Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation: A Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- the proportion of patients having successful disimpaction
研究概览
简要总结
Fecal impaction (FI) is a common cause of lower gastrointestinal tract obstruction, and it is the result of chronic or severe constipation and most commonly found in the elderly population. Gastrografin is a water soluble contrast mediate that could act as an osmotic laxative. It has been shown to confer a therapeutic benefit in adhesive small bowel obstruction (SBO). The investigators speculate that gastrografin administrated orally may be more effective than enema in the treatment of fecal impaction induced intestinal obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed presence of fecal impaction diagnosed based on the following conditions: large amount of hard stool (impacted faecaloma) in colon or rectum; abdominal radiography was performed for assessment.
- •Rome III criteria for chronic constipation present for ≥8 weeks.
排除标准
- •Patients with a history of colorectal surgery or an organic cause of constipation; pregnancy.
- •Patients with long-term medical conditions potentially associated with constipation (ie, cystic fibrosis, cerebral palsy, hypothyroidism, spinal and gastric anomalies).
- •Patients with medical or psychiatric illness.
- •Patients with abnormal laboratory data or thyroid function.
研究组 & 干预措施
Exposure Group
Participants were allocated to receive 100 mL of Gastrografin orally once daily for 6 consecutive days.
干预措施: Gastrografin (Drug)
Control Group
Participants were allocated to receive enemas twice daily for 6 consecutive days.
干预措施: enemas (Procedure)
结局指标
主要结局
the proportion of patients having successful disimpaction
时间窗: 6 days
Successful disimpaction was indicated by the passage of watery stools.
the time when patients having successful disimpaction
时间窗: 6 days
Successful disimpaction was indicated by the passage of watery stools.
次要结局
- Wexner constipation score(6 days)
- Patient Assessment of Constipation-Symptoms (PAC-SYM) score(6 days)
- Patient Assessment of Constipation Quality of Life (PAC-QOL) score(6 days)
- adverse events and safety(6 days)
研究者
Jianfeng Gong
Associate professor
Jinling Hospital, China