Modified Extraperitoneal Uterosacral Ligament SuspensionNCT03832543
Modified Uterosacral Ligament Suspension in Vaginal Hysterectomy
An observational study of Modified Extraperitoneal Uterosacral Ligament Suspension and Vault Prolapse, Vaginal, run by Kanuni Sultan Suleyman Training and Research Hospital.
Trial summary
Introduction : The extraperitoneal uterosacral ligament suspension (ULS) can be performed during the removal of the uterus in vaginal hysterectomy to prevent cuff prolapse. In this study, the modified extraperitoneal ULS technique was evaluated in terms of preventing cuff prolapse. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Modified Extraperitoneal Uterosacral Ligament Suspension, Vault Prolapse, Vaginal
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 Dec 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 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Stage 2 or 3 uterin prolapse who need surgery
Who may be able to join
- Stage 2 or 3 uterin prolapse
Who cannot join
- contrandication for surgery
About this study
Official title: Modified Extraperitoneal Uterosacral Ligament Suspension in Preventing Cuff Prolapse Risk After Vaginal Hysterectomy; 4 Clamp Method
Introduction : The extraperitoneal uterosacral ligament suspension (ULS) can be performed during the removal of the uterus in vaginal hysterectomy to prevent cuff prolapse. In this study, the modified extraperitoneal ULS technique was evaluated in terms of preventing cuff prolapse.
Methods / Technique : Forty patients with second and third-stage uterine prolapse who were operated were included in the study. During routine vaginal hysterectomy procedure performed on patients, after sacrouterine ligaments which are the first-bites and uteroovarian and round ligaments which are the last-bites have been sutured and knotted, these ligaments were marked with 4-distinct clemps to make the right and left, upper and lower separation. After vaginal cuff was closed the sutures hanged by the clamps were ligated together, and the cuff tissue was stretched to the apical line.
- Keywords
- Vaginal Hysterectomy
- Medical subject headings
- Pelvic Organ Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative vaginal cuff prolapse
During two years follow up after sugery if there is vaginal cuff prolapse or not. The measurement of the vaginal cuff distance to the hymenal ring with a calculator. The units were centimeter
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Apr 2016
- Primary completion1 May 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modified Extraperitoneal Uterosacral Ligament SuspensionStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerem Doga Seckin, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832543
- Sponsor's protocol ID
- 0651603
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2019
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Extraperitoneal Uterosacral Ligament Suspension in Preventing Cuff Prolapse Risk After Vaginal Hysterectomy; 4 Clamp Method
- ClinicalTrials.gov ID
- NCT03832543
- Acronym / sponsor ID
- 0651603
- Keywords
- Vaginal Hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 6 Feb 2019 (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.
Introduction : The extraperitoneal uterosacral ligament suspension (ULS) can be performed during the removal of the uterus in vaginal hysterectomy to prevent cuff prolapse. In this study, the modified extraperitoneal ULS technique was evaluated in terms of preventing cuff prolapse.
Methods / Technique : Forty patients with second and third-stage uterine prolapse who were operated were included in the study. During routine vaginal hysterectomy procedure performed on patients, after sacrouterine ligaments which are the first-bites and uteroovarian and round ligaments which are the last-bites have been sutured and knotted, these ligaments were marked with 4-distinct clemps to make the right and left, upper and lower separation. After vaginal cuff was closed the sutures hanged by the clamps were ligated together, and the cuff tissue was stretched to the apical line.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage 2 or 3 uterin prolapse who need surgery
Key inclusion criteria (1 listed)
- Stage 2 or 3 uterin prolapse
Key exclusion criteria (1 listed)
- contrandication for surgery
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 vaginal cuff prolapse
Time frame: 2 years
During two years follow up after sugery if there is vaginal cuff prolapse or not. The measurement of the vaginal cuff distance to the hymenal ring with a calculator. The units were centimeter
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 8 Feb 2019.
- Individual participant dataSharing planned: No
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 Modified Extraperitoneal Uterosacral Ligament Suspension and Vault Prolapse, Vaginal, run by Kanuni Sultan Suleyman Training and Research Hospital.
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: finished, as of the sponsor's last update on 8 Feb 2019. 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?
postoperative vaginal cuff prolapse (time frame: 2 years). 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 8 Feb 2019.