A Randomized Clinical Trial Comparing Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Change in objective isokinetic abdominal strength
研究概览
简要总结
The Deep Inferior Epigastric Perforator flap (DIEP) is the current standard of care in breast reconstruction. The newer Superficial Inferior Epigastric Artery flap (SIEA) is felt to be an improvement as it does not damage the abdominal wall. The SIEA unfortunately has smaller vessels which put the flap at a higher risk of developing flap loss and fat necrosis. The uncertainty regarding the tradeoffs inherent in the choice of procedure has not been resolved. As such the investigators aim to perform a randomized single blinded trial to evaluate the abdominal and breast related morbidity associated with DIEP and SIEA flaps.
详细描述
A blinded, randomized, prospective clinical trial is being performed involving Manitoban women over 18 years undergoing unilateral or bilateral breast reconstruction. Women were originally randomized 50/50 to either the DIEP or SIEA group. Due to only about 60-70% of patients randomized to the SIEA group actually receiving the SIEA procedure, the weight of the randomization has now been changed to 70/30 (SIEA/DIEP) for the remainder of the study (approx. 40/110 recruited patients waiting for their OR). Objective isokinetic abdominal strength testing is being done pre-operatively and 3, 6 and 12 months post-operatively. A self-administered validated abdominal wall and breast outcome questionnaire (Breast-Q) is also given preoperatively and at 3 and 12 months postoperatively in . Secondary outcomes measured include: fat necrosis, abdominal wound breakdown, flap loss and seroma rate. Fat necrosis is detected using ultrasonography. Abdominal wound breakdown is measured using calipers. Seroma rates are tabulated and drainage volumes measured. Statistical analyses include a combination of parametric and non-parametric tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female subject older than 18
- •with satisfactory abdominal tissue for DIEP and SIEA flap reconstruction
- •fluent in English
排除标准
- •reconstruction planned using latissimus dorsi flap, gluteal artery perforator flap or tissue expansion
- •suffer from neurological back problems
- •suffer form inguinal hernias
研究组 & 干预措施
DIEP flap group
The standard of care for the patient population is the DIEP or SIEA flap breast reconstruction. Currently the single operating surgeon in the study will always try to perform a SIEA flap reconstruction. If the anatomy does not allow it he will convert to a DIEP flap. The majority of breast surgeons in North America will generally perform a DIEP flap initially. The proposed study does not alter the standard of care received.
干预措施: DIEP flap breast reconstruction (Procedure)
SIEA flap group
The standard of care for the patient population is the DIEP or SIEA flap breast reconstruction. Currently the single operating surgeon in the study will always try to perform a SIEA flap reconstruction. If the anatomy does not allow it he will convert to a DIEP flap. The majority of breast surgeons in North America will generally perform a DIEP flap initially. The proposed study does not alter the standard of care received.
干预措施: SIEA flap breast reconstruction (Procedure)
结局指标
主要结局
Change in objective isokinetic abdominal strength
时间窗: pre-operative (baseline), 3, 6 and 12 months post-operative
Strength of the abdominal muscles and the back extensors is being objectively measured by isokinetic strength testing on an isokinetic dynamometer (Biodex System III with dual position back extension/flexion attachment). The abdominal strength testing is being performed pre-operatively and at 3, 6 and 12 months post-op. Objective measurements are used to address the strength of the rectus abdominus muscle and all data is collected by personnel at PanAn Clinic who have been trained in the required techniques. The technician performing the assessments is blinded to the type of breast reconstruction that has been performed.
次要结局
- Breast-Q questionnaire(pre-operative (baseline) and 3 and 12 months post-operative)
- Seroma Rate and Drainage Volumes(1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op)
- Fat Necrosis(3 and 6 months post-operative)
- Flap Loss(1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op)
- Abdominal Wound Breakdown(1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op)
- Clinical Abdominal Examination(1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op)
- Intra-Operative Outcomes:(Intra-operative)