NCT04646070

Brief Summary

A comparison study between superomedial and Inferior pedicle techniques in wise pattern reduction mammaplasty

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 21, 2020

Last Update Submit

November 21, 2020

Conditions

To Compare Complications of Both Techniques in Wise Pattern Reduction Mammaplasty and to Correlate Between Complications and Patient Mediated Factors

Outcome Measures

Primary Outcomes (1)

  • To compare complications of both techniques including nipple areola complex necrosis

    Complications include NAC necrosis and other minor complications including wound dehiscence and seroma or hematoma

    30 days postoperative

Secondary Outcomes (1)

  • To correlate between complications and patient mediated factors

    30 days postoperative

Study Arms (2)

Wise pattern reduction mammaplasty using Inferior pedicle

ACTIVE COMPARATOR

Wise pattern reduction mammaplasty using Inferior pedicle

Procedure: Reduction mammaplasty

Wise pattern reduction mammaplasty using superomedial pedicle

ACTIVE COMPARATOR
Procedure: Reduction mammaplasty

Interventions

Reduction mammaplastyPROCEDURE

Breast reduction surgery

Also known as: Superomedial pedicle versus Inferior pedicle techniques in wise pattern reduction mammaplasty
Wise pattern reduction mammaplasty using Inferior pedicleWise pattern reduction mammaplasty using superomedial pedicle

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHealthy female patients with macromastia
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • previous extensive breast surgery Breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, Egypt

RECRUITING

Study Officials

  • Safwat Adel hegazy, MD

    Kafr Elsheikh University

    STUDY DIRECTOR

Central Study Contacts

Rami Ali Abdelkareem Eleiba, Master

CONTACT

+2 01028835799Ramieleiba@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of plastic surgery

Study Record Dates

First Submitted

November 21, 2020

First Posted

November 27, 2020

Study Start

January 20, 2020

Primary Completion

January 20, 2021

Study Completion

January 20, 2021

Last Updated

November 27, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations

EG(1)