Clinical trial · Observational
Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer
Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique
NCT00859157CI-TRIAL-00028203completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: New surgery techniques may lessen pain after breast surgery. It is not yet known whether tumescent mastectomy or standard mastectomy results in less pain in women with breast cancer. PURPOSE: This clinical trial is studying pain after tumescent mastectomy compared with pain after standard mastectomy in women with stage I, stage II, or stage III breast cancer.
Conditions
Conditions (3)
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 |
| Pain | — | UNRESOLVED | — |
| Perioperative/Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- Patients undergo standard mastectomy.
- interventionNames
- Procedure: therapeutic conventional surgery
- label
- Group 2
- description
- Patients undergo tumescent mastectomy.
- interventionNames
- Procedure: therapeutic conventional surgery
Primary outcomes (1)
- measure
- Post-operative pain at 1 and at 7-10 days after mastectomy
- timeFrame
- 7-10 days
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Invasive (ductal or lobular) breast cancer * In situ (ductal) breast cancer * Stage 0-III disease * Localized disease * Candidate for curative mastectomy and selected mastectomy or modified radical mastectomy for surgical option of treatment at the University of California Davis Medical Center * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * WBC ≥ 1,500/mm\^3 * Platelet count ≥ 90,000/mm\^3 * PT/PTT ≤ upper limit of normal (ULN) * Creatinine ≤ 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * No NYHA cardiac disease class III-IV * Cancer survivors must have undergone potentially curative therapy for all prior malignancies with no evidence of prior malignancy within the last 5 years, except for effectively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix treated by surgery alone, or lobular carcinoma in situ of the breast treated by surgery alone * Body Mass Index ≤ 40 PRIOR CONCURRENT THERAPY: * No prior major breast surgery, including breast augmentation or reduction surgery * No preoperative chemotherapy or radiotherapy * No concurrent immediate breast reconstruction * No concurrent bilateral mastectomy * No concurrent narcotic pain medication
References
Publications (0)
Data not yet available
No reference posted for this study.