- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04985591
The Effect of Liposuction on Menses: a Retrospective Study
July 22, 2021 updated by: Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
516
Phase
- Early Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: liposuction group
|
A small, inconspicuous incision was made in the liposuction group to dislodge fat out of the body.
|
Placebo Comparator: Other plastic surgery group
|
Other plastic surgery like blepharoplasty or keloid excision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
menstrual irregularity
Time Frame: three months
|
to detect any change in the menses during the following 3 months, post surgery
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2016
Primary Completion (Actual)
March 12, 2021
Study Completion (Actual)
March 12, 2021
Study Registration Dates
First Submitted
July 22, 2021
First Submitted That Met QC Criteria
July 22, 2021
First Posted (Actual)
August 2, 2021
Study Record Updates
Last Update Posted (Actual)
August 2, 2021
Last Update Submitted That Met QC Criteria
July 22, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SH9H-2019-T221-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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