Oral Laxatives After Hip Fracture Surgery: A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 375
- 试验地点
- 2
- 主要终点
- The proportion of patients who will need rescue medication (Bisacodyl)
研究概览
简要总结
To conduct a randomized clinical trial to determine how best to prevent constipation after hip fracture surgery using laxatives.
详细描述
Background:
Acute constipation is very common in connection with major operations. Constipation is a complication that can prolong hospital stays, increase nursing time and healthcare costs. Up to 70% experience constipation after surgery for a hip fracture. Prevention of constipation is considered an important part of treatment after hip surgery, but although the use of anti-constipation drugs is widespread, there are no studies of sufficient quality to show how and with what means constipation is best treated. For the same reason, in Denmark there is great variation in the approach to preventive treatment - and thus also the treatment result.
Aim:
The aim is to investigate how to prevent constipation best after hip surgery using laxatives.
Method, design, intervention og investigation procedures:
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
- 65 Years 至 110 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute hip fracture surgery patients from one of two orthopedic departments from hospitals in the Southern Region of Denmark.
- •Age≥ 65 years
- •The patients should be able to speak and understand Danish.
排除标准
- •Patients:
- •with known chronic constipation (defined from Wexner constipation score)
- •with known use of laxatives at admission
- •who participate in other similar clinical studies
- •who is terminally ill
- •who is restraint
- •who is in isolation
- •with severe heart disease defined as New York Heart Association (NYHA) III og IV
- •with severe chronically inflammatory bowel disease
- •with acute abdominal surgical conditions, eg. ileus, obstruction or perforation
- •with dysphagia where the patient can not swallow tablets/oral liquids
- •with toxic megacolon
- •with gastric emptying disorder
- •with severe electrolyte disorder (P-kalium: < 2.5 mmol/l og P-natrium: <125 mmol/l)
- •Allergies to the ingredients
- •Pregnant women can not be included but the women are expected to be postmenopausal why pregnancy test are not performed
研究组 & 干预措施
Macrogol 3350 and electrolytes.
Powder for oral solution in sachet Macrogol 3350 and electrolytes (ATC code A06AD65) which is administered orally as the content of 2 sachets daily (in the evening) during admission
干预措施: Macrogol 3350 and electrolytes (Drug)
Bisacodyl
Enteric coated tablet Bisacodyl (ATC code A06AB02) 5 mg, 2 tablets daily which is administered orally daily (in the evening) during admission
干预措施: Bisacodyl (Drug)
A combination of macrogol 3350 and electrolytes and bisacodyl
Powder for oral solution in sachet macrogol 3350 and electrolytes (ATC code A06AD65) which is administered orally daily (in the evening) as the content of 1 sachet given in combination with enteric coated tablet Bisacodyl (ATC code A06AB02) 5 mg, 1 tablet orally daily (in the evening) during admission
干预措施: A combination of macrogol 3350 and electrolytes and bisacodyl (Drug)
结局指标
主要结局
The proportion of patients who will need rescue medication (Bisacodyl)
时间窗: 72 hours after surgery
Part of patients in each group who needs rescue medication after 72 hours or rescue medication before 72 hours on behalf of a medical assessment
次要结局
- Time to first bowel movements(hours up to 240 hours)
- Length of hospital stay(days up to 10 days)
- Number of patients who are readmitted at hospital(30 days)
- Number of patients who have emergency room visits(30 days)
- Constipation defined from the Bristol Stool Scale(daily up to 10 days)
- Constipation score(daily up to 10 days)