NCT04985591

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
516

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2016

Longer than P75 for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

4.7 years

First QC Date

July 22, 2021

Last Update Submit

July 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • menstrual irregularity

    to detect any change in the menses during the following 3 months, post surgery

    three months

Study Arms (2)

liposuction group

EXPERIMENTAL
Procedure: Liposuction

Other plastic surgery group

PLACEBO COMPARATOR
Procedure: Other plastic surgery

Interventions

LiposuctionPROCEDURE

A small, inconspicuous incision was made in the liposuction group to dislodge fat out of the body.

liposuction group

Other plastic surgery like blepharoplasty or keloid excision.

Other plastic surgery group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Menstruation Disturbances

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2021

First Posted

August 2, 2021

Study Start

June 14, 2016

Primary Completion

March 12, 2021

Study Completion

March 12, 2021

Last Updated

August 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share