Uterovaginal ProlapsePROLAPSENCT02877407
Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse
A study testing patient who undergo laparoscopic/robotic-assisted hysteropexy and patient who undergo vaginal hysterectomy in people with Uterovaginal Prolapse and Hysteropexy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal hysterectomy for uterine prolapse prospective randomized clinical trial patient 1. 60yrs or more women and 2. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Uterovaginal Prolapse, Hysteropexy
- What is being tested?
- patient who undergo laparoscopic/robotic-assisted hysteropexy and patient who undergo vaginal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to Jun 2017
- Phase
- Interventional
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- POP-Q stage II with symptom or POP-Q III, IV regardless of symptom
Who cannot join
- abnormal uterine bleeding
- significantly enlarged fibroid uterus
- postmenopausal uterine bleeding
- endometrial pathology
- on tamexifen
- concomitant medical problems precluding general anesthesia or surgery
- damaged agreement ability
Trial locations and contacts
1 site in 1 country.
Dong Hun Suh, associate professor contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National Univesity Bundang Hospital
Seongnam-si, Kyeonggi-do, 13620
Dong Hun Suh, associate professor
About this study
Official title: A Randomized Controlled Study of Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse
- objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal hysterectomy for uterine prolapse
- prospective randomized clinical trial
- patient
- 60yrs or more women and
- POP-Q stage II with symptom or POP-Q III, IV regardless of symptom
- number of patient: 146
- randomize: laparoscopic/robot-assisted hysteropexy vs. hysterectomy
- follow up: postoperative 1 year
- primary endpoint: recurrence rate
- recurrence of uterovaginal prolapse POP-Q stage II-IV
- recurrence of associated symptom
- secondary endpoint
- postoperative 1 year QOL, degree of satisfaction evaluation
- operative time, estimated blood loss
- hospitalization period, postoperative pain, return to normal activity
- Conditions
- Uterovaginal Prolapse, Hysteropexy
- Being tested
- patient who undergo laparoscopic/robotic-assisted hysteropexy, patient who undergo vaginal hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient who undergo laparoscopic/robotic-assisted hysteropexyProcedure or surgery
patient who undergo vaginal hysterectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic/robotic-assisted hysteropexy | Other | patient who undergo laparoscopic/robotic-assisted hysteropexy Receives: Procedure: patient who undergo laparoscopic/robotic-assisted hysteropexy |
| vaginal hysterectomy | Other | patient who undergo vaginal hysterectomy Receives: Procedure: patient who undergo vaginal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate (%)
recurrence rate(%) of uterovaginal prolapse POP-Q stage II-IV in postoperative 1 year
Measured: postoperative 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (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 Uterovaginal ProlapseStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Hoon Suh, Seoul National University Hospital
- Investigators
- Dong Hun Suh, associate professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877407
- Sponsor's protocol ID
- B-1605/345-002
- Acronym
- PROLAPSE
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
Publications
Hwang WY, Jeon MJ, Suh DH. Minimally Invasive Sacrohysteropexy Versus Vaginal Hysterectomy With Uterosacral Ligament Suspension for Pelvic Organ Prolapse: A Prospective Randomized Non-Inferiority Trial. J Minim Invasive Gynecol. 2024 May;31(5):406-413. doi: 10.1016/j.jmig.2024.01.018. Epub 2024 Feb 8.
PubMed 38336010
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse
- ClinicalTrials.gov ID
- NCT02877407
- Acronym / sponsor ID
- PROLAPSE / B-1605/345-002
- Conditions
- Uterovaginal Prolapse, Hysteropexy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Aug 2016 (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.
- objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal hysterectomy for uterine prolapse
- prospective randomized clinical trial
- patient
- 60yrs or more women and
- POP-Q stage II with symptom or POP-Q III, IV regardless of symptom
- number of patient: 146
- randomize: laparoscopic/robot-assisted hysteropexy vs. hysterectomy
- follow up: postoperative 1 year
- primary endpoint: recurrence rate
- recurrence of uterovaginal prolapse POP-Q stage II-IV
- recurrence of associated symptom
- secondary endpoint
- postoperative 1 year QOL, degree of satisfaction evaluation
- operative time, estimated blood loss
- hospitalization period, postoperative pain, return to normal activity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic/robotic-assisted hysteropexy | Other | Procedure: patient who undergo laparoscopic/robotic-assisted hysteropexypatient who undergo laparoscopic/robotic-assisted hysteropexy |
| vaginal hysterectomy | Other | Procedure: patient who undergo vaginal hysterectomypatient who undergo vaginal hysterectomy |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- POP-Q stage II with symptom or POP-Q III, IV regardless of symptom
Key exclusion criteria (7 listed)
- abnormal uterine bleeding
- significantly enlarged fibroid uterus
- postmenopausal uterine bleeding
- endometrial pathology
- on tamexifen
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 |
|---|---|---|
| patient who undergo laparoscopic/robotic-assisted hysteropexy | Procedure or surgery | laparoscopic/robotic-assisted hysteropexy |
| patient who undergo vaginal hysterectomy | Procedure or surgery | vaginal hysterectomy |
Primary outcome
recurrence rate (%)
Time frame: postoperative 1 year
recurrence rate(%) of uterovaginal prolapse POP-Q stage II-IV in postoperative 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Derived from this study: PubMed 38336010Hwang WY, Jeon MJ, Suh DH. Minimally Invasive Sacrohysteropexy Versus Vaginal Hysterectomy With Uterosacral Ligament Suspension for Pelvic Organ Prolapse: A Prospective Randomized Non-Inferiority Trial. J Minim Invasive Gynecol. 2024 May;31(5):406-413. doi: 10.1016/j.jmig.2024.01.018. Epub 2024 Feb 8.
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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.
Dong Hun Suh, associate professor contact
Dong Hun Suh, associate professor principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient who undergo laparoscopic/robotic-assisted hysteropexy and patient who undergo vaginal hysterectomy in people with Uterovaginal Prolapse and Hysteropexy, run by Seoul National University Hospital at 1 site in South Korea.
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 7 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 25 Aug 2016. 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 South Korea. 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 Dong Hun Suh, associate professor (sdhwcj@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate (%) (time frame: postoperative 1 year). 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 NCT02877407, 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 25 Aug 2016.