Trials / Completed
CompletedNCT05663112
Is Breast Massage Necessary to Find Sentinel Lymph Node?
Is Breast Massage Necessary to Find Sentinel Lymph Node After Isosulfan Blue Injection in Patients With Breast Cancer? A Prospective Randomized Study.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- Celal Bayar University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Sentinel lymph node biopsy is important for staging in patients with breast cancer and changes the way of surgery. One of the most commonly used methods to find the sentinel lymph node during surgery is to apply blue dye around the areola and then search for the sentinel lymph node. Breast massage is recommended following administration of the blue dye. However, the necessity of this massage is controversial. In this study, investigators will try to find out whether massage of the breast after blue dye injection has any positive effect on finding the sentinel lymph node.
Detailed description
This research is a prospective randomized study. Patients will be randomized by number-drawing method. Patients with BMI\>30 and age\>65 will be equally distributed to the experimental and active comparator arms. Under general anesthesia patients will be injected with 5 ml of isosulfan blue into the subareolar region. In one group, breast massage will be applied for 5 minutes. In the other group no massage will be applied. Surgical team will wait for a duration of 5 minutes for the self distribution of the blue dye.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Sentinel lymph node biopsy | Sentinel lymph node biopsy will be performed. |
| PROCEDURE | Breast massage | Breast massage will be performed for a duration of 5 minutes. |
| PROCEDURE | Blue dye injection | Isosulfan blue dye will be injected in the subareolar region of the breast |
Timeline
- Start date
- 2021-12-06
- Primary completion
- 2023-07-06
- Completion
- 2023-07-06
- First posted
- 2022-12-23
- Last updated
- 2023-09-25
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT05663112. Inclusion in this directory is not an endorsement.