None listed
Conditions
Brief summary
Constipation is a common, distressing and serious symptom, affecting between 50-90% of people referred to specialist palliative care services, with 40-70% of people failing to achieve adequate symptom control. The number of people failing to achieve satisfactory symptom relief is not acceptable as inadequate symptom relief is responsible for adding to individual and societal burdens. In palliative care, decisions regarding the prescription of laxatives are based predominantly on clinical experience and institutional approaches. Many of these do not consider the pathophysiological basis that underlies the symptom of constipation. This approach is very dissimilar to that adopted by gastroenterologists in the treatment of non-palliative care patients. The most striking difference is the limited information to categorise the palliative population into the groupings that gastroenterologists would routinely use, thereby limiting the ability to tailor interventions to improve symptom control. This study will aim 1). To develop an approach to constipation that enables the underlying problems (slow transit of colonic contents, delayed outlet of colonic contents or an overlap of these problems), to be quantified in palliative care patients using well-tolerated and validated diagnostic methods; 2). To compare whether the constipation severity of those patients randomly allocated to a mechanistic approach to the assessment and treatment of constipation within different sub categories have better patient outcomes than people palliated using standard current clinical care.
Interventions
Participants randomised to the intervention arm will undertake the comprehensive assessment at the commencement of the study, allowing allocation to one of three diagnostic sub-categories. These include 1) Slow transit alone; 2) Slow transit and delayed outlet; and 3) Delayed outlet alone. For each category, general and targeted interventions appropriate to the patient population will be trialed. These include general interventions such as hydration, exercise, toileting position and prescribing
Participants randomised to the intervention arm will undertake the comprehensive assessment at the commencement of the study, allowing allocation to one of three diagnostic sub-categories. These include 1) Slow transit alone; 2) Slow transit and delayed outlet; and 3) Delayed outlet alone. For each category, general and targeted interventions appropriate to the patient population will be trialed. These include general interventions such as hydration, exercise, toileting position and prescribing a toileting routine. Specific interventions for slow transit for example, will include the use of stimulant laxatives and for outlet delay will involve the prescription of a regular suppository. Participants randomised to the control groups will receive laxatives as recommended in the management of constipation by Australian Therapeutic Guidelines. The Australian-modified Karnofsky Performance Status (AKPS) will be used to assess eligibility. All patients will undergo the Bowel Symptom Questionnaire (BSQ), Patient Assessment of Constipation Symptoms (PAC-SYM) and the Patient Assessment of Constipation Quality of Life (PAC-QOL) on entry into the study regardless of which group they are allocated to. Family distress questionnaire will also be collected on entry into the study. Clinical data and diagnostic interventions will also be collected with the investigations including measurement of colon transit times, and assessment of the structures of defecation with balloon expulsion and anal manometry. The investigations will require one week to complete. For those randomised to the intervention arm, participants will undertake the diagnostic interventions prior to commencing the 14 day study period. Whilst this is underway, participants’ constipation will be managed as per usual care, and they will be asked to complete a 7 day bowel diary. For those randomised to the usual practice arm, participants will be invited to participate in a sub-study where they undergo the same diagnostic interventions as the intervention group. All participants will be assessed at day 14 with the PAC-SYM and the PAC-QOL, and family distress questionnaire. Whilst on the study, all people will be asked to fill out a daily diary which includes a bowel chart that records actual bowel movement and type, abdominal pain or bloating, and laxatives used. Finally, the ROME III Questionnaire to allow quantification of the numbers of people who come to palliative care services with a past history of functional constipation, and will allow an assessment as to whether this impacts the severity of symptoms they now experience. People will be stratified according to whether they had a feeling of complete evacuation less or more than 2 days per 7 days. Such stratification will allow a comparison of this with the PAC-SYM and PAC-QOL. The Symptom Assessment Scale (SAS) and any adverse effects will be collected as part of this diary. Participants will also receive a telephone call on day 7 to collect data on diary compliance, side effects and medical care.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed