What Laxative Should be Used After Hip Fracture Surgery?

Phase

Condition

Osteoporosis

Treatment

A combination of macrogol 3350 and electrolytes and bisacodyl

Macrogol 3350 and electrolytes

Bisacodyl

Clinical Study ID

NCT06455813

Laxatives26092019

Ages 65-110
All Genders

Study Summary

To conduct a randomized clinical trial to determine how best to prevent constipation after hip fracture surgery using laxatives.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Acute hip fracture surgery patients from one of two orthopedic departments fromhospitals in the Southern Region of Denmark.
Age≥ 65 years
The patients should be able to speak and understand Danish.

Exclusion

Exclusion Criteria:

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 ogIV
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: <125mmol/l)
Allergies to the ingredients
Pregnant women can not be included but the women are expected to bepostmenopausal why pregnancy test are not performed

Study Design

A combination of macrogol 3350 and electrolytes and bisacodyl

October 07, 2024

January 31, 2027

Study 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 1:1:1, 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, i.e. 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.

Connect with a study center

Hospital Lillebælt, Kolding Hospital
Kolding,
Denmark
Active - Recruiting
Odense University Hospital, Svendborg Hospital
Svendborg,
Denmark
Active - Recruiting

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