What Laxative Should be Used After Hip Fracture Surgery?

Официальное название

Oral Laxatives After Hip Fracture Surgery: A Randomised Controlled Trial

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат 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
• Препарат 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
• Препарат 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

Первичные конечные точки

• The proportion of patients who will need rescue medication (Bisacodyl) [Срок оценки: 72 hours after surgery]

Вторичные конечные точки (6)

• Time to first bowel movements [Срок оценки: hours up to 240 hours]
• Length of hospital stay [Срок оценки: days up to 10 days]
• Number of patients who are readmitted at hospital [Срок оценки: 30 days]
• Number of patients who have emergency room visits [Срок оценки: 30 days]
• Constipation defined from the Bristol Stool Scale [Срок оценки: daily up to 10 days]
• Constipation score [Срок оценки: daily up to 10 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 2 центра

• Hospital Lillebælt, Kolding Hospital — Kolding
• Odense University Hospital, Svendborg Hospital — Svendborg

Идентификаторы

NCT: NCT06455813 · Laxatives26092019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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