What laxative after hip surgery?

Phase 1

Conditions: The aim is to investigate which constipation therapy is the most optimal choice for postoperative treatment in older patients after hip fracture surgery.
MedDRA version: 23.0Level: PTClassification code 10020100Term: Hip fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

Registration Number: EUCTR2019-003850-10-DK

Lead Sponsor: Hospital Pharmacy Funen, Research Department, Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 375

Inclusion Criteria

Hip fracture patients, age= 65 year will be included from three orthopedic departments from hospitals in the Southern Region of Denmark. The patients should be able to speak and understand Danish.

Pregnant women can not be included but the women are expected to be postmenopausale why pregnancy test are not performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 375

Exclusion Criteria

Patients:
• with known cronic 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 NYHA III og IV
• with severe cronically inflamatory bowel disease
• with acute abdomial surgical conditions, eg. ileus, obstruction or perforation
• with dysphagia where the patient can not swallow tablets/oral liquids
• with toxic megacolon
• with gastric emtying disorder
• with severe electrolyte disorder (P-kalium: < 2.5 mmol/l og P-natrium: <125 mmol/l)
• Allergies to the ingredients

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this randomized controlled study is to investigate which constipation therapy is the most optimal choice for postoperative treatment in older patients after hip fracture surgery.;Secondary Objective: Not applicable;Primary end point(s): Part of patients in each group who needs recue medication after 72 hours or rescue medication before 72 hours on behalf of a medical assessment;Timepoint(s) of evaluation of this end point: Hours after end surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to first bowel movements (in hours after finished surgery)<br>Length of hospital stay<br>Risk of readmission at hospital (part of patients who are readmitted at hospital)<br>Adverse reactions: Nausea, pain (by use of visual rank scale), flatulence, diarrhea/constipation defined from fra Bristol Stool Scale Constipation score: Patient Assessment of Constipation symptoms Questionaire <br>;Timepoint(s) of evaluation of this end point: 30 days