Enhanced Recovery Versus Standard Recovery After Low-risk Pancreatoduodenectomy Identified With Acinar Cell Count or Total Pancreatectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Days until discharge from university hospital
研究概览
简要总结
In the study, the enhanced recovery after surgery (ERAS) program is applied to total pancreatectomy (TP) and low-risk pancreaticoduodenectomy (PD) patients identified by a small number of acinar cells in the cut edge of the pancreas. The research setting is randomized and controlled. All patients arriving at the Tampere University Hospital (TAUH) for PD or TP surgery are recruited into the study. Recruited patients are randomized to the ERAS protocol and to the standard protocol recovery program. The ERAS program differs from the normal care protocol preoperatively, intraoperatively and postoperatively as explained in the following section.
In the ERAS protocol, both on the previous day of the surgery and on the following days, the patient is discussed with the patient about the benefits of the protocol used and the recovery program objectives. The purpose is to motivate and encourage the patient. On the day of surgery, the patient's intake of food and fluids is allowed to be closer to the surgery and the patient is also given a carbohydrate drink two hours before surgery. The nasogastric tube set at the beginning of surgery is removed at the end of the surgery and peripancreatic or perihepatic drains are not routinely placed. After surgery, drinking is allowed after four hours and the patient is encouraged to move as actively as possible in the bed. On the first and second postoperative day, the patient is allowed to enjoy normal food and drink according to his or her ability, and pancreatic capsules are given in the course of food. Additionally, the analgesic to be administered through the epidural cannula is dosed as far as possible to allow mobilization of the patient. The discussion on the benefits and recovery targets of the ERAS protocol are continued. On the third postoperative day, the epidural infusion is discontinued and the pain medication is moved to opioid-based pain management. This is continued until specific criteria for passing to the follow-up care are met.
Typical complications (pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage) are registered during hospitalization and their severity ratings according to ISGPS, ISPGF and Clavien-Dindo classifications are also determined. Other variables registered are the number of intensive care days, situations requiring new surgeries, 30 and 90 day mortality, the completion time of the criteria for passing to follow up care, and the total length of hospitalization. In addition, the need for readmissions is registered. The implementation of the ERAS protocol is followed by a separate tracking template, in which the nurses record the progress of the goals specified in the protocol on a daily basis. The results of the study are analyzed with the intention-to-treat principle.
详细描述
In the study, the enhanced recovery after surgery (ERAS) program is applied to total pancreatectomy (TP) and low-risk pancreaticoduodenectomy (PD) patients identified by a small number of acinar cells in the cut edge of the pancreas. The research setting is randomized and controlled. All patients arriving at the Tampere University Hospital (TAUH) for PD or TP surgery are recruited into the study. Patients will be sent a handout of the study along with the letter of invitation for the surgery itself. Recruitment takes place at the first appointment of the surgery where the surgeon presents the study to the patient. If the patient wishes to participate in the study, the patient issues a signature on the consent form. They are randomized to this ERAS program for shortened recovery period and a standard protocol recovery program. Allocation to the groups takes place using opaque envelope-coded randomization codes. The research nurse prepares the envelopes in twelve patient randomization blocs.
To determine the low risk PD-patients recruited, the pathologial sample of the cut-edge of the pancreas is analyzed by pathologist during the surgery. If the pancreatic cut-edge contains less than 40% acinar cells, the patients is considered low risk patient. This method is based on earlier studies in our pancreatic research group. All TP patients are per se in the small complication risk group. Only those patients with a low risk of complications continue to be involved in the study in standardized or ERAS protocol groups according to the original allocation.
ERAS protocol consist of following actions in comparison to standard protocol:
First appointment:
- Enlightenment on the benefits and objectives of the ERAS protocol
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All PD or TP patients 18-99 years old
排除标准
- •Any other surgery than PD or TP
- •High risk patients
- •Refusal for the study
结局指标
主要结局
Days until discharge from university hospital
时间窗: Up to 24 weeks
Time in days since the entry to hospital on the surgery day to the discharge day to follow up care or home
次要结局
- Total number of complications(Postoperatively up to 24 weeks)
- Readmission frequency(From the discharge up to 24 weeks for any cause related to surgery)
- Days until discharge from follow up care(Up to 24 weeks)