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Endoscopic Assisted Latissimus Dorsi Musculocutaneous Flap for Breast Reconstruction

2. Juli 2026 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

15

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Cairo, Ägypten
        • Kasr El Aini Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of patients with successful endoscopic-assisted latissimus dorsi musculocutaneous flap harvest and reconstruction without conversion to open technique
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Postoperative pain
Zeitfenster: 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
Zeitfenster: During the operation
Total operative time, measured in hours from skin incision to completion of wound closure.
During the operation
Donor-site morbidity
Zeitfenster: 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
Zeitfenster: up to 6 months after surgery
Final donor-site scar length was measured in centimeters.
up to 6 months after surgery
Patient satisfaction
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 30 days after surgery
Time from surgery until removal of the surgical drain, measured in days.
Up to 30 days after surgery

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Adel M Wilson, MD, Kasr El Aini Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

25. Januar 2023

Primärer Abschluss (Tatsächlich)

15. Januar 2024

Studienabschluss (Tatsächlich)

30. Januar 2026

Studienanmeldedaten

Zuerst eingereicht

27. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juli 2026

Zuerst gepostet (Tatsächlich)

8. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2026

Zuletzt verifiziert

1. September 2023

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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