A multi-site cluster randomised controlled trial comparing the severity of constipation symptoms experienced by palliative care patients receiving usual care compared to those diagnosed and managed according to the underlying pathophysiology.

Flinders University0 个研究点目标入组 210 人开始时间: 2011年7月8日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Life-limiting disease
•Aged 18 years or older
•Regular use of laxatives
•Already receiving one or more laxatives for at least 48 hours, as suggested in the Australian Palliative Care Therapeutic Guidelines
•Sufficient proficiency in English to provide consent, complete the study questionnaires and telephone interviews
•Willing and able to undertake diagnostic interventions
•Able to give fully informed written consent

•Short-term constipation due to problems such hypercalcaemia or vinca alkylating agents occurring within one month of study
•History of bowel obstruction or at high risk of bowel obstruction (peritoneal disease)
•History of bowel surgery
•Local conditions of the peri-anal area and rectum that would contribute to pain on defecation, require specialist interventions and therefore preclude the necessary investigatons to continue on this study including faecal impaction, anal fissure, haemorrhoids, anal prolapse or rectocele >2cm in size
•Thrombocytopenia of <50,000 platelets per microlitre precluding rectal interventions
•Allergy to latex
•Participants who have participated in a clinical study of a new laxative within one month prior to study entry
•Women who are pregnant. Patients at risk of pregnancy must have appropriate and effective contraceptive in place (or appropriate advice from their doctor regarding appropriate birth control)
•Any other condition that would interfere with study procedures or assessments in the opinion of the investigators

发起方