Randomized Controlled Trial to Evaluate the Effect of a Retractor Sponge in Postoperative Hospital Stay in Laparoscopic Colorectal Surgery in Patients With Malignancy
试验速览
- 阶段
- 不适用
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Postoperative hospital stay (days)
研究概览
简要总结
Laparoscopic surgery of the distal colon and rectum requires surgery with an appropriate field of view. A commonly used technique to create a clear exposure is the steep Trendelenburg position in which the patient is positioned in an angle of 15 to 40 degrees with the head down using the effect of gravity to retract the small intestine. This method is associated with haemostatic changes caused by the cranial shift of abdominal organs and blood. Recently, a cellulose compressed sponge was developed as intraoperative retractor, with the aim to keep the small intestines aside while the patient remains in a horizontal position. The safety of the sponge is secured with CE marking. The retractor sponge ensures a clear surgical field and potentially prevents haemostatic instability by avoiding Trendelenburg position. A pilot study in the St Antonius Hospital Nieuwegein has shown that use of the sponge might be associated with shorter hospital stay.
详细描述
Objective: We study the efficacy of the retractor sponge in laparoscopic colorectal surgery to reduce hospital stay in patients operated for a malignancy. Secondary objectives are duration of surgery, blood-loss, use of diuretics as volume therapy (during surgery as wells as during total hospital stay), postoperative hypoxemia and peri- and postoperative complications.
Study design: Randomized controlled trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmRCT) design.
Study population: Patients with colorectal cancer who undergo laparoscopic surgery, and who have given informed consent to be offered experimental interventions within the PICNIC project. 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 length of hospital stay. Secondary endpoints are duration of surgery, blood-loss, use of diuretics (during surgery as wells as during total hospital stay), postoperative hypoxemia and peri- and postoperative surgical, pulmonary and cardiac 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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant in the PICNIC project (METC 12-510)
- •Informed consent obtained for being offered experimental interventions within the PICNIC project
- •Informed consent obtained for questionnaires on patient reported outcomes within the PICNIC project
- •Planned for laparoscopic surgery of distal colorectal cancer in St. Antonius Hospital
排除标准
- •Planned for open colorectal surgery
- •Surgery for benign colorectal diseases
- •Emergency colorectal surgery
- •Inadequate understanding of the Dutch language in speech and/or writing
研究组 & 干预措施
Control group
Patients receiving standard care: surgery in Trendelenburg position
Sponge group
Patients offered surgery with the retractor sponge
干预措施: Sponge (Device)
结局指标
主要结局
Postoperative hospital stay (days)
时间窗: Up to 4 weeks
Based on a discharge checklist
次要结局
- Diuretics peroperative and postoperative(Up to 4 weeks (during hospital stay))
- Postoperative hypoxemia(Up to 1 week)
- Operation time(Up to 4 hours)
- Peri- and postoperative surgical complications(Up to 4 weeks)
- Pulmonary complications.(Up to 4 weeks)
- Cardiac complications(Up to 4 weeks)
- Blood-loss peroperative(During surgery time)
研究者
dr. A.B. Smits
Dr. A.M. Smits
St. Antonius Hospital