The Effect of Liposuction on Menses: a Retrospective Study
Primary Purpose
Menstrual Irregularity
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Liposuction
Other plastic surgery
Sponsored by
About this trial
This is an interventional prevention trial for Menstrual Irregularity
Eligibility Criteria
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.
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Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
liposuction group
Other plastic surgery group
Arm Description
Outcomes
Primary Outcome Measures
menstrual irregularity
to detect any change in the menses during the following 3 months, post surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT04985591
First Posted
July 22, 2021
Last Updated
July 22, 2021
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04985591
Brief Title
The Effect of Liposuction on Menses: a Retrospective Study
Official Title
The Effect of Liposuction on Menses: a Retrospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 14, 2016 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Irregularity
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
516 (Actual)
8. Arms, Groups, and Interventions
Arm Title
liposuction group
Arm Type
Experimental
Arm Title
Other plastic surgery group
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Liposuction
Intervention Description
A small, inconspicuous incision was made in the liposuction group to dislodge fat out of the body.
Intervention Type
Procedure
Intervention Name(s)
Other plastic surgery
Intervention Description
Other plastic surgery like blepharoplasty or keloid excision.
Primary Outcome Measure Information:
Title
menstrual irregularity
Description
to detect any change in the menses during the following 3 months, post surgery
Time Frame
three months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
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12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Liposuction on Menses: a Retrospective Study
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