- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00859157
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
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
Primary
- To compare post-operative pain after tumescent vs standard mastectomy in women with stage I-III breast cancer.
Secondary
- To compare the total time of operation from incision to completion of wound closure.
- To compare the time of operation from first incision to completion of skin flaps.
- To compare the total estimated blood loss.
- To compare the number of days the Jackson-Pratt drain is left in place under skin flaps with wound drainage > 30 mL/24 hours.
- To compare the incidence of wound complications such as skin necrosis, hematoma, cellulitis, abscess, and seroma between groups.
OUTLINE: Patients are grouped according to which surgeon provided their evaluation and treatment recommendations.
- Group 1: Patients undergo standard mastectomy.
- Group 2: Patients undergo tumescent mastectomy. All patients receive standardized post-operative pain management comprising morphine sulfate for analgesia or an equivalent dose of hydromorphone hydrochloride for 24 hours following surgery. Patients then receive 1-2 oral acetaminophen/oxycodone hydrochloride combination tablets (or a comparable amount of another narcotic/acetaminophen combination) every 6 hours as needed. Pain is assessed using the Short-form McGill Pain Questionnaire (SF-MPQ).
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
California
-
Sacramento, California, Förenta staterna, 95817
- University of California Davis Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Group 1
Patients undergo standard mastectomy.
|
Patients undergo tumescent or standard mastectomy
|
|
Group 2
Patients undergo tumescent mastectomy.
|
Patients undergo tumescent or standard mastectomy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Post-operative pain at 1 and at 7-10 days after mastectomy
Tidsram: 7-10 days
|
7-10 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Number of acetaminophen/oxycodone tablets taken
Tidsram: 7-10 days after surgery
|
7-10 days after surgery
|
|
Total time of operation from breast incision to completion of wound closure
Tidsram: Day of surgery
|
Day of surgery
|
|
Time of operation from first incision to completion of both superior and inferior skin flaps
Tidsram: Day of surgery
|
Day of surgery
|
|
Estimated blood loss
Tidsram: Day of surgery
|
Day of surgery
|
|
Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours
Tidsram: 7-10 days after surgery
|
7-10 days after surgery
|
|
Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively
Tidsram: Up to 10 days after surgery
|
Up to 10 days after surgery
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Steve R. Martinez, MD, University of California, Davis
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 246600
- UCD-CCSO001
- 200816282
- CDR0000633754 (Annan identifierare: UC Davis)
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