Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction

NCT03106233 | Completed

• 1 other identifier: METC 14-5-095
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast reconstruction; Perforator flap; Microsurgery

Outcome Measures

Primary Outcomes (1)

• Recipient- and donor-site complications

  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.

  Through study completion up to an average of 12 months post-operatively

Secondary Outcomes (1)

• Flap re-explorations

  Through study completion up to an average of 12 months post-operatively

Study Arms (1)

LTP flap breast reconstruction

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.

Procedure: LTP flap

Interventions

LTP flap PROCEDURE

A flap is harvested from the upper lateral thigh region based on septocutaneous perforators located in the posterior septum between the tensor fascia latae and gluteus medius muscles.

Also known as: Lateral thigh perforator flap, Septocutaneous tensor fasciae latae (sc-TFL) flap

LTP flap breast reconstruction

Eligibility Criteria

• Gender Eligibility Details: Only female participants
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All female patients who opted for autologous breast reconstruction but who required an alternate flap than the deep inferior epigastric artery perforator (DIEP) flap.

You may qualify if:

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

You may not qualify if:

• Pre-operative imaging showing no suitable perforators

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Flaps

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgically-Created Structures; Equipment and Supplies

Study Officials

• Stefania Tuinder, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: April 10, 2017
• Study Start: September 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

NL (1)