Comparison of two surgical techniques (Grisotti vs Wise pattern) for breast-conserving surgery in central breast cancer
| ISRCTN | ISRCTN16836500 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16836500 |
| Secondary identifying numbers | Cairo University REC Approval Code: MD-266-2023 |
- Submission date
- 20/05/2025
- Registration date
- 28/05/2025
- Last edited
- 28/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study looks at two different types of breast-conserving surgery used to treat women with breast cancer located near the nipple. These techniques aim to remove the cancer while preserving the appearance of the breast. The study compares the outcomes of the Grisotti technique and the Wise pattern technique to find out which provides better cancer clearance and cosmetic results.
Who can participate?
Women aged 35 to 75 years with centrally located, early-stage breast cancer who are suitable for breast-conserving surgery and have not had previous breast surgery or radiotherapy.
What does the study involve?
Participants were randomly assigned to receive either the Grisotti technique or the Wise pattern surgery. The results were assessed by examining whether the cancer was fully removed, if there were any complications, and how patients and surgeons rated the appearance of the breast after surgery.
What are the possible benefits and risks of participating?
All patients received standard breast cancer treatment. There may be improved understanding of which technique leads to better outcomes. Risks include standard surgical complications such as infection, seroma, or wound issues.
Where is the study run from?
Kasr Al-Ainy Teaching Hospital, Faculty of Medicine, Cairo University (Egypt)
When is the study starting and how long is it expected to run for?
March 2023 to November 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Ahmed Shafik Jr, ahmed.shafik@ngu.edu.eg, shafikahmed@me.com
Contact information
Public, Scientific, Principal Investigator
School of Medicine
New Giza University, Cairo
Alexandria Desert Road, Km 22
Cairo
12588
Egypt
 ORCID ID |
0009-0002-8035-066X |
|---|---|
| Phone | +20 (0)1099990561 |
| ahmed.shafik@ngu.edu.eg |
Study information
| Study design | Prospective single-center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Comparative outcomes of the Grisotti technique and its modifications in breast-conserving surgery: aesthetic and oncological implications |
| Study acronym | COG-Wise |
| Study objectives | The Wise pattern technique provides superior aesthetic outcomes compared to the Grisotti technique in centrally located breast cancer, without compromising oncological safety. |
| Ethics approval(s) |
Approved 10/09/2023, Research Ethics Committee, Faculty of Medicine, Cairo University (Kasr Al Ainy Street, Cairo, 11562, Egypt; +20 (0)223651351; dean@kasralainy.edu.eg), ref: MD-266-2023 |
| Health condition(s) or problem(s) studied | Centrally located breast cancer (early-stage, operable) |
| Intervention | Participants were randomised in a 1:1 ratio using sealed opaque envelopes. The randomisation process was managed by a person independent of patient enrollment, surgical procedures, and outcome assessments. Patients were randomly allocated to undergo one of two breast-conserving surgical techniques: 1. Grisotti flap technique 2. Wise pattern therapeutic reduction Both procedures aimed to achieve clear oncological margins with acceptable aesthetic outcomes. Both patient- and surgeon-reported outcomes were assessed over a 12-month follow-up. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Margin status (tumor-free vs involved), assessed by pathology examination immediately post-surgery |
| Secondary outcome measures | 1. Patient satisfaction measured using a 5-point Likert scale questionnaire at 3 and 12 months postoperatively 2. Surgeon-assessed aesthetic outcomes using a visual analog scale (VAS, 0–10) at 12 months postoperatively 3. Postoperative complications (seroma, infection, wound dehiscence) recorded clinically within 30 postoperative days 4. Tumor size and distance from the nipple-areola complex as documented in the pathology report at surgery |
| Overall study start date | 15/03/2023 |
| Completion date | 15/11/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 75 Years |
| Sex | Female |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Female patients aged 35–75 years 2. Histologically confirmed centrally located breast cancer (T1–T2) 3. Tumor located within 2 cm of the nipple-areola complex 4. Suitable for breast-conserving surgery 5. Provided written informed consent |
| Key exclusion criteria | 1. Non-central tumors (outside central quadrant) 2. Inflammatory breast cancer (T4d) 3. Metastatic disease 4. Multicentric tumors 5. Breast size smaller than cup size C 6. Prior breast surgery or irradiation |
| Date of first enrolment | 15/10/2023 |
| Date of final enrolment | 15/09/2024 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Cairo University
Kasr Al-Ainy Street
Cairo
11562
Egypt
Sponsor information
University/education
Kasr Al-Ainy Street
Faculty of Medicine
Cairo
11562
Egypt
| Phone | +20 (0)223651351 |
|---|---|
| dean@kasralainy.edu.eg | |
| Website | http://med.cu.edu.eg/ |
"ROR" |
https://ror.org/03q21mh05 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 17/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study will be submitted for peer-reviewed publication in an international surgical journal. Findings may also be presented at academic conferences focused on breast cancer surgery and oncoplastic techniques. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon reasonable request from the corresponding author Dr Ahmed Shafik Jr (ahmed.shafik@ngu.edu.eg, shafikahmed@me.com). Data shared will be de-identified and limited to variables relevant to the reported outcomes. Only aggregate data will be published in the manuscript. Individual-level data (e.g., patient satisfaction scores, surgeon ratings, complications) may be shared in an anonymized format upon request and subject to ethics approval. Consent was obtained from participants for the use of their data in research, but not for open publication of raw data. Therefore, data will not be posted in a public repository but may be shared for academic collaboration, following institutional data-sharing protocols. The data will be available from the time of publication and for up to 5 years. Requests will be considered on a case-by-case basis and must include a short data use proposal. No personally identifiable information will be released. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 28/05/2025 | No | No |
Additional files
Editorial Notes
21/05/2025: Study's existence confirmed by the Research Ethics Committee, Faculty of Medicine, Cairo University.
