Pelvic Organ ProlapseNCT02465658
Risk Factors for Co-existence of Cervical Elongation in Uterine Prolapse
An observational study of Pelvic Organ Prolapse, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The presence of co-existence of cervical elongation in women of uterine prolapse may decrease the patients' satisfaction of uterine-preservation surgery for uterine prolapse, and additional surgery, such as Manchester surgery, may be needed to solve the problem.Thus the aim of this study is to investigate the risk… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Medical records were reviewed.
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2015to Mar 2016
- 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: Women with uterine prolapse and underwent vaginal total hysterectomy
Who may be able to join
- All women with uterine prolapse underwent vaginal total hysterectomy
- > 20 years old.
Who cannot join
- nil
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics & Gynecology, National Taiwan University Hospital
Taipei, Taiwan, 100
Ho-Hsiung Lin, MD, PhD, 886-2-23123456 ext. 71557, hhlin@ntuh.gov.tw
Sheng-Mou Hsiao, 886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
The presence of co-existence of cervical elongation in women of uterine prolapse may decrease the patients' satisfaction of uterine-preservation surgery for uterine prolapse, and additional surgery, such as Manchester surgery, may be needed to solve the problem.Thus the aim of this study is to investigate the risk factors of co-existence of cervical elongation in uterine prolapse.
Read the detailed description
Purpose:
Thus the aim of this study is to investigate the risk factors of co-existence of cervical elongation in uterine prolapse.
Patients and Methods:
Between January 1994 and October 2014, all women underwent vaginal total hysterectomy in a medical center were enrolled in this study. Medical records were reviewed. Cervical elongation is defined as the presence of cervical length >3.38 cm or cervix to corpus ratio >0.79.
Expected Results:
The investigators will get the risk factors of co-existence of cervical elongation in uterine prolapse, and the result should be helpful for preoperative consultation, especially for uterine-preserving pelvic floor reconstruction surgery.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Medical records were reviewed.
- Keywords
- uterine prolapse, cervical elongation, pelvic floor reconstruction surgery
- 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.
Medical records were reviewed.Other
retrospective study
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors associated with coexistent cervical elongation in cases with uterine prolapse
Medical record review
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (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.
- More trials run by National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465658
- Sponsor's protocol ID
- 201503073RIND
- Status last verified
- Dec 2015
- First submitted
- 4 Jun 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Co-existence of Cervical Elongation in Uterine Prolapse
- ClinicalTrials.gov ID
- NCT02465658
- Acronym / sponsor ID
- 201503073RIND
- Conditions
- Pelvic Organ Prolapse
- Keywords
- uterine prolapse, cervical elongation, pelvic floor reconstruction surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 8 Jun 2015 (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 presence of co-existence of cervical elongation in women of uterine prolapse may decrease the patients' satisfaction of uterine-preservation surgery for uterine prolapse, and additional surgery, such as Manchester surgery, may be needed to solve the problem.Thus the aim of this study is to investigate the risk factors of co-existence of cervical elongation in uterine prolapse.
Detailed description
Purpose:
Thus the aim of this study is to investigate the risk factors of co-existence of cervical elongation in uterine prolapse.
Patients and Methods:
Between January 1994 and October 2014, all women underwent vaginal total hysterectomy in a medical center were enrolled in this study. Medical records were reviewed. Cervical elongation is defined as the presence of cervical length >3.38 cm or cervix to corpus ratio >0.79.
Expected Results:
The investigators will get the risk factors of co-existence of cervical elongation in uterine prolapse, and the result should be helpful for preoperative consultation, especially for uterine-preserving pelvic floor reconstruction surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with uterine prolapse and underwent vaginal total hysterectomy
Key inclusion criteria (2 listed)
- All women with uterine prolapse underwent vaginal total hysterectomy
- > 20 years old.
Key exclusion criteria (1 listed)
- nil
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 |
|---|---|---|
| Medical records were reviewed.retrospective study | Other | – |
Primary outcome
Factors associated with coexistent cervical elongation in cases with uterine prolapse
Time frame: 1 day
Medical record review
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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 National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 16 Dec 2015. 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 Taiwan. 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 Ho-Hsiung Lin, MD,PhD (886-2-23123456 ext. 71557, hhlin@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors associated with coexistent cervical elongation in cases with uterine prolapse (time frame: 1 day). 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 16 Dec 2015.