RecruitingPhase 4NCT06455813

What Laxative Should be Used After Hip Fracture Surgery?

Oral Laxatives After Hip Fracture Surgery: A Randomised Controlled Trial


Sponsor

Odense University Hospital

Enrollment

375 participants

Start Date

Oct 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 65 YearsMax Age: 110 Years

Inclusion Criteria3

  • 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 Criteria16

  • 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

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Interventions

DRUGBisacodyl

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 peristaltic-promoting agents

DRUGMacrogol 3350 and electrolytes

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 peristaltic-promoting agents

DRUGA combination of macrogol 3350 and electrolytes and bisacodyl

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 peristaltic-promoting agents


Locations(2)

Hospital Lillebælt, Kolding Hospital

Kolding, Denmark

Odense University Hospital, Svendborg Hospital

Svendborg, Denmark

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NCT06455813


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