Vaginal Vault ProlapseNCT01394237
Laparoscopic Sacrocolpopexy: Long Term Follow-up
An observational study of Vaginal Vault Prolapse, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine the long term results of laparoscopic sacrocolpopexy regarding anatomical results, recurrences, complications, further surgeries required, patients satisfaction and quality of life. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Vaginal Vault Prolapse
- What is being tested?
- Examination
- How many people
- 75 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2011to Dec 2011
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated for vaginal vault prolapse at our institution by laparoscopic sacrocolpopexy between 2003 and 2007
Who may be able to join
- Patients operated for vaginal vault prolapse at our institution by laparoscopic sacrocolpopexy between 2003 and 2007
- consent
Who cannot join
- no consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Frauenklinik Kantonsspital Aarau
Aarau, Canton of Aargau, 5001
About this study
Official title: Laparoscopic Sacrocolpopexy: Long Term Results With Special Focus on Anatomical Results and Quality of Life
The purpose of this study is to determine the long term results of laparoscopic sacrocolpopexy regarding anatomical results, recurrences, complications, further surgeries required, patients satisfaction and quality of life.
- Conditions
- Vaginal Vault Prolapse
- Being tested
- Examination
- 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.
ExaminationOther
Also called exam, test, assessment
Examination of recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system
| Study group | Role | What they receive |
|---|---|---|
| Operated by laparoscopic sacrocolpopexy | Patients operated at our institution by laparoscopic sacrocolpopexy between 2003 and 2007 Receives: Other: Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrences according to pelvic organ prolapse quantification (POP-Q) assessment
Recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system
Measured: 3-6 years after surgery
Secondary outcomes (1)
Quality of life
Quality of life as assessed by a specific validated questionnaire
Measured: 3-6 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionDec 2011
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 Vaginal Vault 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitri Sarlos, Kantonsspital Aarau
- Investigators
- Dimitri Sarlos, MD, Study director, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394237
- Sponsor's protocol ID
- SakPexFup
- Status last verified
- Mar 2014
- First submitted
- 13 Jul 2011
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sarlos D, Brandner S, Kots L, Gygax N, Schaer G. Laparoscopic sacrocolpopexy for uterine and post-hysterectomy prolapse: anatomical results, quality of life and perioperative outcome-a prospective study with 101 cases. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Oct;19(10):1415-22. doi: 10.1007/s00192-008-0657-0. Epub 2008 Jun 7.
PubMed 18536861
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Sacrocolpopexy: Long Term Results With Special Focus on Anatomical Results and Quality of Life
- ClinicalTrials.gov ID
- NCT01394237
- Acronym / sponsor ID
- SakPexFup
- Conditions
- Vaginal Vault Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Jul 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 purpose of this study is to determine the long term results of laparoscopic sacrocolpopexy regarding anatomical results, recurrences, complications, further surgeries required, patients satisfaction and quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operated by laparoscopic sacrocolpopexy | – | Other: ExaminationPatients operated at our institution by laparoscopic sacrocolpopexy between 2003 and 2007 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated for vaginal vault prolapse at our institution by laparoscopic sacrocolpopexy between 2003 and 2007
Key inclusion criteria (2 listed)
- Patients operated for vaginal vault prolapse at our institution by laparoscopic sacrocolpopexy between 2003 and 2007
- consent
Key exclusion criteria (1 listed)
- no consent
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 |
|---|---|---|
| ExaminationAlso: exam, test, assessmentExamination of recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system | Other | Operated by laparoscopic sacrocolpopexy |
Primary outcome
Recurrences according to pelvic organ prolapse quantification (POP-Q) assessment
Time frame: 3-6 years after surgery
Recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system
1 secondary outcome
Quality of life
Time frame: 3-6 years after surgery
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 12 Mar 2014.
- Background: PubMed 18536861Sarlos D, Brandner S, Kots L, Gygax N, Schaer G. Laparoscopic sacrocolpopexy for uterine and post-hysterectomy prolapse: anatomical results, quality of life and perioperative outcome-a prospective study with 101 cases. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Oct;19(10):1415-22. doi: 10.1007/s00192-008-0657-0. Epub 2008 Jun 7.
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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.
Dimitri Sarlos, MD study director
Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Vault Prolapse, run by Kantonsspital Aarau at 1 site in Switzerland.
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 2 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 12 Mar 2014. 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 Switzerland. 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?
Recurrences according to pelvic organ prolapse quantification (POP-Q) assessment (time frame: 3-6 years after surgery). 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 NCT01394237, 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 12 Mar 2014.