Clinical trial NCT06455813: What Laxative Should Be Used After Hip Fracture Surgery?
Official title: Oral Laxatives After Hip Fracture Surgery: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hip Fractures
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Independent Research Fund Denmark
First posted: 2024-06-12
Enrollment: 375
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

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 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

Primary outcomes:
measure: The proportion of patients who will need rescue medication (Bisacodyl)
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Time to first bowel movements
timeFrame: hours up to 240 hours
measure: Length of hospital stay
timeFrame: days up to 10 days
measure: Number of patients who are readmitted at hospital
timeFrame: 30 days
measure: Number of patients who have emergency room visits
timeFrame: 30 days
measure: Constipation defined from the Bristol Stool Scale
timeFrame: daily up to 10 days
measure: Constipation score
timeFrame: daily up to 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Odense University Hospital
name: Carina Lundby
role: STUDY_DIRECTOR
References: