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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
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Menstrual Irregularity

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    July 22, 2021
    Last Updated
    July 22, 2021
    Sponsor
    Shanghai Jiao Tong University School of Medicine
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    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. -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effect of Liposuction on Menses: a Retrospective Study

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