Constipation Clinical Trial
Official title:
An Evaluation of the Efficacy and Safety of a Polyethylene Glycol (PEG) Based Bowel Protocol for the Management of Constipation in Peritoneal Dialysis Patients: A Pilot Study
Constipation is a common condition, which occurs one in four Canadians. Maintaining regular
bowel movements is imperative because constipation can affect the quality of PD dialysate
flow and result in an unwanted effect on the dialysis adequacy.
There is limited data on how to best manage constipation in the peritoneal dialysis
population. Polyethylene glycol (PEG) is an osmotic laxative that is becoming popular for
prevention and treatment of constipation across Canada. Although some PD programs in Canada
have already converted to PEG for management of constipation, more research in this
population would help guide practice. For now, the current PD bowel regimen at the Nova
Scotia Health Authority (NSHA) includes daily preventative therapy using a stimulant
laxative, senna, along with an osmotic laxative, lactulose, for acute constipation.
The investigators will review all patients in the NSHA PD program who have regular or recent
laxative use for participation in this study. Patients included in this study will be
randomly assigned to the Current Bowel Protocol or the PEG Bowel Protocol for 8 weeks.
The goal is to determine if the PEG Bowel Protocol is as effective and safe for the
prevention of constipation as the Current Bowel Protocol used in the PD Program. The
investigators will use bowel function diaries and patient surveys to determine efficacy and
safety outcomes.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | February 1, 2018 |
Est. primary completion date | November 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All patients in the peritoneal dialysis program in Nova Scotia who are currently taking laxatives. Exclusion Criteria: - Allergy or intolerance to any of the study laxatives (PEG, senna, lactulose); cognitive impairment or inability to document symptoms; known or suspected gastrointestinal obstruction or ileus; known or planned pregnancy; no laxative use in the last 3 months. |
Country | Name | City | State |
---|---|---|---|
Canada | Queen Elizabeth Health Sciences Centre | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Jaclyn Tran |
Canada,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of constipation treatment success | Successful treatment of constipation will be defined based on a modified ROME criteria developed by Dipalma 2007: relief of constipation for more than 50% of the weeks in the study. | 8 weeks. | |
Secondary | Number of patients with laxative related adverse effects. | Compare the occurrence of side effects during the study period. | 8 weeks. | |
Secondary | Mean change from baseline on the PAC-SYM questionnaire | Measure of the impact of constipation disease severity. PAC-SYM = Patient Assessment of Constipation Symptoms (Frank 1999 and Bove 2012) | 8 weeks. | |
Secondary | Mean change from baseline on the PAC-QOL questionnaire | Measure the impact of constipation on quality of life. PAC-QOL = Patient Assessment of Constipation Quality of Life (Marquis 2005 and Bove 2012) | 8 weeks | |
Secondary | Incidence of peritoneal dialysis treatment failure requiring intervention | Interventions include antibiotics for peritonitis, catheter re-positioning. | 8 weeks |
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