Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: LTP flap

• Registration Number: NCT03106233
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The lateral thigh perforator (LTP) flap was previously introduced as an alternative flap for autologous breast reconstruction when the abdomen is not suitable as a donor site. In this prospective study all LTP flap breast reconstructions that have been performed since September 2012 are analyzed. In addition, the surgical refinements that were introduced over the years are reported.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Study First Submitted: 2017-02-09
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-03
• Last Update Submitted: 2017-04-03
• Study First Posted: 2017-04-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• Lateral thigh region suitable as a donor site
• Abdomen not suitable as donor site
• Informed consent

Exclusion Criteria

• Pre-operative imaging showing no suitable perforators

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LTP flap breast reconstruction	LTP flap	All consecutive patients who underwent LTP flap breast reconstructions (unilateral, bilateral or stacked unilateral) between September 2012 and November 2016 at three centers in Maastricht, the Netherlands, and New York and New Orleans, the United States, were included. Autologous breast reconstruction was performed by using the upper lateral thigh region as a donor site.

Primary Outcome Measures

Name	Time	Method
Recipient- and donor-site complications	Through study completion up to an average of 12 months post-operatively	Recipient site: Total flap loss, partial flap loss, venous congestion, infection, hematoma, seroma, fat necrosis and wound complications. Donor site: Infection, hematoma, seroma, fat necrosis, wound complications.

Secondary Outcome Measures

Name	Time	Method
Flap re-explorations	Through study completion up to an average of 12 months post-operatively	Total number of flaps that required a re-exploration because of arterial or venous insufficiency, hematoma or kinking of the pedicle.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands