Pelvic Organ ProlapseNCT04894032
Combination of Laparoskopic Uterosacral Ligament and Round Ligament Plication, A Meshless Method in the Surgical Treatment of Pelvic Organ Prolapse.
An observational study of Pelvic Organ Prolapse and Prolapse Uterus, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative Results of a Meshless Method in the Surgical Treatment of Pelvic Organ Prolapse; Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication. Read more about this study
- Who is it for?
- Ages 30 to 85 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Prolapse Uterus, Prolapse Bladder
- What is being tested?
- Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2021to 6 Jan 2022
- 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 85 years
- Women only
- Adult, Older adult
Study population: Fmale patients with the complaint of prolapse of the genital organs, who do not respond or not willing to take conservative treatment and have Stage 2 or higher pelvic organ prolapse according to POP-Q staging system and who have completed the fertility period
Who may be able to join
- Female patients age between 30 to 85
- Having Stage 2 or higher pelvic organ prolapse according to POP-Q staging system
- Patients who accept the surgical treatment
Who cannot join
- Patients who have a gynecological malignancy
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zeynep Kamil Maternity and Childrens Training and Research Hospital
Istanbul, 34668
Sultan Seren Karakus, MD, 00905355660095, serensultan@hotmail.com
About this study
Official title: Postoperative Results of a Meshless Method in the Surgical Treatment of Pelvic Organ Prolapse; Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.
Postoperative Results of a Meshless Method in the Surgical Treatment of Pelvic Organ Prolapse; Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.
Read the detailed description
Following the approval of the ethics committee, Female patients admitted to Urogynecology and Gynecology Outpatient Clinic of Zeynep Kamil Gynecology and Child Diseases Education and Research Hospital with the complaint of prolapse of the genital organs, who do not respond or not willing to take conservative treatment and have Stage 2 or higher pelvic organ prolapse according to POP-Q staging system and who have completed the fertility period will be included in our study. Patients Age, gravida and parity of the patients, menopausal status, whether she is hysterectomized, the stage of prolapse according to POP-Q and other gynecological examination findings will be recorded.Patients will be asked about preoperative urinary system pathologies (voiding dysfunction, urinary incontinence, recurrent UTI) and Urodynamic examination will be done accordingly.
Prolapsus and its Impact on the quality of life will be recorded preoperatively with quality of life questionnaires.At the early postoperative period and preoperatively, the duration of the operation, blood loss during the surgery, VAS score , and the presence of complications will be recorded. Patients will be called postoperatively for control examination at the 1st month , 6th month , 1st year and subsequently annual control will be done.Objective success; Stage 1 according to POP-Q or no prolapse. Subjective success will be accepted once the patient has no prolapse-related complaints.In the postoperative period, whether there is any change in urinary system and sexual functions will be questioned with the help of questionnaires.Laparoscopic Uterosacral Ligament plication, fixation of PVC fascia and the combination with round ligament plication will be evaluated in terms of efficacy and reliability.
- Conditions
- Pelvic Organ Prolapse, Prolapse Uterus, Prolapse Bladder
- Being tested
- Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.Procedure or surgery
Laparoscopic Uterosacral Ligament Plication, Fixation of PVC fascia and the combination with round ligament plication
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent rate after a meshless method in pelvic prolapse surgery
Combination of Laparoskopic Uterosacral Ligament and Round Ligament plication
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start6 Jan 2021
- Primary completion6 Jan 2022 (estimated)
- Study completion6 Jan 2022 (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
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan Seren Karakus, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894032
- Sponsor's protocol ID
- 9/2021
- Status last verified
- May 2021
- First submitted
- 5 Apr 2021
- Last updated
- 20 May 2021
- 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 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Results of a Meshless Method in the Surgical Treatment of Pelvic Organ Prolapse; Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.
- ClinicalTrials.gov ID
- NCT04894032
- Acronym / sponsor ID
- 9/2021
- Conditions
- Pelvic Organ Prolapse, Prolapse Uterus, Prolapse Bladder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 6 Jan 2022 (estimated)
- Study completion
- 6 Jan 2022 (estimated)
- First posted
- 20 May 2021 (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.
Postoperative Results of a Meshless Method in the Surgical Treatment of Pelvic Organ Prolapse; Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.
Detailed description
Following the approval of the ethics committee, Female patients admitted to Urogynecology and Gynecology Outpatient Clinic of Zeynep Kamil Gynecology and Child Diseases Education and Research Hospital with the complaint of prolapse of the genital organs, who do not respond or not willing to take conservative treatment and have Stage 2 or higher pelvic organ prolapse according to POP-Q staging system and who have completed the fertility period will be included in our study. Patients Age, gravida and parity of the patients, menopausal status, whether she is hysterectomized, the stage of prolapse according to POP-Q and other gynecological examination findings will be recorded.Patients will be asked about preoperative urinary system pathologies (voiding dysfunction, urinary incontinence, recurrent UTI) and Urodynamic examination will be done accordingly.
Prolapsus and its Impact on the quality of life will be recorded preoperatively with quality of life questionnaires.At the early postoperative period and preoperatively, the duration of the operation, blood loss during the surgery, VAS score , and the presence of complications will be recorded. Patients will be called postoperatively for control examination at the 1st month , 6th month , 1st year and subsequently annual control will be done.Objective success; Stage 1 according to POP-Q or no prolapse. Subjective success will be accepted once the patient has no prolapse-related complaints.In the postoperative period, whether there is any change in urinary system and sexual functions will be questioned with the help of questionnaires.Laparoscopic Uterosacral Ligament plication, fixation of PVC fascia and the combination with round ligament plication will be evaluated in terms of efficacy and reliability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Fmale patients with the complaint of prolapse of the genital organs, who do not respond or not willing to take conservative treatment and have Stage 2 or higher pelvic organ prolapse according to POP-Q staging system and who have completed the fertility period
Key inclusion criteria (3 listed)
- Female patients age between 30 to 85
- Having Stage 2 or higher pelvic organ prolapse according to POP-Q staging system
- Patients who accept the surgical treatment
Key exclusion criteria (2 listed)
- Patients who have a gynecological malignancy
- Pregnant patients
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 |
|---|---|---|
| Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.Laparoscopic Uterosacral Ligament Plication, Fixation of PVC fascia and the combination with round ligament plication | Procedure or surgery | – |
Primary outcome
recurrent rate after a meshless method in pelvic prolapse surgery
Time frame: Through study completion, an average of 6 months
Combination of Laparoskopic Uterosacral Ligament and Round Ligament plication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- 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. 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 and Prolapse Uterus, run by Zeynep Kamil Maternity and Pediatric Research and Training 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 3 inclusion and 2 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 20 May 2021. 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 Sultan Seren Karakuş, MD (00905355660095, serensultan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent rate after a meshless method in pelvic prolapse surgery (time frame: Through study completion, an average of 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 20 May 2021.