NCT03669679

Brief Summary

The aim of this study is to evaluate Superomedial pedicle and Inferior pedicle techniques in breast reduction for Egyptian females and compare between both pedicles regarding cosmetic outcomes, possible complications, patient satisfaction and time of operation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
completed

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

April 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 12, 2018

Last Update Submit

September 12, 2018

Conditions

Breast Hypertrophy

Keywords

breast reductionmammaplastybreast-qpatient satisfactionpatient reported outcome measuressuperomedial pedicleinferior pedicle

Outcome Measures

Primary Outcomes (6)

  • Patient satisfaction

    evaluation of patient satisfaction pre/post-operatively using Arabic translated valid version of Breast-Q Reduction/Mastopexy Module (version 1)

    6 months

  • Blood loss

    estimation of hemoglobin level deficit by evaluating hemoglobin level 24 hours post-operatively

    24 hours

  • Acute Complications

    monitoring for the incidence of nipple \& areola congestion/ischemia, hematoma, seroma, infection, wound dehisence or skin flaps congestion/ischemia

    2 weeks

  • cosmetic outcomes

    evaluation of breast symmetry, contour, projection, postoperative scars and shape of nipple \& areola using standard photographs (anteroposterior, lateral and oblique views) by twoplastic surgery experts

    6 months

  • Breast Measurements

    * evaluation of breast vertical meridian and nipple to infra-mammary fold pre/post-operatively distance using tape measure * evaluation of breast degree of ptosis using Regnault's classification

    6 months

  • Duration of the procedure

    estimation of the duration of the surgery from sterilization until application of the dressing

    6 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

participants undergoing superomedial pedicle breast reduction "Hall-Findlay technique"

Procedure: Breast reduction

Group B

ACTIVE COMPARATOR

participants undergoing inferior pedicle breast reduction "Robbins technique"

Procedure: Breast reduction

Interventions

Breast reductionPROCEDURE

breast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique

Group AGroup B

Eligibility Criteria

Age22 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Bilateral breast hypertrophy

You may not qualify if:

  • Congenital breast anomalies.
  • Pregnant, lactating or smoker patient.
  • Previous breast reductions.
  • Co-morbid diseases e.g. diabetes , liver cirrhosis or thyroid disorders.
  • Body dysmorphic disorder
  • Patients on long term medications e.g. immunosuppressive drugs, steroids or cytotoxic drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Antony AK. Reply: A matched cohort study of superomedial pedicle vertical scar breast reduction (100 breasts) and traditional inferior pedicle wise-pattern reduction (100 breasts): an outcomes study over 3 years. Plast Reconstr Surg. 2014 Jun;133(6):885e-887e. doi: 10.1097/PRS.0000000000000210. No abstract available.

    PMID: 24867750BACKGROUND

  • Ramon Y, Sharony Z, Moscona RA, Ullmann Y, Peled IJ. Evaluation and comparison of aesthetic results and patient satisfaction with bilateral breast reduction using the inferior pedicle and McKissock's vertical bipedicle dermal flap techniques. Plast Reconstr Surg. 2000 Aug;106(2):289-95; discussion 295-7. doi: 10.1097/00006534-200008000-00006.

    PMID: 10946926BACKGROUND

  • Cabral IV, da Silva Garcia E, Sobrinho RN, Pinto NLL, Juliano Y, Veiga-Filho J, Ferreira LM, Veiga DF. Use of the BREAST-Q Survey in the Prospective Evaluation of Reduction Mammaplasty Outcomes. Aesthetic Plast Surg. 2018 Apr;42(2):388-395. doi: 10.1007/s00266-017-1009-6. Epub 2017 Nov 9.

    PMID: 29124379BACKGROUND

MeSH Terms

Conditions

GigantomastiaPatient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

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
Assistant Lecturer

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 13, 2018

Study Start

April 1, 2016

Primary Completion

March 30, 2018

Study Completion

May 30, 2018

Last Updated

September 14, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share