Superomedial Pedicle Versus Inferior Pedicle Techniques in Wise Pattern Reduction Mammaplasty :A Comparison Study

November 21, 2020 updated by: Rami Ali Abdelkareem Eleiba, Kafrelsheikh University
A comparison study between superomedial and Inferior pedicle techniques in wise pattern reduction mammaplasty

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To compare complications of both techniques in wise pattern reduction mammaplasty and to correlate between complications and patient mediated factors

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Kafr Ash Shaykh, Egypt
        • Recruiting
        • Kafr Elsheikh University Hospital
        • Contact:
          • Rami Ali Abdelkareem Eleiba, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

-

Exclusion Criteria:

  • previous extensive breast surgery Breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Wise pattern reduction mammaplasty using Inferior pedicle
Procedure: Reduction mammaplasty
Breast reduction surgery
Other Names:
  • Superomedial pedicle versus Inferior pedicle techniques in wise pattern reduction mammaplasty
Active Comparator: Wise pattern reduction mammaplasty using superomedial pedicle
Procedure: Reduction mammaplasty
Breast reduction surgery
Other Names:
  • Superomedial pedicle versus Inferior pedicle techniques in wise pattern reduction mammaplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare complications of both techniques including nipple areola complex necrosis
Time Frame: 30 days postoperative
Complications include NAC necrosis and other minor complications including wound dehiscence and seroma or hematoma
30 days postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To correlate between complications and patient mediated factors
Time Frame: 30 days postoperative
Patient mediated factors including age, BMI, preoperative hb, suprasternal notch to nipple distance
30 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Investigators

  • Study Director: Safwat Adel hegazy, MD, Kafr elsheikh university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2020

Primary Completion (Anticipated)

January 20, 2021

Study Completion (Anticipated)

January 20, 2021

Study Registration Dates

First Submitted

November 21, 2020

First Submitted That Met QC Criteria

November 21, 2020

First Posted (Actual)

November 27, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 21, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Reduction mammaplasty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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