Day-case or Inpatient Care Following Inguinal Hernia Repair in Elderly Patients
Randomized Clinical Trial Comparing Day-case and Inpatient Care Following Inguinal Hernia Repair in Elderly Patients
研究概览
详细说明
For repair of inguinal hernia, standard open mesh repair methods were used. For anaesthesia, local infiltration with lidocaine (10 mg/ml) and light intravenous sedation with propofol and fentanyl were primarily used. Reasons for choosing spinal or general anaesthesia were registered. For postoperative pain relief bupivacaine (5mg/ml) 10 ml was infiltered into the wound and nonsteroidal anti-inflammatory analgesics (NSAID) and paracetamol combined with codeine were prescribed, when suitable. Day-case patients were discharged home according to commonly approved criteria. Inpatients stayed on the hospital ward overnight. All patients received the same preoperative and postoperative instructions orally and in writing. Physical activity was not restricted after the operation, and patients were encouraged to resume to normal life as soon as possible.
At the hospital, patient characteristics, type of anaesthesia, duration of surgery, duration of hospital stay and perioperative complications including unplanned overnight admissions were registered.
The study nurse interviewed all patients on the 1st and 14th postoperative day (POD) by telephone, using standardised follow-up questionnaires. The investigated variables on both dates included: satisfaction with treatment, patient-reported overall condition and functional capacity compared to the preoperative state, intensity of pain and use of pain medication. On POD 1, patients were inquired whether convalescence had been as expected, and asked to specify if not. Also the incidence and intensity other symptoms apart from pain were questioned. On POD 14 patients were questioned of unplanned contacts with primary healthcare, unplanned hospital visits, readmissions, and corresponding reasons.
Patient satisfaction with treatment in the operating room and following arrival to the postanaesthesia care unit was evaluated numerically (0-10), using the numeric rating scale (NRS), with 0 indicating lowest, and 10 highest possible satisfaction as rated by the patient. Intensity of postoperative pain was evaluated by NRS. Overall condition and functional capacity were evaluated using a 3 -point scale (good / moderate / poor). Health-related quality of life was measured using the RAND-36-instrument.
Patients were inquired about the degree of impairment in the groin area at the preoperative visit, and three months postoperatively.
Results are given as median (range) or mean (SD) as appropriate. Patient characteristics and surgery -related variables and NRS scores were compared using the Chi-square, Mann-Whitney-U and Kruskall-Wallis tests when appropriate. Intergroup comparisons were performed using the Wilcoxon test for related samples. P-values < 0.05 were considered statistically significant.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
HUS
-
Espoo、HUS、芬兰、00029
- Jorvi Hospital, Helsinki University Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- referral for open repair of inguinal hernia
Exclusion Criteria:
- severe comorbidity (ASA class IV, unstable ASA class III)
- postoperative care at home not available
- not willing to receive day-case care
- unable to understand numeric rating scale
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Day Surgery Group
discharge planned on day of surgery, inguinal hernia repair
|
inguinal hernia repair, discharge from the hospital on the day of surgery
|
|
有源比较器:Inpatient Group
overnight admission at the hospital, inguinal hernia repair
|
inguinal hernia repair, patient admitted overnight to hospital
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient satisfaction
大体时间:2 weeks postoperatively
|
satisfaction based on type of care
|
2 weeks postoperatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
short term outcome
大体时间:2 weeks postoperatively
|
rate of complications, unplanned admissions, unplanned visits to the hospital, unplanned visits to primary health care
|
2 weeks postoperatively
|
合作者和调查者
调查人员
- 首席研究员:Kristiina Mattila, MD PhD、Helsinki University Central Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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