- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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).
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
California
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Sacramento, California, 미국, 95817
- University of California Davis Cancer Center
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Group 1
Patients undergo standard mastectomy.
|
Patients undergo tumescent or standard mastectomy
|
Group 2
Patients undergo tumescent mastectomy.
|
Patients undergo tumescent or standard mastectomy
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Post-operative pain at 1 and at 7-10 days after mastectomy
기간: 7-10 days
|
7-10 days
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Number of acetaminophen/oxycodone tablets taken
기간: 7-10 days after surgery
|
7-10 days after surgery
|
Total time of operation from breast incision to completion of wound closure
기간: Day of surgery
|
Day of surgery
|
Time of operation from first incision to completion of both superior and inferior skin flaps
기간: Day of surgery
|
Day of surgery
|
Estimated blood loss
기간: Day of surgery
|
Day of surgery
|
Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours
기간: 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
기간: Up to 10 days after surgery
|
Up to 10 days after surgery
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Steve R. Martinez, MD, University of California, Davis
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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