What Laxative Should be Used After Hip Fracture Surgery?

Oral Laxatives After Hip Fracture Surgery: A Randomised Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Drug: Macrogol 3350 and electrolytes; Drug: Bisacodyl; Drug: A combination of macrogol 3350 and electrolytes and bisacodyl

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.

• Study Type: Interventional
• Enrollment (Estimated): 375
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Carina Lundby; Email: Carina.Lundby.Olesen@rsyd.dk
• Study Contact Backup: Name: Anton Pottegård; Phone Number: 0045 28913340; Email: Anton.Pottegard@rsyd.dk

Study Locations

• Denmark
  • Kolding, Denmark
    • Recruiting
    • Hospital Lillebælt, Kolding Hospital
    • Contact: Ane Simony; Phone Number: +45 2445 3742; Email: Ane.Simony1@rsyd.dk
  • Svendborg, Denmark
    • Recruiting
    • Odense University Hospital, Svendborg Hospital
    • Contact: Bjarke Viberg; Phone Number: +45 28669059; Email: Bjarke.Viberg@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Macrogol 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; Other Names: Gangiden
Active Comparator: Bisacodyl; Enteric coated tablet Bisacodyl (ATC code A06AB02) 5 mg, 2 tablets daily which is administered orally daily (in the evening) during admission	Drug: 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; Other Names: Dulcolax
Active Comparator: 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	Drug: A 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; Other Names: A combination of Gangiden og Dulcolax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients who will need rescue medication (Bisacodyl)	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	72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first bowel movements	Time to first bowel movements (in hours after finished surgery)	hours up to 240 hours
Length of hospital stay	Length of hospital stay of the index admission from admission to discharge	days up to 10 days
Number of patients who are readmitted at hospital	The part of patients who are readmitted at hospital 30 days after discharge hospital	30 days
Number of patients who have emergency room visits	The proportion of patients who have emergency room visits within 30 days of discharge hospital	30 days
Constipation defined from the Bristol Stool Scale	constipation defined from the Bristol Stool Scale with type 1-7 where type 1 is constipation and type 7 is diarrhea and use/no use of rescue medication (bisacodyl)	daily up to 10 days
Constipation score	Calculated score based of The Patient Assessment of Constipation symptoms Questionnaire from 0-48 where 48 is most severe constipation and use/no use of rescue medication (bisacodyl)	daily up to 10 days

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Independent Research Fund Denmark
• Investigators: Study Director: Carina Lundby, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Gastrointestinal Agents; Laxatives; Cathartics; Polyethylene glycol 3350; Bisacodyl
• Other Study ID Numbers: Laxatives26092019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No