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CompletedNCT01247129Updated Nov 24, 2010

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

A Phase 2 interventional study of Delay procedure of SIEA flap. in Breast Neoplasms, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-11-24.

Sponsored by University Medical Centre Ljubljana · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Breast Neoplasms

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Keywords

  • Superficial inferior epigastric artery flap, delay phenomenon
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 26 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients undergoing surgery for lower extremities varicose veins

Exclusion criteria

Exclusion Criteria:

  • patients who previously underwent operations of the lower abdomen (abdominoplasty and inguinal hernia repair)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    SIEA,delay procedure,widening of diameter

    Procedure: Delay procedure of SIEA flap.

Interventions

  • ProcedureDelay 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.

06

Study locations

1 site
  • University Medical Centre Maribor
    Maribor, 2000, Slovenia
07

References and documents

Publications

  • Gregoric M, Flis V, Milotic F, Mrda B, Stirn B, Arnez ZM. Delaying the superficial inferior epigastric artery flap: a solution to the problem of the small calibre of the donor artery. J Plast Reconstr Aesthet Surg. 2011 Sep;64(9):1181-6. doi: 10.1016/j.bjps.2011.04.009. Epub 2011 May 10. PubMed 21561823 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01247129
Lead sponsor
University Medical Centre Ljubljana
Collaborators
University Medical Centre Maribor
First posted
Nov 24, 2010
Start date
Sep 2009
Primary completion
May 2010
Completion
Sep 2010
Last update
Nov 24, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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