Uterine Myoma, Ovary Neoplasm, AdenomyosisPhase 3PONVNCT02011659
Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy
A Phase 3 study testing Ramosetron in people with Uterine Myoma, Ovary Neoplasm, Adenomyosis, run by National Health Insurance Service Ilsan Hospital at 1 site in South Korea.
Trial summary
To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic patients undergoing laparoscopic surgery after scheduled administration of intravenous Ramosetron during hospital stays. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Uterine Myoma, Ovary Neoplasm, Adenomyosis
- What is being tested?
- Ramosetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Nov 2015
- Phase
- Phase 3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18< or =, = or <70 with benign gynecologic disease
- ASA-Class I-II
- No-definite malignancy by US, CT/MRI, CA 125 < 500IU/ml
- Non-smoker
Who cannot join
- Conversion to laparotomy
- Hx of malignancy
- Smoker
- Suspicious malignancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Health Insurance Service Ilsan Hospital
Goyang-si, 410-719
San-Hui Lee, M.D.
About this study
Official title: A Randomized Prospective Study of Scheduled Intravenous Ramosetron for the Prevention of Nausea and Vomiting in Hospitalized Patients After Gynecologic Laparoscopy
To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic patients undergoing laparoscopic surgery after scheduled administration of intravenous Ramosetron during hospital stays.
- Randomized controlled arm : Placebo versus Ramosetron injection
- Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs after surgery
Read the detailed description
Surgical outcomes including operative time, blood loss, Hb change, postoperative pain, nausea/vomiting scale, times of rescue therapy, and complications
- Being tested
- Ramosetron
- Keywords
- Ramosetron, postoperative nausea and vomiting, laparoscopy
- Medical subject headings
- Myofibroma, Ovarian Neoplasms, Adenomyosis, Postoperative Nausea and Vomiting, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamosetronDrug
| Study group | Role | What they receive |
|---|---|---|
| Ramosetron | Active comparator | Not described Receives: Drug: Ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence or intensity of PONV
Measured: during postoperative hospital stays (2 days)
Secondary outcomes (1)
Adverse reaction associated with Ramosetron injection
Measured: Postoperatvie 7 days (at OPD based)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2015 (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 Uterine Myoma, Ovary Neoplasm, AdenomyosisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Insurance Service Ilsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, San-Hui Lee, National Health Insurance Service Ilsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011659
- Sponsor's protocol ID
- PONV-NHIS-GYN-001
- Acronym
- PONV
- Status last verified
- Dec 2013
- First submitted
- 10 Dec 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li SC, Wang Y, Choi SJ, Jung YS, Han KH, Chung IB, Lee SH. Scheduled injection of ramosetron for prevention of nausea and vomiting following single-port access total laparoscopic hysterectomy: a prospective randomized study. Obstet Gynecol Sci. 2019 Sep;62(5):344-351. doi: 10.5468/ogs.2019.62.5.344. Epub 2019 Jul 23.
PubMed 31538078
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Study of Scheduled Intravenous Ramosetron for the Prevention of Nausea and Vomiting in Hospitalized Patients After Gynecologic Laparoscopy
- ClinicalTrials.gov ID
- NCT02011659
- Acronym / sponsor ID
- PONV / PONV-NHIS-GYN-001
- Keywords
- Ramosetron, postoperative nausea and vomiting, laparoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- National Health Insurance Service Ilsan HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2015 (estimated)
- First posted
- 13 Dec 2013 (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.
To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic patients undergoing laparoscopic surgery after scheduled administration of intravenous Ramosetron during hospital stays.
- Randomized controlled arm : Placebo versus Ramosetron injection
- Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs after surgery
Detailed description
Surgical outcomes including operative time, blood loss, Hb change, postoperative pain, nausea/vomiting scale, times of rescue therapy, and complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramosetron | Active comparator | Drug: Ramosetron |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18< or =, = or <70 with benign gynecologic disease
- ASA-Class I-II
- No-definite malignancy by US, CT/MRI, CA 125 < 500IU/ml
- Non-smoker
Key exclusion criteria (4 listed)
- Conversion to laparotomy
- Hx of malignancy
- Smoker
- Suspicious malignancy
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 |
|---|---|---|
| Ramosetron | Drug | Ramosetron |
Primary outcome
Incidence or intensity of PONV
Time frame: during postoperative hospital stays (2 days)
1 secondary outcome
Adverse reaction associated with Ramosetron injection
Time frame: Postoperatvie 7 days (at OPD based)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Derived from this study: PubMed 31538078Li SC, Wang Y, Choi SJ, Jung YS, Han KH, Chung IB, Lee SH. Scheduled injection of ramosetron for prevention of nausea and vomiting following single-port access total laparoscopic hysterectomy: a prospective randomized study. Obstet Gynecol Sci. 2019 Sep;62(5):344-351. doi: 10.5468/ogs.2019.62.5.344. Epub 2019 Jul 23.
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?
A Phase 3 study testing Ramosetron in people with Uterine Myoma, Ovary Neoplasm, Adenomyosis, run by National Health Insurance Service Ilsan 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 4 inclusion and 4 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 13 Dec 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 San-Hui Lee, M.D. (+82-900-0218, sanaram@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence or intensity of PONV (time frame: during postoperative hospital stays (2 days)). 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 NCT02011659, 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 13 Dec 2013; AzTrials last refreshed its copy on 7 Nov 2026.