Clinical trial · Interventional
The Use of a High-frequency Ultrasonic Knife in Breast Cancer Surgery
Randomized Controlled Study of Benefits of Ultrasonic Knife in Breast Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Lymphatic stasis and seroma formation are common complications of axillary lymphadenectomy in breast cancer surgery. The investigators aim is to test the hypothesis that the use of an ultrasonic knife for axillary dissection reduces the total amount and duration of persistent drainage and length of hospital stay. Method: The investigators have conducted a randomized trial on 94 patients (1 male, 93 females, mean age 64.7 years) who presented to the investigators unit with operable breast carcinoma. Patients in group A (38 cases) were operated on using exclusively the ultrasonic knife. Patients in group B (56 cases) were operated on using the conventional diathermy knife.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional diarthermy knife | Procedure | — | UNRESOLVED |
| ultrasonic knife (Ultracision®, Ethicon Endo Surgery) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Patients were operated using an ultrasonic knife (Ultracision®, Ethicon Endo Surgery)
- interventionNames
- Procedure: ultrasonic knife (Ultracision®, Ethicon Endo Surgery)
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Patients were operated using a conventional diarthermy knife
- interventionNames
- Procedure: conventional diarthermy knife
Primary outcomes (1)
- measure
- Drainage Volume
- timeFrame
- discharge day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 36 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Operable breast cancer Exclusion Criteria: * Inoperable breast cancer * BMI \> 25 * Neoadiuvant radioterapy * Carcinomastitis * Previous phlebitis of omolateral arm * Collagen disease
References
Publications (0)
Data not yet available