Comparison of Outcome Between Grisotti Flap Versus Reverse Mirror Grisotti Flap for Central Quadrant Breast Tumors (GRISOTTI FLAP)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- King Edward Medical University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Metastatic breast cancer
- Inflammatory breast cancer
- Patients not willing for post-operative radiotherapy
- High tumour-breast ratio
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Grisotti Flap
Grisotti flap will be used in this arm for the oncoplastic breast surgery.
|
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 .
|
|
Active Comparator: Reverse Mirror Grisotti flap
Reverse Mirror Grisotti flap will be used in this group for the oncoplastic breast surgery.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flap viability
Time Frame: 7 days
|
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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cosmetic outcome
Time Frame: 7 days
|
Cosmetic outcome will be explained with VAS (visual analogue scale) by the patient.
The scale will range from 0-10 with 0 being categorized as worst cosmetic outcome and 10 being categorized as best cosmetic outcome.
|
7 days
|
|
Seroma formation
Time Frame: 7 days
|
Seroma formation is the visible swelling at the operative site which will be confirmed and quantified by ultrasound on 7th post operative day with volume more than 20ml.
|
7 days
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- 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).
- 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
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- MayoLahore
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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