- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07691294
Endoscopic Assisted Latissimus Dorsi Musculocutaneous Flap for Breast Reconstruction
This prospective single-arm case series evaluates the feasibility, safety, and clinical outcomes of endoscopic-assisted latissimus dorsi musculocutaneous flap harvest for breast reconstruction. The study includes women with post-oncologic or post-burn breast deformities requiring autologous tissue reconstruction with a skin paddle measuring 6 cm or less in its greatest dimension.
The primary objective is to assess the feasibility of minimally invasive flap harvest while preserving reconstructive effectiveness. Secondary outcomes include flap viability, operative time, postoperative pain, drain duration, donor-site morbidity, scar quality, complications, and patient satisfaction. Patients are followed for one year after surgery, with clinical assessment and patient-reported outcome measures used to evaluate reconstructive and aesthetic results.
Study Overview
Status
Intervention / Treatment
Detailed Description
The latissimus dorsi (LD) musculocutaneous flap is a well-established option for breast reconstruction because of its reliable vascular anatomy and versatility. However, conventional flap harvest requires a long dorsal incision that may result in visible scarring, postoperative pain, seroma formation, and donor-site morbidity. Endoscopic-assisted harvest has been developed to minimize donor-site scarring while preserving the advantages of the conventional technique. Although endoscopic harvest of the muscle-only flap has been increasingly reported, evidence regarding endoscopic-assisted harvest of the musculocutaneous latissimus dorsi flap remains limited because inclusion of a skin paddle presents additional technical challenges.
This prospective case series was conducted at Kasr Al Ainy Hospital, Cairo University, to evaluate the feasibility, safety, and clinical outcomes of endoscopic-assisted latissimus dorsi musculocutaneous flap harvest in women requiring breast reconstruction following breast cancer treatment or burn deformity. Eligible patients required autologous reconstruction using a musculocutaneous flap with a skin paddle measuring no more than 6 cm in its greatest dimension and had an intact latissimus dorsi muscle and thoracodorsal vascular pedicle.
All procedures were performed under general anesthesia using an endoscopic-assisted technique through a limited donor-site incision. The flap was harvested under endoscopic visualization while preserving the thoracodorsal vascular pedicle, followed by transfer of the flap to the breast defect. Standard postoperative management and follow-up were performed for one year.
Outcome measures include flap viability, operative time, postoperative pain, drain output and duration, donor-site and recipient-site complications, scar quality assessed using the Vancouver Scar Scale, and patient-reported satisfaction measured using the BREAST-Q questionnaire. The study aims to determine whether endoscopic-assisted harvest of the latissimus dorsi musculocutaneous flap provides reliable breast reconstruction with reduced donor-site morbidity and improved cosmetic outcomes compared with those historically reported for conventional open harvest.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Kasr El Aini Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female patients aged 18 to 65 years.
- Patients with post-oncologic or post-burn breast deformities requiring autologous breast reconstruction.
- Patients requiring reconstruction with a latissimus dorsi musculocutaneous flap incorporating a skin paddle measuring ≤6 cm in its greatest dimension.
- Defects considered unsuitable for correction with local tissue rearrangement.
- Intact latissimus dorsi muscle and thoracodorsal vascular pedicle.
- Ability to provide written informed consent and comply with the study follow-up schedule.
Exclusion Criteria:
- Age younger than 18 years or older than 65 years.
- Body mass index (BMI) >35 kg/m².
- Uncontrolled medical comorbidities or immunosuppressive conditions.
- Absence of a skin defect requiring reconstruction.
- Cutaneous defects requiring a skin paddle >6 cm in its greatest dimension.
- Inadequate oncologic control or evidence of active disease.
- Ongoing adjuvant chemotherapy or radiotherapy at the time of reconstruction.
- Previous thoracic surgery or trauma compromising the latissimus dorsi muscle or thoracodorsal vascular pedicle.
- Inability or unwillingness to comply with study follow-up.
Study Plan
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 |
|---|---|
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Experimental: Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap Reconstruction
Participants underwent breast reconstruction using an endoscopic-assisted latissimus dorsi musculocutaneous flap harvested through a limited donor-site incision.
The procedure was performed to reconstruct post-oncologic or post-burn breast deformities while minimizing donor-site scarring and morbidity.
All participants received the same surgical intervention and were followed prospectively to evaluate surgical, aesthetic, and patient-reported outcomes.
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Participants underwent breast reconstruction using an endoscopic-assisted latissimus dorsi musculocutaneous flap harvested through a limited donor-site incision.
Endoscopic visualization was used to facilitate subcutaneous and submuscular dissection while preserving the thoracodorsal vascular pedicle and minimizing donor-site scar length.
After flap harvest, the musculocutaneous flap was transferred to the breast defect and inset according to the reconstructive requirements of each patient.
Standard postoperative care and follow-up were provided for all participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of patients with successful endoscopic-assisted latissimus dorsi musculocutaneous flap harvest and reconstruction without conversion to open technique
Time Frame: During surgery through 30 days postoperatively
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Success was defined as completion of endoscopic-assisted harvest and transfer of the latissimus dorsi musculocutaneous viable flap without conversion to a conventional open harvest.
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During surgery through 30 days postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain
Time Frame: Up to 30 days after surgery
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Postoperative pain was assessed using the Numeric Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
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Up to 30 days after surgery
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Operative time
Time Frame: During the operation
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Total operative time, measured in hours from skin incision to completion of wound closure.
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During the operation
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Donor-site morbidity
Time Frame: Up to 6 months after surgery
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Donor-site morbidity was evaluated by recording postoperative complications including seroma, hematoma, wound infection, wound dehiscence, and other donor-site complications.
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Up to 6 months after surgery
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Donor-site scar length
Time Frame: up to 6 months after surgery
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Final donor-site scar length was measured in centimeters.
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up to 6 months after surgery
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Patient satisfaction
Time Frame: One year after surgery
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Patient-reported satisfaction with breast reconstruction and donor-site appearance was assessed using the BREAST-Q® Reconstruction Module.
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One year after surgery
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Utility of geometric scar prediction approximation
Time Frame: Preoperative planning compared with one-year postoperative scar assessment
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The accuracy of the proposed geometric approximation for predicting final donor-site scar length was evaluated by comparing the estimated scar length with the measured postoperative scar length.
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Preoperative planning compared with one-year postoperative scar assessment
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Length of hospital stay
Time Frame: Up to 2 weeks after surgery
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Length of postoperative hospital stay, measured in days from surgery until hospital discharge.
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Up to 2 weeks after surgery
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Time to drain removal
Time Frame: Up to 30 days after surgery
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Time from surgery until removal of the surgical drain, measured in days.
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Up to 30 days after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adel M Wilson, MD, Kasr El Aini Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Endoscopic LD Flap
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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