Vault Prolapse, VaginalNCT04378400
An Institutional Audit of the Short Term Complications and Long Term Outcomes of Patients Undergoing Laparoscopic Sacrocolpopexy for Vault/cervical Prolapse.
An observational study of Vault Prolapse, Vaginal, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
An institutional audit of the short term complications and long term outcomes of patients undergoing laparoscopic sacrocolpopexy for vault/cervical prolapse. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vault Prolapse, Vaginal
- What is being tested?
- Sacrocolpopexy
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Sep 2020to Dec 2025
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Since our last audit (April 30, 2014), we have operated on more than probably another 250 patients, who will be contacted. Based on our previous experience, we expect a 85% response rate.
Who may be able to join
- To be eligible, female subjects must meet the following inclusion criteria:
- Having undergone laparoscopic sacrocolpoexy at our unit.
- Agreeing to participate in the study, including completion of study-related procedures, evaluations and questionnaires, and giving informed consent.
- Follow up period of at least 6 months since the operation.
Who cannot join
- None apart from not meeting the above criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
An institutional audit of the short term complications and long term outcomes of patients undergoing laparoscopic sacrocolpopexy for vault/cervical prolapse.
Read the detailed description
The aim of this study is to audit the outcomes of laparoscopic sacrocolpopexy procedures done in our unit. The investigators aim to permanently monitor outcomes of this procedure correcting vaginal vault prolapse or cervical descent. Auditing institutional performance with pelvic floor procedures is increasingly being required by (inter)national societies in pelvic floor medicine, so that patients can be counseled on outcomes they can expect at a given institution.
Sacrocolpopexy is offered to patients with symptomatic prolapse (≥stage II) of the vaginal apex (vault or cervix). The procedure involves dissection of the promontory and the vaginal vault, suturing of two meshes to the anterior and posterior aspect of the vagina using minimally three rows of sutures on each side, and one row at the apex. Thereafter the mesh is fixed with staples to the promontory and the peritoneum closed, with staples and a running suture.
The investigators started auditing this procedure 20 years ago because of the conversion to laparoscopy.
High anatomical and subjective cure rates are reported on the medium term (range 12-60 months), though long-term data (60 months or longer) are scarce and most studies focus on anatomical outcomes.4 The investigators recently published medium term outcomes of patients operated up to 2014 1. Now the aim is to extend this audit to patients operated since 2014 and install a process of permanent monitoring our performance with this operation. The investigators also want to use the availability of outcomes in large numbers and/or the long term, to detect potential rare or long term complications, and study the effects of small technical increments such as extending dissections, associate other pelvic floor reconstructive procedures or the change in bio-materials used for this operation. All these may affect outcome.
Primary outcome is a subjective outcome, using a patient-centered approach and report patient reported out-comes. Additional outcomes such as anatomical failure, or complications, both by occurrence and time point, re-interventions, and pelvic floor functional outcomes are secondary outcomes that allows the investigators to benchmark their performance to previous studies and other series. Key in an objective assessment process is that patients are examined by an experienced clinician not involved in the management, which will also be used herein.
- Conditions
- Vault Prolapse, Vaginal
- Being tested
- Sacrocolpopexy
- Keywords
- sacropexy, audit
- 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.
SacrocolpopexyProcedure or surgery
Sacrocolpopexy is offered to patients with symptomatic prolapse (≥stage II) of the vaginal apex (vault or cervix). The procedure involves dissection of the promontory and the vaginal vault, suturing of two meshes to the anterior and posterior aspect of the vagina using minimally three rows of sutures on each side, and one row at the apex. Thereafter the mesh is fixed with staples to the promontory and the peritoneum closed, with staples and a running suture.
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Success Rate
Subjective Success assessed by the Patient Global Impression of Change (PGI-C) tool, which is a 5-point Likert scale, where the patients are asked the following question at the follow up visit: "Compared with how you were doing before your recent pelvic floor operation, would you say that now you are: "much better", "a little better", "about the same", "a little worse" or "much worse".
Measured: Up to 10 years postoperative
Secondary outcomes (5)
Objective success
Objective Success will be defined as: achievement of a POP-Q score Stage ≤1, without re-intervention for POP or graft related complication at approximately 12 months.
Measured: Up to 10 years postoperative
Postoperative complications
Occurrence of operative complications: classified as either intra-operative or postoperative (within 3 months of operation), and according to the Dindo classification, as we earlier did.
Measured: Up to 10 years postoperative
Reintervention rate
Reintervention for prolapse as well as its compartment, at any time point during follow up. The time point of reintervention will be a variable per se.
Measured: Up to 10 years postoperative
Postoperative graft related complications (GRC)
Postoperative graft related complications (GRC) out of a (non-limitative) list of de novo dyspareunia, worsening of pre-existing dyspareunia, incidence of chronic pain, occurrence of exposure, extrusion or any other complication and any reintervention because of the above. GRC will be categorized according to the IUGA classification
Measured: Up to 10 years postoperative
Prolapse Quality of Life (P-QoL)
P-QoL: self-reported severity of symptoms in patients with urogenital prolapse and their impact on 9 different quality of life domains with scores for each domain, ranging between 0 and 100. Higher scores indicate a greater impairment of quality of life. This has been validated for the Flemish population
Measured: Up to 10 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start29 Sep 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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 Vault Prolapse, VaginalStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Jan Deprest, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378400
- Sponsor's protocol ID
- S63523
- Status last verified
- Jan 2025
- First submitted
- 4 May 2020
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Page AS, Cattani L, Pacquee S, Claerhout F, Callewaert G, Housmans S, Van der Aa F, D'Hoore A, Deprest J. Long-term Data on Graft-Related Complications After Sacrocolpopexy With Lightweight Compared With Heavier-Weight Mesh. Obstet Gynecol. 2023 Jan 1;141(1):189-198. doi: 10.1097/AOG.0000000000005021. Epub 2022 Nov 30.
