Bowel Preparation in Colonoscopy: Lactulose vs Polyethyleneglycol, Randomized Double-blind Comparative Clinical Trial, Multicenter Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 449
- 试验地点
- 3
- 主要终点
- Bowel Cleansing Was Assessed Using the Boston Bowel Preparation Scale (BBPS).
研究概览
简要总结
The goal of this clinical trial it is to bowel the instestinal preparation with lactulose vs poliethylenglicol as better agent to have a quality colonoscopy and demostrate that lactulose is most efective, has a good tolerance and the patient would have a better satisfaction, so the question is:
wich is the eficancy of lactulose in comparision with thepoliethylenglycol in the intestinal preparation for the colonoscopy?
详细描述
A bowel preparation is fundamental before making a colonoscopy, letting us realize a correct exploration in all the bowel. The main method of cleaning would be fast, safe and getting a high grade of visualizing to do a quality colonoscopy.
Actually there are a lot of methods or products of cleaning the bowel. A good cleaning have a lot of successful choosing a good product to do it and having a good diet before the colonoscopy.
There are a lot of scales about the cleaning in the colonoscopy, having a good bowel preparation increase the capacity of the detection of polyps, decrease the time of the colonoscopy and getting better the cost and efficiency.
The colonoscopy plays a crucial role in the screening and treatment of colorectal cancer. It is an optimal procedure to identify precancerous lesions. polyps and recommended for screening people with risk factors, such as a family history of polyps or cancer.
Bowel preparation is a crucial aspect in colonoscopy due to its direct relationship with the quality of the procedure. Many patients find bowel preparation to be the most uncomfortable part of the examination, so ensuring that it is safe, extremely efficient, reliable, convenient and tolerable enough to ensure that patients will not be able to complete it or wish to undergo future procedures, associating this with the bad taste of the agents used and the adverse events produced.
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 (Care Provider)
盲法说明
The main investigators will be in charge of randomizing all the patients ellegible for this protocol, and the care providers and endoscopists will be masked when it comes to knowing to which arm of the study each patient belongs to, untill the moment they need to perform the colonoscopy.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Patients with indication for colonoscopy in our coloproctology service
- •Both women and men
- •Patients within an age range of 18-79 years
- •Patients who agree having a colonoscopy and who sign the informed consent to participate in the protocol
排除标准
- •Patients under 18 or over 80 years old
- •All patients that won´t like to participate in the protocol or won´t sign the informed consent
- •Pregnant women
- •Patients with a medical record of colonic resection, ostomy status, severe cardiopulmonary and renal diseases, major psychiatric disorders, therapeutic colonoscopy or any contraindications for colonoscopy
- •Non compliance with the colonic preparation regimen
- •Active bleeding during the procedure
- •Patients with a known diagnosis of colorectal cancer
研究组 & 干预措施
Bowel preparation with lactulose before de colonoscopy
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
干预措施: Bowel preparation before colonoscopy (Combination Product)
Bowel preparation with plyethylenglycol before the colonoscopy
Patients will be randomized and assigned the bowel preparation the day that provide them the day of the colonoscopy
干预措施: Bowel preparation before colonoscopy (Combination Product)
结局指标
主要结局
Bowel Cleansing Was Assessed Using the Boston Bowel Preparation Scale (BBPS).
时间窗: The duration of the study (approximately 20 to 30 minutes).
Bowel cleansing quality was assessed using the Boston Bowel Preparation Scale (BBPS), which evaluates three segments of the colon (right, transverse, and left), each scored from 0 to 3, with a total score ranging from 0 to 9. Higher scores indicate better bowel preparation.
次要结局
- Number of Participants With Gastrointestinal Side Effects(At the completion of bowel preparation, prior to colonoscopy (approximately 8 hours before the procedure).)
- Number of Participants Who Tolerated the Assigned Bowel Preparation(24 hours before your colonoscopy)
- Number of Participants Who Found the Bowel Preparation Palatable(24 hours before the colonoscopy while taking the assigned bowel preparation)
研究者
Roberto Ulises Cruz Neri
M. C. Roberto Cruz Neri (Master in cience, medical staff Coloproctology Department Hospital Civil Fray Antonio Alcalde)
Hospital Civil de Guadalajara