Importance of Surgical Approach for Hysterectomies on Metabolic Effects Regarding Development of Insulin Resistance and Subsequent Recovery. A Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Insulin resistance
研究概览
简要总结
Insulin resistance is a key reaction to surgery and trauma and reflects the degree of metabolic stress. With greater degree of insulin resistance the development of complications increase, in particular infectious complications. The aim of this study is to determine if robotic assisted total laparoscopic hysterectomy induces less insulin resistance compared to abdominal hysterectomy. Insulin resistance is measured by the hyperinsulinemic normoglycemic clamp method. In addition inflammatory factors and clinical recovery will be measured.
详细描述
This is a prospective randomized controlled single center study. Primary screening will take place in the gynecological ward of Orebro University hospital according to the inclusion and exclusion criteria. 20 patients will be enrolled. All participants are randomized between robotic assisted total laparoscopic hysterectomy and total abdominal hysterectomy.
The main purpose of this study are to determine if robotic assisted laparoscopic hysterectomy induces less insulin resistance compare to abdominal hysterectomy. Both patients with benign and malignant disease are included. In addition inflammatory factors such as IL-6 and CRP are measured and clinical recovery is measured.
Each patient will be studied twice using the hyperinsulinemic normoglycemic clamp, a method that now is the gold standard for determining insulin sensitivity. During the clamp insulin is infused intravenously to attain an elevation at levels seen after an abnormal meal. At the same time glucose is infused to balance the effect of insulin and to maintain normal blood glucose level. The amount of the glucose infusion needed is the level of insulin sensitivity. The clamp procedure is performed before surgery as a control measure and the morning after surgery to yield the relative change in insulin sensitivity caused by the operation (postoperative insulin resistance). Before the onset of the infusion, and after 60 minutes of steady state during insulin stimulation, blood is collected for the analysis of immune function. This is also collected 3 hours after surgery.
A 6 minutes walk test is performed before surgery and the day after surgery, in order to determine a more clinical measure on recovery.
In addition demographic and clinical data are systematically collected during the hospital stay and 30 days after.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •Scheduled to total hysterectomy and/or bilateral salpingo-oophorectomy (BSOE).
- •Both malignant or benign indications
- •The operation should be technically possible to perform with laparoscopy or by abdominal incision, including approval from an anesthesiologist
- •Acceptance to participate in the study and signed written informed consent document
- •Proficiency in Swedish language
排除标准
- •The operation is anticipated to comprise more than the hysterectomy + BSOE
- •Diabetes mellitus
- •Severe chronic pain or massive pain medication
- •Severe inflammatory disease like active severe endometriosis or inflammatory bowel disease
- •Known severe adhesions in the abdomen
- •Contraindications on non steroidal analgesia
- •Medication with drugs or disease affecting insulin resistance for example cortisone
- •Mentally disabled women who cannot fill in the questionnaires or understand the consequences of participating in a trial
- •Severe psychiatric disease or on medication for psychiatric disease so that the physician consider participation in the trial inappropriate
研究组 & 干预措施
Robot assisted laparoscopic hysterectomy
Robot assisted laparoscopic total hysterectomy
干预措施: Robot assisted laparoscopic hysterectomy (Procedure)
Abdominal hysterectomy
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.
干预措施: Abdominal hysterectomy (Procedure)
结局指标
主要结局
Insulin resistance
时间窗: 3 weeks
Insulin resistance is measured by the hyperinsulinemic normoglycemic clamp, a method that now is the golden standard for determining insulin sensitivity. The clamp is measured 1-2 weeks before surgery and on the morning after surgery.
次要结局
- Changes in biomarkers of inflammation and the immune system.(3 weeks)
- complications(4 weeks)
- 6 minutes walk test(3 weeks)
- postoperative outcomes(4 weeks)
研究者
Kerstin Nilsson MD
PhD
Region Örebro County