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Endoscopic Assisted Latissimus Dorsi Musculocutaneous Flap for Breast Reconstruction

2026년 7월 2일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

15

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Cairo, 이집트
        • Kasr El Aini Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of patients with successful endoscopic-assisted latissimus dorsi musculocutaneous flap harvest and reconstruction without conversion to open technique
기간: 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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Adel M Wilson, MD, Kasr El Aini Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 1월 25일

기본 완료 (실제)

2024년 1월 15일

연구 완료 (실제)

2026년 1월 30일

연구 등록 날짜

최초 제출

2026년 6월 27일

QC 기준을 충족하는 최초 제출

2026년 7월 2일

처음 게시됨 (실제)

2026년 7월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 2일

마지막으로 확인됨

2023년 9월 1일

추가 정보

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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