The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery: a Stepped Wedge Cluster Randomized Trial Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Textbook outcome
研究概览
简要总结
Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting technique, in which the skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. Main objective of this randomized stepped wedge study is to assess the impact of large scale implementation of the quilting technique in patients undergoing mastectomy and/or axillary lymph node dissection. This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. The hypothesis is that quilting is a simple and cost-effective technique to increase textbook outcome. Moreover, it is expected that patient comfort is enhanced by quilting.
详细描述
Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting technique, in which skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. However, implementation is lagging due to unknown side effects, increase in operation time and cost effectiveness. Main objective of this study is to assess the impact of large scale implementation of the quilting suture technique in patients undergoing mastectomy and/or axillary lymph node dissection (ALND).
The QUILT study is a stepped wedge design study performed among nine teaching hospitals in the Netherlands. The study consists of nine steps, with each step one hospital will implement the quilting suture technique. Allocation of the order of implementation will be randomization-based. Primary outcome is 'textbook outcome', i.e.no wound complications, no re-admission, re-operation or unscheduled visit to the outpatient clinic and use of analgesics is not increased postoperative. A total of 113 patients is required based on a sample size calculation.
This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. The hypothesis is that quilting is a simple technique to increase textbook outcome, without increasing health care consumption. Moreover, the expectation is that patient comfort is enhanced by quilting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Surgical technique is not blinded for surgeon and/or patients. An independent panel of four surgeons will blindly assess cosmetics.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all patients >18 years of age undergoing mastectomy and/or axillary lymph node dissection
- •be irrespective of the nature of the primary tumour: prophylactic, risk reducing, benign, in situ carcinoma and invasive primary or recurrent carcinoma will be eligible, irrespective of preoperative systemic therapy.
排除标准
- •patients who objected to participation (letter of objection)
- •mentally incompetent patients or otherwise unable to complete a questionnaire
- •immediate breast reconstruction
- •pregnancy
结局指标
主要结局
Textbook outcome
时间窗: 6 months
'Textbook outcome' (TO), a combination of outcome parameters reflecting an ideal surgical outcome. Measured 6 months post-operative, the patients postoperative course must comply with the following to meet the definition of TO: * no wound complications * no re-admissions in relation to primary surgery * no re-operation in relation to primary surgery, re-excisions in case of involved margins allowed * no unscheduled visit to the outpatient clinic (depending on the centre one or two postoperative visits are usually scheduled) * postoperative use of analgesics (6 months) is not increased compared to pre-operative
次要结局
- Bleeding complications(6 months)
- Duration of surgery(360 minutes)
- Shoulder function(6 months)
- All palpation-detected seromas(6 months)
- Clinical significant seroma(6 months)
- Surgical site infections(6 months)
- Length of hospital stay(6 months)
- Post-operative pain(6 months)
- Unscheduled visits to the outpatient clinic(6 months)
- Readmission to the hospital(6 months)
- Reoperation(6 months)
- Cosmetic outcome assessed by an independent panel(6 months)
- Wound healing problems(6 months)
- Patient reported satisfaction with breast(6 months)
研究者
Lotte van Zeelst
Executive investigator
Canisius-Wilhelmina Hospital