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Endoscopic Assisted Latissimus Dorsi Musculocutaneous Flap for Breast Reconstruction

2 de julio de 2026 actualizado por: YOMNA SALAH MOHAMMAD SOLIMAN MAHMOUD, Kasr El Aini Hospital

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

15

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Cairo, Egipto
        • Kasr El Aini Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of patients with successful endoscopic-assisted latissimus dorsi musculocutaneous flap harvest and reconstruction without conversion to open technique
Periodo de tiempo: During surgery through 30 days postoperatively
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.
During surgery through 30 days postoperatively

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative pain
Periodo de tiempo: Up to 30 days after surgery
Postoperative pain was assessed using the Numeric Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Up to 30 days after surgery
Operative time
Periodo de tiempo: During the operation
Total operative time, measured in hours from skin incision to completion of wound closure.
During the operation
Donor-site morbidity
Periodo de tiempo: Up to 6 months after surgery
Donor-site morbidity was evaluated by recording postoperative complications including seroma, hematoma, wound infection, wound dehiscence, and other donor-site complications.
Up to 6 months after surgery
Donor-site scar length
Periodo de tiempo: up to 6 months after surgery
Final donor-site scar length was measured in centimeters.
up to 6 months after surgery
Patient satisfaction
Periodo de tiempo: One year after surgery
Patient-reported satisfaction with breast reconstruction and donor-site appearance was assessed using the BREAST-Q® Reconstruction Module.
One year after surgery
Utility of geometric scar prediction approximation
Periodo de tiempo: Preoperative planning compared with one-year postoperative scar assessment
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.
Preoperative planning compared with one-year postoperative scar assessment
Length of hospital stay
Periodo de tiempo: Up to 2 weeks after surgery
Length of postoperative hospital stay, measured in days from surgery until hospital discharge.
Up to 2 weeks after surgery
Time to drain removal
Periodo de tiempo: Up to 30 days after surgery
Time from surgery until removal of the surgical drain, measured in days.
Up to 30 days after surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Adel M Wilson, MD, Kasr El Aini Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

25 de enero de 2023

Finalización primaria (Actual)

15 de enero de 2024

Finalización del estudio (Actual)

30 de enero de 2026

Fechas de registro del estudio

Enviado por primera vez

27 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de julio de 2026

Publicado por primera vez (Actual)

8 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de julio de 2026

Última verificación

1 de septiembre de 2023

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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