Prospective observational single arm study evaluating Polyethylene glycol plus Bisacodyl for managing constipation in patients with advanced cancers under specialist palliative care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Frequency as percentage of responders
研究概览
简要总结
Constipation is a common and distressing problem for patients with advanced cancer, often leading to discomfort and reduced quality of life. Many factors contribute to constipation in these patients, including reduced mobility, inadequate fluid intake, and the use of pain-relieving opioids. Despite various treatment options available, managing constipation effectively remains challenging.
This study aims to evaluate the effectiveness of a combination of two commonly used laxatives like Polyethylene Glycol ie PEG and Bisacodyl—in relieving constipation among patients receiving palliative care. PEG helps retain water in the intestines, softening stools, while Bisacodyl stimulates bowel movements.
The study will be conducted at the Tata Memorial Hospital’s Palliative Medicine Outpatient Department in Mumbai. It is a prospective observational study, meaning researchers will monitor and analyze patients’ responses to this treatment without altering standard medical care. Patients who meet the eligibility criteria and consent to participate will receive the PEG + Bisacodyl combination, and their bowel movements and symptom relief will be assessed after 48 hours.
The primary goal is to determine the percentage of patients who have a bowel movement within 48 hours of starting the laxative.
Secondary objectives include assessing changes in constipation severity, patient-reported side effects, and adherence to the prescribed laxative regimen.
The findings from this study will help improve constipation management in palliative care settings, ensuring better comfort and quality of life for patients with advanced cancer.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 18 years or more and willing to participate 2.Referred to Department of Palliative Medicine with constipation more than or equal to 3 out of 10 in numerical rating score NOT on T Bisacodyl 5mg tablet + syrup PEG 20ml in 200ml water.
- •3.Able to communicate and understand English/Hindi/Marathi 4.Able to give written informed consent for questionnaire administration 5.Diagnosed case of advanced malignancy.
排除标准
- •1.Unstable medical condition requiring emergency treatment 2.Pre-existing Psychiatric disorder or cognitive impairment preventing patients from comprehending questionnaire 3.Known or suspected bowel obstruction or ileus 4.Presence of a colostomy or ileostomy 5.History of inflammatory bowel disease 6.Colorectal Primary Site of Cancer 7.Contraindication to any of the medication used Eg.Patients on Parenteral Hydration and nutrition only.
结局指标
主要结局
Frequency as percentage of responders
时间窗: Baseline and 48 hours
(Responders will be defined as having passed any bowel movement in 48 hours following initiation of laxative)
时间窗: Baseline and 48 hours
次要结局
- 1)To evaluate change in numerical rating score for constipation in Edmonton Symptom Assessment System- Revised –CS at 48 hours after initiation of laxative(2) To evaluate patient reported adverse effects at 48 hours)