Low Impact Laparoscopy In Bariatric Surgery- A Monocentric Randomised Trial Comparing Low-Pressure Pneumoperitoneum Plus Microsurgery Versus Standard Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- POST OPERATIVE PAIN
研究概览
简要总结
The goal of this clinical trial is to learn if low pressure pneumoperitoneum and small incisions (low impact laparoscopy, LIL) works to reduce pain and improve pulmonary function in patients underwent to bariatric surgery.
It will also learn about the safety and patients' satisfaction of the procedure. The main questions it aims to answer are:
Does LIL lower post surgical pain and improve pulmonary function? Is LIL safe for obese patients? Researchers will compare LIL to standard laparoscopy performing sleeve gastrectomy in patients with obesity.
Participants will:
be randomised to LIL group or standard laparoscopy. After the operation the researchers will evaluate the pain and the efficiency of lung ventilation at pre-established intervals. after 3 months the patients will complete a questionnaire on aesthetic satisfaction and overall satisfaction.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 years-old and 65 years-old
- •BMI (Body Mass Index) >35 Kg/m2 and < 45 Kg/m2;
- •Patients candidate to sleeve gastrectomy
排除标准
- •Patients with neurological and/or psychiatric disorders
- •Patients with Chronic Pain Syndrome
- •Patients with a history of surgical procedures using a laparotomic approach in the upper abdominal quadrants
研究组 & 干预措施
Low Pneumoperitoneum Laparoscopy with microsurgery
干预措施: low pneumoperitoneum laparoscopy with microsurgery (Procedure)
standard laparoscopy
干预措施: standard laparoscopy (Procedure)
结局指标
主要结局
POST OPERATIVE PAIN
时间窗: FROM THE ENTER IN PACU TO 36 HOURS POST- SURGERY
Post-operative pain (AS REST PAIN AND MOVIMENT PAIN) will be assessed using the Numeric Pain Rating Scale (NRS), which rates pain from 0 to 10. 0 is defined as no pain, while 10 represents the maximum pain. 0 is the best result, 10 the worst. The questionnaire will be administered in the PACU and at 6, 12, 24, and 36 hours after the end of the procedure.
Pulmonary performance
时间窗: from surgery to 24 hours post-surgery
Efficiency of ventilation will be evaluated recording the values of Maximum Inspiratory Pressure (MIP), maximum expiratory pressure (MEP), Peak expiratory flow (PEF)
次要结局
- Rate of conversion to standard laparoscopy(from the beginning of surgery to the end of surgery)
- Rate of laparotomy conversion(from the beginning of surgery to the end of surgery)
- USE OF Analgesics(from surgery to 36 hours post-surgery)
- operative time(from the surgical incision to the last skin stitch)
- The time to first flatus(From the end of surgery up to 48 hours post-surgery)
- Ambulation Time(From the end of surgery up to 24 hours post-surgery)
- Liver Function(first and second post-operative day)
- Post-operative hospital stay(from the day of surgery up to 30 days)
- Postoperative complications(from surgery to 30 days after surgery)
- First Operator Comfort(during surgery)
- Aesthetic satisfaction(from surgery to 3-month post surgery)