The Impact of Use of a Retractor Sponge on Duration of Hospital Stay and Perioperative Complications in Patients With Colorectal Cancer Undergoing Laparoscopic Colorectal Surgery: the SPONGE Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Length of hospital stay
研究概览
简要总结
To achieve an adequate visual working field during laparoscopic colorectal surgery without disturbance of the small intestine, patients are positioned in Trendelenburg position. This position results in hemodynamic changes which may increase the risk of cardiopulmonary complications and prolonged hospital stay. Recently, an intraoperative retractor sponge was introduced as alternative for the Trendelenburg position during laparoscopic surgery.
详细描述
Objective: To study the impact of use of an intraoperative retractor sponge on duration of hospital stay and risk of perioperative complications in patients undergoing laparoscopic surgery for colorectal cancer.
Study design: Randomized controlled trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmRCT) design (clinicaltrials.gov NCT02070146).
Study population: Patients with colorectal cancer who undergo laparoscopic sigmoid of rectal resection, and who have given informed consent to be offered experimental interventions within the prospective cohort. Patient who require open surgery or patients with benign colorectal diseases are excluded for this study.
Intervention: Intraoperative use of the retractor sponge versus usual care, i.e. the Trendelenburg position.
Main study parameters/endpoints: The primary endpoint is hospital stay. Secondary objectives are operation time, blood-loss, fluid balance, body temperature, oxygen therapy and postoperative complications.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed distal colon (sigmoid) or rectal cancer,
- •planned for elective laparoscopic colorectal surgery,
- •performance status WHO 0-2
- •broad consent for randomization within ProspectIve data coLlection initiative on ColoRectal Cancer (PLCRC) cohort
排除标准
- •patients planned for open colorectal surgery or emergency colorectal surgery
- •patients with inadequate understanding of the Dutch language in speech and/or writing.
研究组 & 干预措施
sponge-assisted surgery group
Patients offered surgery with use of the retractor sponge
干预措施: Endoractor® (Device)
Control group
Patients receiving standard care, i.e. surgery in Trendelenburg position
结局指标
主要结局
Length of hospital stay
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Discharge is based on a checklist
次要结局
- Postoperative oxygen therapy(Baseline)
- Operation time (minutes)(Intraoperative)
- Blood-loss (ml)(Intraoperative)
- Fluid balance (L)(Intraoperative)
- Postoperative body temperature(Baseline)
- Postoperative complications(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
研究者
dr. A.B. Smits
MD PhD
St. Antonius Hospital