Sennosid A+B Versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation; A Prospective Randomized Observer-Blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Sennosid A+B versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation: A Prospective Randomized Observer-Blinded Study
研究概览
简要总结
Colonoscopy Preparation: Comparing Sennoside A+B and PM/Ca
Colonoscopy is a test used to examine the inside of the bowel. Proper bowel preparation is crucial because it helps doctors get a clear view during the procedure.
What is Sennoside A+B? Sennoside A+B is a type of laxative made from the senna plant. It works by stimulating the bowel to move and reducing the absorption of water, making it easier to pass stools. Research has shown that high doses of sennoside A+B can be effective for bowel preparation.
Sennoside A+B vs. PEG:
Some studies have found that sennoside A+B is more effective than PEG, another laxative, but can cause more abdominal pain. Other studies have found no significant difference in effectiveness between the two.
What is Picosulfate/Magnesium Oxide/Citric Acid (PM/Ca)? PM/Ca is a combination of sodium picosulfate, magnesium oxide, and citric acid. Sodium picosulfate stimulates bowel movements, while magnesium oxide and citric acid help increase water in the bowel, making it easier to pass stools.
PM/Ca vs. PEG:
Research has shown that PM/Ca is as effective as PEG for bowel preparation. Patients using PM/Ca generally tolerate the preparation process better than those using PEG.
Conclusion:
While PEG is the preferred option according to guidelines, its high cost can make it less accessible in some places. In this study, we aim to compare the effectiveness and patient tolerance of Sennoside A+B and PM/Ca since no direct comparison between these two preparations has been made before.
详细描述
Colonoscopy is an endoscopic imaging method used to examine the lumen and mucosa of the bowel. It is the gold standard method used for colorectal cancer screening and the detection of most colorectal pathologies. Successful bowel preparation is one of the key factors for a successful colonoscopic examination.
Sennoside A+B is a stimulant laxative derived from the senna plant (Cassia senna). Studies have shown that after senna is ingested, it is activated by the gut flora, directly interacts with the intestinal mucosa, stimulates bowel movements, and inhibits the absorption of electrolytes and water. High doses of senna have been shown to be beneficial as a bowel preparation agent.
There are many studies in the literature comparing senna compounds with polyethylene glycol (PEG) solutions. In a randomized controlled study conducted by Coskun et al. on 474 patients, it was found that bowel cleansing was better with sennoside A+B compared to PEG, but abdominal pain was more common in the senna group. Another randomized controlled study conducted by Shavakhi et al. on 322 patients found no difference in effectiveness between the two agents.
Drugs containing sodium picosulfate-magnesium oxide-citric acid (PM/Ca) are laxative agents recommended for colonoscopy preparation in ESGE and ASGE guidelines. While sodium picosulfate acts as a stimulant laxative, magnesium oxide and citric acid act as osmotic laxatives.
In the SEE CLEAR II randomized controlled trial comparing PM/Ca with PEG, PM/Ca was found to be as effective as PEG. No significant difference was found between the two groups in terms of side effects, but participants using PM/Ca tolerated the bowel preparation procedure much better.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years scheduled for elective outpatient colonoscopy.
- •Ability to provide informed consent.
排除标准
- •History of intra-abdominal surgery.
- •Chronic kidney failure.
- •Congestive heart failure.
- •Chronic liver failure.
- •Inflammatory bowel disease.
- •Electrolyte imbalance.
- •Hospitalized patients.
- •Patients unable to use the bowel preparation treatment
- •Known allergy or hypersensitivity to Sennoside A+B or PM/Ca components
- •Known gastrointestinal motility disorders.
研究组 & 干预措施
"Sennoside A+B Group" for bowel preparation.
This study will compare two bowel preparation methods in patients undergoing colonoscopy:
Sennoside A+B Group
Intervention: Patients will take Sennoside A+B, a stimulant laxative derived from the senna plant.
Purpose: To cleanse the colon by increasing bowel movements and reducing water absorption.
干预措施: Sennosid A+B (Drug)
"PM/Ca Group" for bowel preparation.
PM/Ca Group (Sodium Picosulfate/Magnesium Oxide/Citric Acid)
Intervention: Patients will take a combination of sodium picosulfate (a stimulant laxative) and magnesium oxide/citric acid (osmotic agents).
Purpose: To promote bowel movements by stimulating the bowel and drawing water into the colon.
干预措施: Sodium Picosulfate/Magnesium Oxide/Citric Acid (Drug)
结局指标
主要结局
Sennosid A+B versus Sodium Picosulfate/Magnesium Oxide/Citric Acid for Bowel Preparation: A Prospective Randomized Observer-Blinded Study
时间窗: 4 months
Effectiveness of bowel preparation using the Boston Bowel Preparation Scale (BBPS). The BBPS is a standardized 9-point assessment scale for the colon. The structure of the colon is divided into its three segments: right colon, transverse colon, and left colon. Each segment is classified from 0 to 3 depending on the degree of soiling. The sum total of the three segments represents the degree of soiling, so that a total ≤ 5 points shows poor bowel preparation, while 6-7 shows good bowel preparation, and ≥ 8 very good bowel preparation. The investigators will consider patients with a score of 6 or higher as successful.
次要结局
未报告次要终点
研究者
İbrahim Durak
Medical Doctor
Hitit University