Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by University of California, Davis.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of California, Davis
Collaborator:
Information provided by (Responsible Party):
Steve R. Martinez, MD, MAS, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00859157
First received: March 7, 2009
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Pain Perioperative/Postoperative Complications |
Procedure: therapeutic conventional surgery |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique |
Resource links provided by NLM:
Further study details as provided by University of California, Davis:
Primary Outcome Measures:
- Post-operative pain at 1 and at 7-10 days after mastectomy [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of acetaminophen/oxycodone tablets taken [ Time Frame: 7-10 days after surgery ] [ Designated as safety issue: No ]
- Total time of operation from breast incision to completion of wound closure [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
- Time of operation from first incision to completion of both superior and inferior skin flaps [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
- Estimated blood loss [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
- Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours [ Time Frame: 7-10 days after surgery ] [ Designated as safety issue: No ]
- Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively [ Time Frame: Up to 10 days after surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 74 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group 1
Patients undergo standard mastectomy.
|
Procedure: therapeutic conventional surgery
Patients undergo tumescent or standard mastectomy
|
|
Group 2
Patients undergo tumescent mastectomy.
|
Procedure: therapeutic conventional surgery
Patients undergo tumescent or standard mastectomy
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adult (age 18 or more) women with histologic diagnosis of stage 0, I, II, III breast cancer undergoing mastectomy.
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859157
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859157
Locations
| United States, California | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
Sponsors and Collaborators
University of California, Davis
Investigators
| Principal Investigator: | Steve R. Martinez, MD | University of California, Davis |
More Information
Additional Information:
No publications provided
| Responsible Party: | Steve R. Martinez, MD, MAS, Principal Investigator, University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00859157 History of Changes |
| Other Study ID Numbers: | CDR0000633754, UCD-CCSO001, 200816282-1 |
| Study First Received: | March 7, 2009 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Davis:
|
perioperative/postoperative complications pain ductal breast carcinoma in situ invasive ductal breast carcinoma invasive lobular breast carcinoma |
stage IA breast cancer stage IB breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Postoperative Complications Breast Diseases Neoplasms |
Neoplasms by Site Pathologic Processes Skin Diseases |
ClinicalTrials.gov processed this record on February 27, 2015