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Completed

NCT Number: 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr El Aini Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap Harvest

Procedure

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Postoperative pain

    Time frame: 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).

  2. Operative time

    Time frame: During the operation

    Total operative time, measured in hours from skin incision to completion of wound closure.

  3. Donor-site morbidity

    Time frame: 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.

  4. Donor-site scar length

    Time frame: up to 6 months after surgery

    Final donor-site scar length was measured in centimeters.

  5. Patient satisfaction

    Time frame: One year after surgery

    Patient-reported satisfaction with breast reconstruction and donor-site appearance was assessed using the BREAST-Q® Reconstruction Module.

  6. Utility of geometric scar prediction approximation

    Time frame: 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.

  7. Length of hospital stay

    Time frame: Up to 2 weeks after surgery

    Length of postoperative hospital stay, measured in days from surgery until hospital discharge.

  8. Time to drain removal

    Time frame: Up to 30 days after surgery

    Time from surgery until removal of the surgical drain, measured in days.

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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