LaPAroscopic Low pRessure cOlorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Length of postoperative hospital stay
研究概览
简要总结
Laparoscopy by its mini-invasive character has revolutionized abdominal and colorectal surgery but certain limitations remains (post-operative pain due to pneumoperitoneum, pneumoperitoneum stability, visibility during bleeding, smoke evacuation). The medical device for continuous pressure insufflation during laparoscopic procedures Airseal® would allow the maintenance of pneumoperitoneum at a lower pressure. The stable low pressure (7mmHg) is described in the literature for 15 years as the best way to reduce scapular pain, but until the marketing of Airseal, working at 7mmHg was not possible because the space of work was not stable. Moreover, this device makes it possible to obtain a better vision because of the evacuation of the fumes potentially leading to a reduction in the operating time.
详细描述
This research focuses on a medical device that allows the surgeon to perform the surgical procedure at a lower pressure than usual.
The main objective of this study is to compare the duration of hospitalization of patients with laparoscopic colectomy at low pressure (5-7 mmHg) versus standard pressure (12-15 mmHg) It is a prospective randomized monocentric double blind study
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
- Double (Participant, Outcomes Assessor)
盲法说明
The study will be carried out:
- Blind patient: The patient will not know the group he belongs to, in order to minimize the bias related to the self-evaluation of postoperative pain
- Blind for the outpatient evaluator: the surgeon will blindly evaluate the primary endpoint: patient's discharge criteria. This "evaluator" surgeon will be different from the "operator" surgeon The blind will minimize the measurement bias.
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
- •Colonic resection (right or left) performed for benign or malignant pathology
- •Laparoscopic procedure
- •Informed consent signed
- •Social Insurance
排除标准
- •Laparotomy procedure
- •Associated resection (except appendectomy or liver biopsy
- •Emergency procedure
- •Pelvic sepsis
- •Pregnant or breast-feeding woman.
- •Persons deprived of liberty or under guardianship
- •Impossibility for compliance to follow-up
结局指标
主要结局
Length of postoperative hospital stay
时间窗: From surgery to the end of the hospitalization (max 30 days)
To determine the length of hospitalization
次要结局
- Rates of conversion(During surgery)
- Volume replacement (mL)(During surgery)
- Driving pressure (mmHg)(During surgery)
- Time before mobilization (Days before 1st time sitting and standing)(An average of 5 days after the surgery)
- Surgery time(During surgery)
- Appreciation of visual quality by surgeon(During surgery)
- Cardiac frequency (/ min)(During surgery)
- Use of analgesics(An average of 5 days after the surgery)
- Number of lymph nodes examed(During surgery)
- Blood pressure (mmHg)(During surgery)
- Oxygen saturation (%)(During surgery)
- Surgical and medical morbidity(From surgery until 30 days (max 45 days))
- Time before the passage of first gas (days)(An average of 5 days after the surgery)
- Partial pressure of mean expired of carbon dioxide (mmHg)(During surgery)
- Quality of cancer surgery(During surgery)
- Impact of the use of microlaparoscopic instruments(During surgery)
- Postoperative pain(2 hours, 4 hours, 8 hours and 24 hours after the surgery)
- Time before the passage of first stool (days)(An average of 5 days after the surgery)