跳至主要内容
临床试验/NCT06021639
NCT06021639已完成不适用

Comparison of 1-day Clear Liquid Diet and Low-fiber Diet in Bowel Preparation for Colonoscopy

Mersin University2 个研究点 分布在 2 个国家目标入组 144 人开始时间: 2023年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
144
试验地点
2
主要终点
Cleaning during colonoscopy

研究概览

简要总结

Colonoscopy is a frequently used method in colon cancer screening today. Routine bowel cleansing is performed for colonoscopy. When the guidelines are examined, there are various recommendations regarding colonoscopy preparation regimens and durations. In this study, participants using the same colon cleansing drug before colonoscopy will be compared in terms of colon cleansing of the patient group who had a clear diet in the last 24 hours before the procedure and the patient group who had a low fiber diet.

详细描述

Studies have reported that inadequate bowel preparation reduces the detection of polyps that may have the potential to become cancerous. Unfortunately, however, many participants are unable to comply with bowel cleansing regimens due to strict dietary changes and large amounts of unpleasant laxative solutions that affect their quality of life before the procedure. In addition, participants with insufficient bowel cleansing should repeat similar preparation steps before the next examination. The European Society for Gastrointestinal Endoscopy (ESGE) recommends a polyethylene glycol (PEG) regimen for colonoscopy preparation and low-fiber food intake 24 hours prior to the procedure. In our country, PEG is not used routinely and frequently in terms of cost and lack of SGK payments. 'Sennoside A+B calcium', which is used for colonoscopy preparation in our country, shows its effect by increasing intestinal motility and causes the accumulation of water and electrolytes in the colon lumen. It has security and ease of application. In addition, the fact that it is paid by the Social Security Institution and the price is affordable makes it advantageous in the preparation of colonoscopy. Although there is not enough data for colonoscopy preparation in our country, each clinic determines the duration of the regimen in various ways. The aim of this study is to compare the patient group who used low fiber food for 24 hours before colonoscopy and who had a clear diet for 24 hours before colonoscopy in terms of adequate cleaning during endoscopy in participants who underwent bowel cleansing with 'Sennoside A+B calcium'.

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
Single (Investigator)

盲法说明

Randomization will be planned 1 to 1 according to the order of application. Randomization will be planned by the endoscopy nurse in the endoscopy unit and will not be known to the endoscopist who will perform the procedure.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18 years and older
  • Patients undergoing colonoscopy for colorectal cancer screening, or patients with nonspecific gastrointestinal symptoms

排除标准

  • Patients with a serious medical condition such as severe heart
  • Kidney or metabolic disease
  • Psychiatric disease not complying with the recommended regimen
  • Patients with a history of colon resection for any reason
  • Patients with suspected intestinal obstruction or ileus
  • Patients undergoing emergency colonoscopy
  • Patients who did not accept the informed consent form.

研究组 & 干预措施

Low fiber diet group

Experimental

250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. He/she will consume low fiber food in the last 24 hours.

干预措施: The last 24 hours will consume low fiber food. (Dietary Supplement)

Clear diet group

No Intervention

250 ml Sennozit A+B calcium (half dose is taken orally at 17.00 on the day before the procedure and the other half at 19.00 will be consumed. Enema 210 cc (Monobasic sodium phosphate 28.5 g. Dibasic sodium phosphate 10.5 g.) The procedure is rectal at 07.00 in the morning. will be used as Routine feeding of the patient up to the last 24 hours before the procedure. The last 24 hours will consume clear diet.

结局指标

主要结局

Cleaning during colonoscopy

时间窗: During the colonoscopy procedure

The quality of cleaning for each segment of the colon was rated ac- cording to the Boston Bowel Preparation Scale (BBPS) as follows: Score 0 (mucosa not visible due to solid stool, or thick liquid stool cannot be cleared); Score 1 (areas of the colon segment not seen well due to staining, resid- ual stool, and/or opaque liquid); Score 2 (minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa seen well); and Score 3 (en- tire mucosa of the colon segment seen well). The left colon, transverse colon, and right colon segments were scored separately, and then these segment scores were summed for a total BBPS score ranging from 0 to 9. Categorical assessment for each possible total BBPS score: "excellent," 8-9; "good," 6-7; "fair," 5; "poor," 3-4; or "unsatisfactory," 0-2

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilmi Bozkurt

Associate Professor

Mersin University

研究点 (2)

Loading locations...

相似试验