Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455813
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-03
Brief Title:
What Laxative Should Be Used After Hip Fracture Surgery
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Oral Laxatives After Hip Fracture Surgery a Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To conduct a randomized clinical trial to determine how best to prevent constipation after hip fracture surgery using laxatives
Detailed Description:
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
The project is a randomized controlled trial in ratio 111 where the patients assigned to two different orthopedic surgery departments are assigned to either have one of two drugs bisacodyl macrogol or both types of anti-constipation drugs It is calculated that 375 patients will be included in the trial ie 125 patients in each group It is expected that patients will be evenly included distributed between two hospitals
The patients will respectively be given macrogol 3350 and electrolytes ATC code A06AD65 which is administered as the content of 2 sachets Bisacodyl ATC code A06AB02 5 mg 2 tablets or a combination of both in half the dose
All laxatives are administered orally in the evening on the day of surgery the next standard administration time at 10 pm and it is known to both patients and staff which trial medication each patient is receiving The patients stool frequency degree of constipation and side effects of the medication as well as pain nausea and flatulence are scored once a day using the Bristol Stool Scale Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire If the first defecation has not occurred 72 hours after the end of the operation the patients in all three groups are transferred to treatment with peristalsis-promoting agents Bisacodyl 5 mg 2 tablets The patients stay in the trial and get the trial medication they are assigned to unless an orthopedic surgeon assesses otherwise
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
The project is a randomized controlled trial in ratio 111 where the patients assigned to two different orthopedic surgery departments are assigned to either have one of two drugs bisacodyl macrogol or both types of anti-constipation drugs It is calculated that 375 patients will be included in the trial ie 125 patients in each group It is expected that patients will be evenly included distributed between two hospitals
The patients will respectively be given macrogol 3350 and electrolytes ATC code A06AD65 which is administered as the content of 2 sachets Bisacodyl ATC code A06AB02 5 mg 2 tablets or a combination of both in half the dose
All laxatives are administered orally in the evening on the day of surgery the next standard administration time at 10 pm and it is known to both patients and staff which trial medication each patient is receiving The patients stool frequency degree of constipation and side effects of the medication as well as pain nausea and flatulence are scored once a day using the Bristol Stool Scale Verbal Rank Scale and Patient Assessment of Constipation symptoms Questionnaire If the first defecation has not occurred 72 hours after the end of the operation the patients in all three groups are transferred to treatment with peristalsis-promoting agents Bisacodyl 5 mg 2 tablets The patients stay in the trial and get the trial medication they are assigned to unless an orthopedic surgeon assesses otherwise
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None