Comparison of Outcome Between Grisotti Flap Versus Reverse Mirror Grisotti Flap for Central Quadrant Breast Tumors

NCT07293052 | Active Not Recruiting DMC

• 1 other identifier: MayoLahore
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Breast conservation surgery is equivalent to mastectomy for early stage breast cancer patients. Central quadrant tumours can be treated with various oncoplastic techniques with a satisfactory aesthetic outcome and low morbidity. Grisotti flap and reverse mirror grisotti flap are the favourable viable surgical options for central quadrant breast tumours. our hypothesis is that there is a difference in the outcome between Grisotti versus Reverse Mirror Grisotti flap in centrally located breast cancers.

Conditions

Breast Cancer; Breast Reconstruction

Keywords

Central Quadrant Breast; Grisotti flap; Reverse Mirror Grisotti Flap

Outcome Measures

Primary Outcomes (1)

• Flap viability

  Absence of necrosis of new areola formed as seen clinically at 48 hours and 7th day postoperatively. Flap viability categories: A (None): No necrosis. B (Color Change): Color change suggesting impaired perfusion or ischemic injury. C (Partial Thickness): Partial thickness skin flap necrosis resulting in wound breakdown. D (Full Thickness): Full thickness skin flap necrosis.

  7 days

Secondary Outcomes (2)

• Cosmetic outcome

  7 days

• Seroma formation

  7 days

Study Arms (2)

Grisotti Flap

EXPERIMENTAL

Grisotti flap will be used in this arm for the oncoplastic breast surgery.

Procedure: Grisotti Flap

Reverse Mirror Grisotti flap

ACTIVE COMPARATOR

Reverse Mirror Grisotti flap will be used in this group for the oncoplastic breast surgery.

Procedure: Reverse Mirror Grisotti Flap

Interventions

Grisotti Flap PROCEDURE

The Grisotti flap is a local rotational flap used to reconstruct defects after removing a central breast cancer, often involving the nipple-areola complex (NAC). It uses tissue from the inferior pole of the breast to fill the central defect. The dermoglandular flap will be raised on infero-lateral perforators of intercostal arteries and will be rotated and advanced to fill the gap .

Grisotti Flap

Reverse Mirror Grisotti Flap PROCEDURE

The reverse-mirror version is a modification where the flap is flipped and reoriented, using the internal mammary vessels as the primary blood supply. The dermoglandular flap will be raised on the medial perforators of internal mammary artery and will be rotated and advanced to fill the defect.

Reverse Mirror Grisotti flap

Eligibility Criteria

• Age: 25 Years - 70 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed cases of breast cancer patients
• Gender: Females
• Age: 25-70 years
• T1 (\<2cm) and T2 (2-5cm) tumors with or without prior systemic therapy
• Tumor located in the NAC or located within 2 cm of the edge of the areola

You may not qualify if:

• Metastatic breast cancer
• Inflammatory breast cancer
• Patients not willing for post-operative radiotherapy
• High tumour-breast ratio

Sponsors & Collaborators

• Mayo Hospital Lahore: lead

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (5)

• Abdelkader AA, El-Fayoumi T, Roushdy A, Asal MF. Comparison between conventional and oncoplastic breast surgeries regarding resection margins and local recurrences in breast cancer: Retrospective study. The Egyptian Journal of Surgery. 2023; 7;42(4).

  RESULT

• Ozgul H, Celik O, Sakar B, Celik A, Oener OZ. Postoperative patient satisfaction and oncological Outcomes of Grisotti flap vs. Total mastectomy: A retrospective analysis

  RESULT

• Koppiker CB, Noor AU, Joshi S, Mishra R, Sivadasan P, Sheikh S., et al.Pushing the Boundaries for Centrally Located Breast Tumors in Oncoplastic Breast Surgery: A Single Centre Audit. medRxiv. 2024 ; 25:2024-11.

  RESULT

• Siddiqui R, Alsuwaidi SA, Irkorucu O, Mehmood MH, Khan NA. The Increasing Importance of Breast Cancer in the United Arab Emirates. Asia Pac J Clin Oncol. 2025 Nov 15. doi: 10.1111/ajco.70050. Online ahead of print.

  PMID: 41241761 RESULT

• Giaquinto AN, Sung H, Newman LA, Freedman RA, Smith RA, Star J, Jemal A, Siegel RL. Breast cancer statistics 2024. CA Cancer J Clin. 2024 Nov-Dec;74(6):477-495. doi: 10.3322/caac.21863. Epub 2024 Oct 1.

  PMID: 39352042 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 18, 2025
• Study Start: November 4, 2025
• Primary Completion: May 4, 2026
• Study Completion: May 4, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication
• Access Criteria: IPD could be provided after contacting with the principal investigator. Other researchers requiring information excluding personal data will be provided only for ethical and educational purposes.

Locations

PA (1)