Menstrual IrregularityEarly Phase 1NCT04985591
The Effect of Liposuction on Menses: a Retrospective Study
A Early Phase 1 study testing Liposuction and Other plastic surgery in people with Menstrual Irregularity, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
The prevalence of obesity nearly tripled from 1975 to 2021, resulting in liposuction, as an effective shaping method, to be performed more frequently. Liposuction is a surgical procedure that uses a specialized instrument to suck fat fragments in the subcutaneous fat layer through a small incision. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Irregularity
- What is being tested?
- Liposuction and Other plastic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 516 participants
- Where
- No sites listed yet
- Study dates
- 14 Jun 2016to 12 Mar 2021
- Phase
- Early Phase 1
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria:patients who were in 18-55 and have a regular menses -
Exclusion Criteria:Patients who were younger than 18 years old or older than 55 years old, who were in the perimenopausal or postmenopausal stage or who had menstrual irregularity before plastic surgery were excluded from both groups.
-
About this study
The prevalence of obesity nearly tripled from 1975 to 2021, resulting in liposuction, as an effective shaping method, to be performed more frequently. Liposuction is a surgical procedure that uses a specialized instrument to suck fat fragments in the subcutaneous fat layer through a small incision. Analyzing a large sample sizes of patients who had liposuction, we found that some female patients underwent menstrual irregularity after liposuction. In 2004, Carolyn et al. reported several cases in which there was a connection between liposuction and an early onset of menses. Further studies showed that an early onset of menses may be related to the volume of adipose tissue extracted, the amount of anesthesia given, the area of liposuction, and body weight. However, the sample of that study was small, as there were only 17 cases included in the statistical model, and there are few articles in which the impact of liposuction on menses has been studied. To better understand whether menstrual irregularity will occur after liposuction, patients with postmenopausal or preoperative menstrual irregularity were excluded, leaving a sample of 518 female patients to be reviewed. A better understanding of the impact of liposuction on menses may help clinical doctors predict the underlying risk of menstrual irregularity after liposuction and identify individuals at higher risk. The findings may contribute to further understanding of menstrual irregularity.
- Conditions
- Menstrual Irregularity
- Being tested
- Liposuction, Other plastic surgery
- Medical subject headings
- Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiposuctionProcedure or surgery
A small, inconspicuous incision was made in the liposuction group to dislodge fat out of the body.
Other plastic surgeryProcedure or surgery
Other plastic surgery like blepharoplasty or keloid excision.
| Study group | Role | What they receive |
|---|---|---|
| liposuction group | Experimental | Not described Receives: Procedure: Liposuction |
| Other plastic surgery group | Placebo comparator | Not described Receives: Procedure: Other plastic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
menstrual irregularity
to detect any change in the menses during the following 3 months, post surgery
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start14 Jun 2016
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual IrregularityStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985591
- Sponsor's protocol ID
- SH9H-2019-T221-2
- Status last verified
- Jul 2021
- First submitted
- 22 Jul 2021
- Last updated
- 2 Aug 2021
- Results posted
- 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 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Liposuction on Menses: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04985591
- Acronym / sponsor ID
- SH9H-2019-T221-2
- Conditions
- Menstrual Irregularity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 2 Aug 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.
The prevalence of obesity nearly tripled from 1975 to 2021, resulting in liposuction, as an effective shaping method, to be performed more frequently. Liposuction is a surgical procedure that uses a specialized instrument to suck fat fragments in the subcutaneous fat layer through a small incision. Analyzing a large sample sizes of patients who had liposuction, we found that some female patients underwent menstrual irregularity after liposuction. In 2004, Carolyn et al. reported several cases in which there was a connection between liposuction and an early onset of menses. Further studies showed that an early onset of menses may be related to the volume of adipose tissue extracted, the amount of anesthesia given, the area of liposuction, and body weight. However, the sample of that study was small, as there were only 17 cases included in the statistical model, and there are few articles in which the impact of liposuction on menses has been studied. To better understand whether menstrual irregularity will occur after liposuction, patients with postmenopausal or preoperative menstrual irregularity were excluded, leaving a sample of 518 female patients to be reviewed. A better understanding of the impact of liposuction on menses may help clinical doctors predict the underlying risk of menstrual irregularity after liposuction and identify individuals at higher risk. The findings may contribute to further understanding of menstrual irregularity.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liposuction group | Experimental | Procedure: Liposuction |
| Other plastic surgery group | Placebo comparator | Procedure: Other plastic surgery |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| LiposuctionA small, inconspicuous incision was made in the liposuction group to dislodge fat out of the body. | Procedure or surgery | liposuction group |
| Other plastic surgeryOther plastic surgery like blepharoplasty or keloid excision. | Procedure or surgery | Other plastic surgery group |
Primary outcome
menstrual irregularity
Time frame: three months
to detect any change in the menses during the following 3 months, post surgery
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 2 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Liposuction and Other plastic surgery in people with Menstrual Irregularity, run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
menstrual irregularity (time frame: three 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 2 Aug 2021.