Delaying the Superficial Inferior Epigastric Artery (SIEA) Flap and Determining the Change in SIEA Diameter and Blood Flow
This study has been completed.
Sponsor:
University Medical Centre Ljubljana
Collaborator:
University Medical Centre Maribor
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01247129
First received: November 23, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Procedure: Delay procedure of SIEA flap. |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Delaying the Superficial Inferior Epigastric Artery (SIEA) Flap: A Solution to the Problem of the Small Caliber of the Donor Artery |
Resource links provided by NLM:
Further study details as provided by University Medical Centre Ljubljana:
| Enrollment: | 26 |
| Study Start Date: | September 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247129
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247129
Locations
| Slovenia | |
| University Medical Centre Maribor | |
| Maribor, Slovenia, 2000 | |
Sponsors and Collaborators
University Medical Centre Ljubljana
University Medical Centre Maribor
More Information
No publications provided by University Medical Centre Ljubljana
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Minja Gregorič, University Medical Centre Maribor |
| ClinicalTrials.gov Identifier: | NCT01247129 History of Changes |
| Other Study ID Numbers: | MG-2010 |
| Study First Received: | November 23, 2010 |
| Last Updated: | November 23, 2010 |
| Health Authority: | Slovenia: Ethics Committee |
Keywords provided by University Medical Centre Ljubljana:
|
Superficial inferior epigastric artery flap, delay phenomenon |
ClinicalTrials.gov processed this record on February 27, 2015