PubMed 36701619
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Institutional Audit of the Short Term Complications and Long Term Outcomes of Patients Undergoing Laparoscopic Sacrocolpopexy for Vault/cervical Prolapse.
- ClinicalTrials.gov ID
- NCT04378400
- Acronym / sponsor ID
- S63523
- Conditions
- Vault Prolapse, Vaginal
- Keywords
- sacropexy, audit
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 May 2020 (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.
An institutional audit of the short term complications and long term outcomes of patients undergoing laparoscopic sacrocolpopexy for vault/cervical prolapse.
Detailed description
The aim of this study is to audit the outcomes of laparoscopic sacrocolpopexy procedures done in our unit. The investigators aim to permanently monitor outcomes of this procedure correcting vaginal vault prolapse or cervical descent. Auditing institutional performance with pelvic floor procedures is increasingly being required by (inter)national societies in pelvic floor medicine, so that patients can be counseled on outcomes they can expect at a given institution.
Sacrocolpopexy is offered to patients with symptomatic prolapse (≥stage II) of the vaginal apex (vault or cervix). The procedure involves dissection of the promontory and the vaginal vault, suturing of two meshes to the anterior and posterior aspect of the vagina using minimally three rows of sutures on each side, and one row at the apex. Thereafter the mesh is fixed with staples to the promontory and the peritoneum closed, with staples and a running suture.
The investigators started auditing this procedure 20 years ago because of the conversion to laparoscopy.
High anatomical and subjective cure rates are reported on the medium term (range 12-60 months), though long-term data (60 months or longer) are scarce and most studies focus on anatomical outcomes.4 The investigators recently published medium term outcomes of patients operated up to 2014 1. Now the aim is to extend this audit to patients operated since 2014 and install a process of permanent monitoring our performance with this operation. The investigators also want to use the availability of outcomes in large numbers and/or the long term, to detect potential rare or long term complications, and study the effects of small technical increments such as extending dissections, associate other pelvic floor reconstructive procedures or the change in bio-materials used for this operation. All these may affect outcome.
Primary outcome is a subjective outcome, using a patient-centered approach and report patient reported out-comes. Additional outcomes such as anatomical failure, or complications, both by occurrence and time point, re-interventions, and pelvic floor functional outcomes are secondary outcomes that allows the investigators to benchmark their performance to previous studies and other series. Key in an objective assessment process is that patients are examined by an experienced clinician not involved in the management, which will also be used herein.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Since our last audit (April 30, 2014), we have operated on more than probably another 250 patients, who will be contacted. Based on our previous experience, we expect a 85% response rate.
Key inclusion criteria (4 listed)
- Having undergone laparoscopic sacrocolpoexy at our unit.
- Agreeing to participate in the study, including completion of study-related procedures, evaluations and questionnaires, and giving informed consent.
- Follow up period of at least 6 months since the operation.
Key exclusion criteria (1 listed)
- None apart from not meeting the above criteria
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 |
|---|---|---|
| SacrocolpopexySacrocolpopexy is offered to patients with symptomatic prolapse (≥stage II) of the vaginal apex (vault or cervix). The procedure involves dissection of the promontory and the vaginal vault, suturing of two meshes to the anterior and posterior aspect of the vagina using minimally three rows of sutures on each side, and one row at the apex. Thereafter the mesh is fixed with staples to the promontory and the peritoneum closed, with staples and a running suture. | Procedure or surgery | – |
Primary outcome
Subjective Success Rate
Time frame: Up to 10 years postoperative
Subjective Success assessed by the Patient Global Impression of Change (PGI-C) tool, which is a 5-point Likert scale, where the patients are asked the following question at the follow up visit: "Compared with how you were doing before your recent pelvic floor operation, would you say that now you are: "much better", "a little better", "about the same", "a little worse" or "much worse".
5 secondary outcomes
Objective success
Time frame: Up to 10 years postoperative
Postoperative complications
Time frame: Up to 10 years postoperative
Reintervention rate
Time frame: Up to 10 years postoperative
Postoperative graft related complications (GRC)
Time frame: Up to 10 years postoperative
Prolapse Quality of Life (P-QoL)
Time frame: Up to 10 years postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Derived from this study: PubMed 36701619Page AS, Cattani L, Pacquee S, Claerhout F, Callewaert G, Housmans S, Van der Aa F, D'Hoore A, Deprest J. Long-term Data on Graft-Related Complications After Sacrocolpopexy With Lightweight Compared With Heavier-Weight Mesh. Obstet Gynecol. 2023 Jan 1;141(1):189-198. doi: 10.1097/AOG.0000000000005021. Epub 2022 Nov 30.
- Individual participant dataSharing planned: No
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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.
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?
An observational study of Vault Prolapse, Vaginal, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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: enrolling by invitation, as of the sponsor's last update on 15 Jan 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Subjective Success Rate (time frame: Up to 10 years postoperative). 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 NCT04378400, 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 15 Jan 2025.