Fast Track Surgery in Whipples Procedure - Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Fast track & conventional protocols are compared in Whipple’s surgery based on early Ryle’s tube removal, early orals, early mobilization, early removal of drainage tube, continuous epidural analgesics and the outcome will be measured
研究概览
简要总结
The study will include only selected patients who fit in our inclusion criteria & undergo pancreatico-duodenectomy at our Institute of Surgical Gastroenterology & Liver Transplantation, Govt Stanley medical College & Hospital.
A total of 44 lots, 22 for fast track & 22 for conventional protocol will be kept in a container and allowing patients to choose the follow up protocol under randomization at the time of admission and will be followed accordingly.
Fast track will be considered as study group and will be compared to control (conventional group)
The purpose of the study will be explained to the subjects and a written informed consent
will be obtained
Preoperative parameters- detailed demographic profile, clinical symptoms with duration, clinical findings, blood investigations reports (complete blood counts, renal function tests with electrolytes, blood sugar, liver function test), viral marker status (HBsAg, Anti HCV), upper GI endoscopy, findings of radiological imaging (x ray chest, usg abdomen with doppler, CECT abdomen / MRI abdomen & CA 19-9 values were recorded.
After assessing operability, classical pancreaticoduodenectomy to be done. Post operatively each patient will be followed according to the group alloted and recovery will be compared in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients undergoing pancreaticoduodenectomy(lap/open) for either one of the following diagnosis during the study period in our SGE department Carcinoma(ductal) head of pancreas Periampullary carcinoma Distal CBD growth Duodenal carcinoma Cystic neoplasm of pancreas head Neuroendocrine tumour of pancreas head Chronic calcific pancreatitis with head mass.
排除标准
- •Consent not given by the patient Locally advanced or distant metastasis (who undergo palliative bypass) Having more than 2 co-morbidities Pre operative systemic organ failure ASA- IV / V.
结局指标
主要结局
Fast track & conventional protocols are compared in Whipple’s surgery based on early Ryle’s tube removal, early orals, early mobilization, early removal of drainage tube, continuous epidural analgesics and the outcome will be measured
时间窗: 2-4 weeks
次要结局
- comparing the total hospital stay of patients followed up with conventional & fast track method in post operative whipples patients(4-6 weeks)
研究者
Dr Amarnath G
Government Stanley Medical College