpopexy with or without robotic assistant.
Read the detailed description
Pelvic organ prolapse (POP) is an increasingly common functional disorder which affects approximately 40% of female population. Of these 12% are symptomatic and suffer of physical and emotional distress. 11% will undergo a surgical procedure. Since its introduction by Lane in 1982, Sacrocolpopexy (SCP) became the surgical "gold standard" for correcting vaginal vault .
With minimal invasive approach, SCP had an mean hospitalization time of 3 to 7 days .
With rising health care cost and its inherent economic burden, safe and viable options to reduce cost must be sought.
Day case surgery has developed rapidly in the USA since the 1970s, and has spread to Europe, especially in Great Britain. But the High Authority of Health in France found a delay in its development.
In view of the evolution of surgical and anesthetic techniques, and the low complication rate of SCP, it seemed natural to imagine that this intervention could be done in an ambulatory setting.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Cohort
- Keywords
- Sacrocolpopexy, Day case surgery, Laparoscopic
- 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.
CohortProcedure or surgery
Patients undergoing ambulatory laparoscopic sacrocolpopexy
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of outpatient laparoscopic sacrocolpopexy
The success rate of outpatient sacrocolpopexy is defined by the number of patients who leaves hospital at the day of surgery
Measured: 1 month post-operative
Secondary outcomes (1)
Post-operative adverses events
Adverses events are readmission, hospitalization at another medical hospitalization, complication and if patient has consulted her primary care practitioner or in the emergency department
Measured: 1 month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Jan 2016
- Primary completion26 Jan 2016
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607344
- Sponsor's protocol ID
- URO-BASE04
- Status last verified
- Jul 2018
- First submitted
- 23 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day-case Laparoscopic Sacrocolpopexy, a Compelling Option in Selected Patients
- ClinicalTrials.gov ID
- NCT03607344
- Acronym / sponsor ID
- URO-BASE04
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Sacrocolpopexy, Day case surgery, Laparoscopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 26 Jan 2016 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 31 Jul 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.
Facing the stakes of hospital beds, this study assessed day case variant technic of laparoscopic sacrocolpopexy with or without robotic assistant.
Detailed description
Pelvic organ prolapse (POP) is an increasingly common functional disorder which affects approximately 40% of female population. Of these 12% are symptomatic and suffer of physical and emotional distress. 11% will undergo a surgical procedure. Since its introduction by Lane in 1982, Sacrocolpopexy (SCP) became the surgical "gold standard" for correcting vaginal vault .
With minimal invasive approach, SCP had an mean hospitalization time of 3 to 7 days .
With rising health care cost and its inherent economic burden, safe and viable options to reduce cost must be sought.
Day case surgery has developed rapidly in the USA since the 1970s, and has spread to Europe, especially in Great Britain. But the High Authority of Health in France found a delay in its development.
In view of the evolution of surgical and anesthetic techniques, and the low complication rate of SCP, it seemed natural to imagine that this intervention could be done in an ambulatory setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort is selected from the investigators institution. All consecutive patients undergoing ambulatory laparoscopic sacrocolpopexy performed by two experimented urologist surgeons at the investigators university hospital, with an ambulatory department, was enrolled.
Key inclusion criteria (4 listed)
- Patients with symptomatic anterior, apical and/or posterior compartment prolapse
- Patients with stage 2 or greater, according to the POP-Q classification
- Patients with a body mass index (BMI) < 30
- Patients with an American Society of Anesthesiologist (ASA) score < ou = 3.
Key exclusion criteria (1 listed)
- Patient with prior history of pelvic cancer surgery and radiotherapy of the pelvis
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 |
|---|---|---|
| CohortPatients undergoing ambulatory laparoscopic sacrocolpopexy | Procedure or surgery | – |
Primary outcome
The success rate of outpatient laparoscopic sacrocolpopexy
Time frame: 1 month post-operative
The success rate of outpatient sacrocolpopexy is defined by the number of patients who leaves hospital at the day of surgery
1 secondary outcome
Post-operative adverses events
Time frame: 1 month 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 31 Jul 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Centre Hospitalier Universitaire de Nice.
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 1 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 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The success rate of outpatient laparoscopic sacrocolpopexy (time frame: 1 month post-operative). 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 31 Jul 2018; AzTrials last refreshed its copy on 31 Oct 2026.