Acquired Breast DeformityNCT07691294
Endoscopic Assisted Latissimus Dorsi Musculocutaneous Flap for Breast Reconstruction
A study testing Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap Harvest in people with Acquired Breast Deformity and Breast Cancer, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This prospective single-arm case series evaluates the feasibility, safety, and clinical outcomes of endoscopic-assisted latissimus dorsi musculocutaneous flap harvest for breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Acquired Breast Deformity, Breast Cancer, Post Burn Breast Deformities
- What is being tested?
- Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap Harvest
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2023to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap Harvest
- Keywords
- Breast reconstruction, Endoscopic-assisted surgery, Latissimus dorsi flap, Myocutaneous flap, Minimally invasive surgery, Donor-site morbidity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap HarvestProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap Reconstruction | Experimental | 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. Receives: Procedure: Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap Harvest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with successful endoscopic-assisted latissimus dorsi musculocutaneous flap harvest and reconstruction without conversion to open technique
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.
Measured: During surgery through 30 days postoperatively
Secondary outcomes (8)
Postoperative pain
Postoperative pain was assessed using the Numeric Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Up to 30 days after surgery
Operative time
Total operative time, measured in hours from skin incision to completion of wound closure.
Measured: During the operation
Donor-site morbidity
Donor-site morbidity was evaluated by recording postoperative complications including seroma, hematoma, wound infection, wound dehiscence, and other donor-site complications.
Measured: Up to 6 months after surgery
Donor-site scar length
Final donor-site scar length was measured in centimeters.
Measured: up to 6 months after surgery
Patient satisfaction
Patient-reported satisfaction with breast reconstruction and donor-site appearance was assessed using the BREAST-Q® Reconstruction Module.
Measured: One year after surgery
Utility of geometric scar prediction approximation
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.
Measured: Preoperative planning compared with one-year postoperative scar assessment
Length of hospital stay
Length of postoperative hospital stay, measured in days from surgery until hospital discharge.
Measured: Up to 2 weeks after surgery
Time to drain removal
Time from surgery until removal of the surgical drain, measured in days.
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start25 Jan 2023
- Primary completion15 Jan 2024
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Breast DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants undergo endoscopic-assisted latissimus dorsi musculocutaneous flap harvest for breast reconstruction. Outcomes are assessed prospectively without a comparison group.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YOMNA SALAH MOHAMMAD SOLIMAN MAHMOUD, Kasr El Aini Hospital
- Investigators
- Adel M Wilson, MD, Principal investigator, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691294
- Sponsor's protocol ID
- Endoscopic LD Flap
- Status last verified
- Sep 2023
- First submitted
- 27 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Assisted Latissimus Dorsi Musculocutaneous Flap for Breast Reconstruction
- ClinicalTrials.gov ID
- NCT07691294
- Acronym / sponsor ID
- Endoscopic LD Flap
- Keywords
- Breast reconstruction, Endoscopic-assisted surgery, Latissimus dorsi flap, Myocutaneous flap, Minimally invasive surgery, Donor-site morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants undergo endoscopic-assisted latissimus dorsi musculocutaneous flap harvest for breast reconstruction. Outcomes are assessed prospectively without a comparison group.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap Reconstruction | Experimental | Procedure: Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap HarvestParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap HarvestParticipants 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. | Procedure or surgery | Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap Reconstruction |
Primary outcome
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.
8 secondary outcomes
Postoperative pain
Time frame: Up to 30 days after surgery
Operative time
Time frame: During the operation
Donor-site morbidity
Time frame: Up to 6 months after surgery
Donor-site scar length
Time frame: up to 6 months after surgery
Patient satisfaction
Time frame: One year after surgery
Utility of geometric scar prediction approximation
Time frame: Preoperative planning compared with one-year postoperative scar assessment
Length of hospital stay
Time frame: Up to 2 weeks after surgery
Time to drain removal
Time frame: Up to 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adel M Wilson, MD principal investigator
Kasr El Aini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic-Assisted Latissimus Dorsi Musculocutaneous Flap Harvest in people with Acquired Breast Deformity and Breast Cancer, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.