Peritoneal Cavity Conditioning During Laparoscopic Surgery Decreases Postoperative Pain, Inflammatory Reaction and Postoperative Adhesions
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- adhesion formation after laparoscopic surgery
研究概览
简要总结
Full conditioning of the peritoneal cavity during laparoscopic surgery will decrease post-operative pain, inflammation and adhesion formation.
Full conditioning will decrease an inflammatory response of the peritoneum and decrease pain and adhesion formation.
详细描述
Randomized controlled trial (RCT) comparing carbon dioxide to full conditioning (addition of oxygen, nitrous oxide, humidification and temperature control, dexamethasone and Hyalobarrier gel) Women undergoing laparoscopy for endometriosis, myomectomy or adhesiolysis will be randomized to either group and will be compared for pain (VAS scores); inflammation (White blood cells, CRP) and adhesions scored by second look laparoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women undergoing laparoscopic excision of deep endometriosis (stratum 1), excision of endometrioma's (stratum 2) or excision of uterine myoma's (stratum 3) since this is severe surgery, associated with severe postoperative adhesions and since for most of these women fertility is important and hence the second look laparoscopy can be beneficial.
- •Signed informed consent
排除标准
- •women with a pre-existing condition increasing the risk of surgery such as clotting disorders, heart or lung impairment etc.-Any condition that might interfere with inflammatory parameters such as immunodeficiency, chronic inflammatory disease as Crohn's disease.
- •Pregnancy
- •Conditions associated with chronic pain as peripheral neuropathy, pathology of the vertebral column and osteo-articular disease. Conditions causing acute pain e.g. abdominal trauma
- •a known allergic reaction to Hyalobarrier Gel Endo®
- •A bowel lesion requiring a single or double layer suture. (given that for none of the anti-adhesion barriers safety has been proven following bowel lesions and suture)
研究组 & 干预措施
Full conditioing
Intervention by alteration of laparoscopic gas with addition of oxygen and nitrous oxide, regulation of humidification and temperature (32°C), injection of 5mg Dexamethasone and application of Hyalobarrier Gel Endo (Nordic Pharma) at the surgical wound
干预措施: full conditioning (Procedure)
carbon dioxide
induction pneumoperitoneum with carbon dioxide 100%
干预措施: standard pneumoperitoneum (Procedure)
结局指标
主要结局
adhesion formation after laparoscopic surgery
时间窗: 2 weeks after primary surgery
second look laparoscopy to assess adhesions formed after initial surgery
次要结局
- inflammation(recorded until 3 days after surgery)
- time to first flatus and stool(recorded until 3 days after surgery)
- Post-operative pain(recorded until 3 days after surgery)
研究者
Jasper Verguts
MD, PhD
University Hospital, Gasthuisberg