A Comparison of Postoperative Pain Results According to Pressure to Form Pneumoperitoneum During Robot-assisted Single-port Cholecystectomy; a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Visual Analogue Score(VAS)
研究概览
简要总结
This study showed the difference in postoperative pain between the groups that performed surgery with the low-pressure pneumoperitoneum and the group that performed surgery in the standard-pressure pneumoperitoneum when robotic single-hole cholecystectomy was performed.
The primary purpose of the study was to compare the differences in the visual analog scale (VAS) between the two groups and to demonstrate the effectiveness of pain relief after surgery.
Secondly, the effect of the low-pressure pneumoperitoneum on the patient's postoperative recovery and outcome was compared with the control group by comparing the length of stay, operation time, and postoperative complications.
详细描述
Laparoscopic cholecystectomy was the most common treatment method for gallbladder-related diseases, and robotic cholecystectomy was also currently being performed. Many patients complained pain around the wound, shoulder and back after surgery. Several methods had been attempted to reduce postoperative pain, previous studies showed that oral medications such as NSAIDS, administration of local anesthetics in wounds and abdominal cavity, low-pressure penumoperitoneum, humidification of intraperitoneal washing fluid, And active residual gas suction in the abdominal cavity had been found to relieve postoperative pain.
Robotic cholecystectomy, similar to laparoscopic cholecystectomy, also formed pneumoperitoneum to secure the surgical space during operation. Based on the results published in various studies, it had known that the most effective method of pain relief for laparoscopic pain was to create low-pressure pneumoperitoneum.
In this study, investigators attempted to prove the effectiveness of low pressure pneumoperioneum through a prospective randomized controlled trial between the experimental group with the low-pressure pneumoperitoneum and the control group with the standard-pressure pneumoperitoneum during robotic single-hole cholecystectomy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent elective gallbladder surgery
- •Cholelithiasis
- •Chronic cholecystitis
- •Gallbladder polyps
- •Gallbladder adenoma
- •Porcelain gallbladder
排除标准
- •Acute cholecystitis patient group
- •Necrotic gallbladder
- •Collapsed gallbladder
- •Gallbladder pustosis
- •Gallbladder emphysema
- •Hemorrhagic gallbladder
- •Perforated gallbladder
- •cholecystitis with a gallbladder thickness of 4 mm or more on CT or ultrasound
- •cholecystitis with adhesions to surrounding organs due to inflammation of the gallbladder
- •Patient group performing surgery concurrently due to other organ diseases
- •Immunosuppressive patient group
- •Transplant patient group: Liver transplant patient group (PSLT), Kidney transplant patient group (PSKT)
- •AIDS patients group
- •Patient group with history of open abdominal surgery
- •Transplant group during open surgery
- •Patients under 19 years of age.
结局指标
主要结局
Visual Analogue Score(VAS)
时间窗: 24 hours after surgery
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain.
次要结局
- postoperative complication(Participants will be followed for the duration of hospital stay, an expected average of 2 days)
- hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 2 days)
- operation time(Participants will be followed for the duration of hospital stay, an expected average of 2 days)
研究者
Taeho Hong
Professor
Seoul St. Mary's Hospital