Insulin Therapy Reduce Post-Operative Inflammatory Response After Curative Colorectal Cancer Resection: Randomization Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- The anti-inflammatory effects of intraoperative hyper-insulinimic euglycemic therapy in patients undergoing colorectal cancer surgery.
研究概览
简要总结
Research Problem:
Surgical stress induces inflammation and postoperative immuno-suppression, which are risk.
factors for both post-operative complication and possible disease recurrence. Colorectal cancer is in the top 5 malignancies in the Kingdome and the highest incidence in males. Recurrent disease locally or distally occurs in 35% of patients and is the leading cause of death in these patients. Despite the new era of laparoscopic surgery, still surgical stress is present and equally traumatic to the conventional open colorectal resection, earlier studies showed no major differences in post-operative inflammatory and immunological reactions. The previous studies revealed the anti-inflammatory effects of the hyper-insulinimic euglycemic therapy. Benefits observed in both major liver resection and in cardiac surgery. The anti-inflammatory effect reduced the surgical stress and postoperative inflammation.
The hypothesis is "Can intraoperative hyper-insulinimic euglycemic infusion reduce post operative inflammation and immunomodulation in colon cancer patients undergoing a curative surgery?"
Research methodology Triple blinded randomized controlled study with estimated sample size of 144 patients of non-metastatic colorectal cancer patients operated at King Saud University Medical city with a confirmed diagnosis of colon adenocarcinoma. Patients Consented will undergo computer randomization to receive intraoperative hyper-insulinimic normoglycemic infusion (experimental) or standardized insulin sliding scale and saline (control). A common preoperative and postoperative pathway with standardized management and pain control in both groups.
Outcomes will be measured via a battery of laboratory test consist of routine labs, inflammatory markers and immunological markers to be repeated at fixed timed intervals. All patients will be followed by regularly for 5 years.
Research objectives
Primary outcomes to examine:
- The anti-inflammatory effects of intraoperative hyper-insulinimic euglycemic therapy in patients undergoing colorectal cancer surgery.
- The immunomodulatory effect of intraoperative hyper-insulinimic euglycemic infusion
Secondary outcomes:
- Thirty days post-operative morbidity.
- Overall survival rate.
- Disease-free survival rate.
详细描述
Aim & hypothesis:
The aim is to investigate the effect of the same protocol in colorectal surgery and to further delineate the effect on perioperative inflammation, immunosuppression and clinical outcome. This is an original approach, as this protocol was never used in bowel surgery.
The hypothesis predicts a reduced inflammation and resulting immunomodulation due to the anti-inflammatory effect of hyper-insulinmic euglycimic infusion, and improved postoperative morbidity and oncological outcome.
Study Design and Participants:
With the approval of the ethics board at King Saud University Medical city (KSUMC) a triple blinded randomized controlled study of operable resectable CRC patients of consented to be randomized to receive hyperinsulinimic normoglycemic protocol (experimental) or standardized insulin sliding scale (control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age > 18 years
- •Documented CRC by histopathology
排除标准
- •Patient not consenting to the study or refused.
- •Metastatic disease at the time of diagnosis.
- •Contraindications to insulin
- •Pregnancy
研究组 & 干预措施
Intervention group.Hyper insulinemic euglycemic clamp
After obtaining a baseline preoperative lab set blood glucose value, 2 U/kg bolus of insulin to be administered IV followed by an infusion of 2 U/ kg/min.fiver - Ten minutes after starting the insulin (Human regular insulin) ) infusion, and when the blood glucose is <6.1 mmol /L (110 mg /dL). an Infusion of dextrose 20% supplemented with pottasium phosphate (30 mmol/L ) to be administered. In the operating room, blood glucose levels were measured every 5-15 minutes, and the dextrose infusion rate was adjusted to maintain arterial glycemia between 3.5 and 6.1 mmol/L (63-110 mg/dL). timed intra operative lab assessment to be obtained.
干预措施: Hyper insulinemic euglycemic clamp (Drug)
结局指标
主要结局
The anti-inflammatory effects of intraoperative hyper-insulinimic euglycemic therapy in patients undergoing colorectal cancer surgery.
时间窗: 1 month
effect on Inflamatory profile namely levels of Tnf- Alpha , IL-8 , IL-6 , IL-10 , IL-1B,IL-18 , IFNγ, MIp1-Alpha , MMP-8 , TGF Beta , CRP
次要结局
- The immunomodulatory effect of intraoperative hyper-insulinimic euglycemic infusion.(1 month)
研究者
Mazen Hassanain
Assistant Professor & Counsultant HPB and transplant Surgeon
King Saud University