Delaying the Superficial Inferior Epigastric Artery (SIEA) Flap and Determining the Change in SIEA Diameter and Blood Flow

November 23, 2010 updated by: University Medical Centre Ljubljana

Delaying the Superficial Inferior Epigastric Artery (SIEA) Flap: A Solution to the Problem of the Small Caliber of the Donor Artery

The purpose of this study is to determine whether delaying the superficial inferior epigastric artery (SIEA) flap results in widening of diameter and enhancing of blood flow of its donor artery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

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

  • Slovenia
      • Maribor, Slovenia, 2000
        • University Medical Centre Maribor

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing surgery for lower extremities varicose veins

Exclusion Criteria:

  • patients who previously underwent operations of the lower abdomen (abdominoplasty and inguinal hernia repair)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SIEA,delay procedure,widening of diameter
Procedure: Delay procedure of SIEA flap.
Ligating the deep inferior epigastric artery ipsilaterally to the planned raising of the SIEA flap 2 weeks prior to the reconstructive procedure.

Collaborators and Investigators

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

Sponsor

University Medical Centre Ljubljana

Collaborators

University Medical Centre Maribor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 23, 2010

First Posted (Estimate)

November 24, 2010

Study Record Updates

Last Update Posted (Estimate)

November 24, 2010

Last Update Submitted That Met QC Criteria

November 23, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG-2010

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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