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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04985591
Other study ID # SH9H-2019-T221-2
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 14, 2016
Est. completion date March 12, 2021

Study information

Verified date July 2021
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 516
Est. completion date March 12, 2021
Est. primary completion date March 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Liposuction
A small, inconspicuous incision was made in the liposuction group to dislodge fat out of the body.
Other plastic surgery
Other plastic surgery like blepharoplasty or keloid excision.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary menstrual irregularity to detect any change in the menses during the following 3 months, post surgery three months
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