Pelvic Organ ProlapseNCT06802497
Comparison of Postoperative Outcomes of Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension With the Salman Ketenci Gencer Technique
An observational study of Pelvic Organ Prolapse, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of Early Postoperative Outcomes of Patients Undergoing Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension with the Salman Ketenci Gencer Technique Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jul 2024to 1 Dec 2025
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study planned to include 84 patients with pelvic organ prolapse.
Who may be able to join
- Patients with stage 3 or 4 pelvic organ prolapse Sexually active patients
Who cannot join
- Cervical pathology History of loop electrosurgical excision procedure (LEEP) or conization Presence of vaginal, pelvic, or adnexal mass Suspicious abdominal malignancy Morbid obesity Any pelvic infection Signs of pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpaşa Training and Research Hospital
Istanbul
Fatma Ketenci Gencer, associate professor, +905416116469, fathma_k@hotmail.com
Havva Betül Bacak, Specialist, +905333610088, hbbacak90@gmail.com
About this study
Official title: Comparison of Early Postoperative Outcomes of Patients Undergoing Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension With the Salman Ketenci Gencer Technique
Comparison of Early Postoperative Outcomes of Patients Undergoing Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension with the Salman Ketenci Gencer Technique
- Conditions
- Pelvic Organ Prolapse
- Keywords
- laparoscopy, v-notes lateral suspension, pelvic organ prolapse
- 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.
| Study group | Role | What they receive |
|---|---|---|
| patients underwent laparoscopic lateral suspension | Not described | |
| patients underwent V-NOTES lateral suspension with SalmanKetenciGencer technique | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Improvement in Pelvic Organ Prolapse (POP) Severity by POP-Q Score
POP-Q measurements assess the degree of pelvic organ prolapse in patients, using a combined system that includes multiple parameters to evaluate the anterior and posterior vaginal walls, cervix, and vaginal vault. This study will compare the POP-Q values of patients following laparoscopic lateral suspension and V-Notes lateral suspension with the Salmanketencigencer technique to assess improvements in prolapse severity.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start12 Jul 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
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
- Retrospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802497
- Sponsor's protocol ID
- GaziosmanpasaTREHfkg
- Status last verified
- Jul 2024
- First submitted
- 4 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Postoperative Outcomes of Patients Undergoing Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension With the Salman Ketenci Gencer Technique
- ClinicalTrials.gov ID
- NCT06802497
- Acronym / sponsor ID
- GaziosmanpasaTREHfkg
- Conditions
- Pelvic Organ Prolapse
- Keywords
- laparoscopy, v-notes lateral suspension, pelvic organ prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 31 Jan 2025 (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.
Comparison of Early Postoperative Outcomes of Patients Undergoing Laparoscopic Lateral Suspension and V-NOTES Lateral Suspension with the Salman Ketenci Gencer Technique
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients underwent laparoscopic lateral suspension | – | – |
| patients underwent V-NOTES lateral suspension with SalmanKetenciGencer technique | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study planned to include 84 patients with pelvic organ prolapse.
Key inclusion criteria (1 listed)
- Patients with stage 3 or 4 pelvic organ prolapse Sexually active patients
Key exclusion criteria (1 listed)
- Cervical pathology History of loop electrosurgical excision procedure (LEEP) or conization Presence of vaginal, pelvic, or adnexal mass Suspicious abdominal malignancy Morbid obesity Any pelvic infection Signs of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Improvement in Pelvic Organ Prolapse (POP) Severity by POP-Q Score
Time frame: 6 months
POP-Q measurements assess the degree of pelvic organ prolapse in patients, using a combined system that includes multiple parameters to evaluate the anterior and posterior vaginal walls, cervix, and vaginal vault. This study will compare the POP-Q values of patients following laparoscopic lateral suspension and V-Notes lateral suspension with the Salmanketencigencer technique to assess improvements in prolapse severity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
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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.
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 Pelvic Organ Prolapse, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 1 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: status not confirmed, as of the sponsor's last update on 31 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Ketenci Gencer, Associate Professor (+905416116469, fathma_k@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Improvement in Pelvic Organ Prolapse (POP) Severity by POP-Q Score (time frame: 6 months). 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 Jan 2025.