Comparison of Colon Preparation With 2-Litre Polyethylene Glycol (PEG) Split-dose in Combination With Lubiprostone Versus 4-Litre Polyethylene Glycol (PEG) Split-dose: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- the degree of colon cleansing
研究概览
简要总结
Colonoscopy is the current standard method for examination of the colon. Bowel cleansing prior to colonoscopy is the essential prerequisite to ensure complete mucosal visualization and lesion identification.(1,2) Suboptimal preparations are associated with missed diagnoses, longer procedure times and increased costs related to the repeat procedures and shortened intervals between procedures.(3-5) Inadequate preparations have been noted in around 25 % cases in the US.(4,6) This has been attributed primarily to poor patient tolerance to the standard colon preparations.
Osmotically balanced polyethylene glycol (PEG) electrolyte bowel lavage solutions were introduced in 1980.(7) These PEG based solutions are the most commonly used bowel preparations today.(7) They have high efficacy, are safe and are associated with minimal fluid and electrolyte imbalance. However the major drawback of these preparations is the taste and the large volumes required with associated nausea, cramping and vomiting.(8) This often results in poor compliance and tolerance with resultant poor preparation and improper visualization. A pooled analysis of 15 trials found that at least 29 % of patients were unable to complete their PEG solution.(9) Lubiprostone (LB) is a locally acting selective Type 2 chloride channel activator which causes intestinal fluid secretion. This results in increased softened stool and increased intestinal transit without the loss of either net intravascular fluid or electrolytes.(10) Peak plasma levels occur approximately 1.14 h after oral administration of a single 24 microgram dose, and the half-life of lubiprostone (t½) has been estimated at approximately 3 h.(11,12) LB is currently approved for the treatment of chronic idiopathic constipation and is generally well tolerated with an excellent side effect profile. Even long term usage has not shown clinically significant changes in electrolyte levels.(10,13) Our hypothesis was that administration of LB in addition to low volume (2-L) split-dose PEG would improve the adequacy of the bowel preparation as comparable as standard 4-L split-dose PEG regimens. Additionally, it could improve patient tolerability and decreased side effects related to the large volume of PEG regimens. Accordingly, we conducted this prospective, single-blind, randomized controlled trial.
详细描述
Study design:
This was a single center prospective, single-blind, randomized controlled trial to compare the quality of bowel preparation using 2-L PEG with LB vs. 4-L PEG conducted from September 2019 to June 2020 at Department of Medicine, Rajavithi Hospital, a tertiary referral center in Bangkok, Thailand. It was performed in accordance with the clinical principles laid down in the Declaration of Helsinki and informed consent was obtained from all the participants before their enrollment. The study protocol was reviewed and approved by the ethics committee of Rajavithi Hospital. Recruitment, enrollment, randomization, withdrawal, and completion were done according to the consort guidelines.
Bowel preparation method:
PEG used in the present study was Niflec® (Meiji, Japan), which composed of macrogol 4,000 plus electrolytes (sodium sulfate, sodium hydrogen carbonate, sodium chloride, and potassium chloride) and is taken by diluting one sachet into 2-L of plain water. The participants were instructed to take 250 mL every 15 min untill the entire solution was consumed. In cases of 4-L split-dosage, half dose preparation started in the evening of the pre-procedure day at about 8.00 to 10.00 pm and the remaining dose was given in the morning at about 5.00 to 7.00 am on the procedure day. In cases of 2-L split-dosage, half dose preparation started in the evening of the pre-procedure day at about 8.00 to 9.00 pm and the remaining dose was given in the morning at about 5.00 to 6.00 am on the procedure day. And these patients, one 24 mcg tablet of LB was given 2 hours before PEG ingestion (at 6.00 pm of the pre-procedure day).
Dietary advice was given to all patients. Consumption of fruit, legumes, or vegetable was forbidden 2 days before the procedure. On the day before colonoscopy patients had a light breakfast and lunch, but a liquid dinner (clear soup). Solid food was not allowed at the start of the bowel preparation phase. All patients were instructed to fast from midnight before procedure day, but some anti-hypertensive drugs and minimal plain water were permitted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Gastroenterologists and investigators were blinded to the allocation groups.
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
- •All patients between the age of 18 and 75 years with an appropriate indication for elective colonoscopy were considered eligible.
排除标准
- •We excluded patients who (i) suspected gastroparesis, gastric outlet or bowel obstruction; (ii) had a previous history of any gastrointestinal surgery apart from an appendectomy and cholecystectomy; (iii) had severe cardiac or pulmonary disease (American Society of Anesthesiologists physical status class 3 or 4), severe renal failure (creatinine clearance <30 mL/min), decompensated liver cirrhosis or severe systemic illness; (iv) had a compromised swallowing reflex or impaired mental status; (v) were in a state of pregnancy or lactating; (vi) were hypersensitive or allergic to PEG or LB; or (vii) had a history of previous failure of adequate bowel preparation for colonoscopy.
研究组 & 干预措施
2-L PEG with LB
PEG used in the present study was Niflec® (Meiji, Japan), which composed of macrogol 4,000 plus electrolytes (sodium sulfate, sodium hydrogen carbonate, sodium chloride, and potassium chloride) and is taken by diluting one sachet into 2-L of plain water. The patients were instructed to take 250 mL every 15 min untill the entire solution was consumed.
In this group (2-L PEG), half dose preparation started in the evening of the pre-procedure day at about 8.00 to 9.00 pm and the remaining dose was given in the morning at about 5.00 to 6.00 am on the procedure day. And these patients, one 24 mcg tablet of LB was given 2 hours before PEG ingestion (at 6.00 pm of the pre-procedure day).
干预措施: polyethylene glycol in combination with lubiprostone (Drug)
4-L PEG
In this group (4-L PEG), half dose preparation started in the evening of the pre-procedure day at about 8.00 to 10.00 pm and the remaining dose was given in the morning at about 5.00 to 7.00 am on the procedure day.
干预措施: polyethylene glycol alone (Drug)
结局指标
主要结局
the degree of colon cleansing
时间窗: up to 7 months
We used Boston bowel preparation scale (BBPS) score to evaluate the adequacy of the preparation. Each colonic segment was graded from 0 (solid stools) to 3 (no residual staining). The aggregate score was obtained by adding the score for all 3 segments, thus resulting in a score between 0 and 9. A score ≤4 was considered a poor colon preparation, resulting in a recommendation for a repeat procedure. A score of 8-9 was considered excellent preparation while a score of 5-7 was considered adequate preparation. The colon preparation was graded by analyzing photo documentation obtained during a colonoscopy by three gastroenterologists (AS, KJ, and TC) after the procedure finished. The mean BBPS score of each patient was calculated and recorded the result on a separate standardized form.
次要结局
- patient's tolerability(up to 7 months)
- adverse events related to bowel preparation(up to 7 months)