Reconstruction of Partial Mastectomy Defects With Pectoralis Myo-glandular Local Flap.

NCT04091958 | Unknown Phase 1

• 1 other identifier: R/19.08.578
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Increasing number of breast cancer patients are being treated with conservative surgery; without the need for mastectomy. The cosmetic sequel of breast conservative surgery can be unsatisfactory to the patient and may necessitate secondary surgery. The present study aims at improving the cosmetic outcome of breast conservative surgery. The defect remaining in the breast tissue after excision of the tumour will be filled with the underlying pectoralis major muscle. This pilot study will test the safety and efficacy of using the pectoralis major muscle for reconstructing a partial mastectomy defect. fifteen patients with early breast cancer scheduled for breast conservation will be recruited to this study.

Conditions

Breast Cancer

Keywords

Breast conserving surgery; Pectoralis major muscle

Outcome Measures

Primary Outcomes (2)

• The rate of major complications

  The rate of major complications related to surgery that necessitate further intervention.

  Six weeks after surgery.

• The score of early cosmetic outcome

  This is a categorical variable. The cosmetic score is reported according to the Harris method. In this method the overall cosmetic result is ranked as one of four scores. The maximum score is "Excellent" where the treated breast is identical to the other breast. Slight difference is scored as "Good". Marked difference without distortion is scored as " Fair". The least score is " Poor" where there is breast distortion.

  Six weeks after surgery.

Secondary Outcomes (1)

• The score of late cosmetic outcome

  12 Months after surgery.

Other Outcomes (1)

• The percentage of adequate resection

  Two weeks after surgery.

Study Arms (1)

Post-tumourectomy reconstruction with myo-glandular flap.

EXPERIMENTAL

Standard tumourectomy followed by reconstruction with myo-glandular flap.

Procedure: Pectoralis myo-glandular flap reconstruction.

Interventions

Pectoralis myo-glandular flap reconstruction. PROCEDURE

Tumorectomy with surgical margin will be evaluated with frozen-section examination. Reconstruction starts with mobilization of skin flaps. The sternal head of the pectoralis major muscle will be disconnected from its insertion at the humerus. The muscle fibers will be mobilized off the chest wall. The pectoralis major receives dual blood supply. The pectoral branches of the thoraco-acromial artery enter the superior part of the muscle and the perforator branches of the internal mammary artery enter the medial part of the muscle. According to the location of the defect in the breast, the muscle will be mobilized based on one vascular pedicle. The muscle flap may consist of all or some segmental fibres of the sternal head of the pectoralis major muscle. In all cases, the muscle flap connection to the overlying breast parenchyma is kept intact and the clavicular head of the pectoralis major muscle is undisturbed. Closure of the cavity in layers over suction drain will follow.

Post-tumourectomy reconstruction with myo-glandular flap.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with early breast cancer or phylloides tumor.
• Eligible for breast conservative surgery.
• Expected post-lumpectomy volume loss of 20-40% of breast volume.
• Tumor location in upper quadrants.
• Informed consent.

You may not qualify if:

• Patient refusal.
• Contraindication of breast conservative therapy:
• Pregnancy.
• Diffuse microcalcifications.
• Patient choice for mastectomy.
• Collagen / vascular disease.
• Multicentric tumor.
• Psychological co-morbidity.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Oncology Center

Al Mansurah, DK, 35516, Egypt

RECRUITING

Related Publications (3)

• Harris JR, Levene MB, Svensson G, Hellman S. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1979 Feb;5(2):257-61. doi: 10.1016/0360-3016(79)90729-6. No abstract available.

  PMID: 110740 BACKGROUND

• Tobin GR. Pectoralis major segmental anatomy and segmentally split pectoralis major flaps. Plast Reconstr Surg. 1985 Jun;75(6):814-24. doi: 10.1097/00006534-198506000-00009.

  PMID: 4001201 BACKGROUND

• Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.

  PMID: 12393820 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Osama Hussein, MD,PhD.FEBS

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osama Hussein, MD, PhD

CONTACT

+20 1099 8151 10; osamahussein@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: This is a cohort study.

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: August 24, 2019
• Primary Completion: January 30, 2021
• Study Completion: February 28, 2022
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

EG (1)