Colonoscopy Clinical Trial
Official title:
Correlation Between Time Interval After Gastric Emptying With Ultrasound Assessment and Quality of Bowel Cleansing in Patients Undergoing Painless Colonoscopy: a Randomized, Prospective, Controlled Trial
The goal of this [clinical trial] is to [explore the balance time point between the waiting time for intestinal preparation after gastric emptying and quality of bowel preparation.] in [patients with painless colonoscopy]. The main question[s] it aims to answer are: [whether the gastric is empty or not 2 hours after finishing drinking 1.5 L of MgSO4 solution within 2 hours] [whether the quality of patients' bowel preparation is superior in a time period of 2-4 hours after finishing drinking 1.5 L of MgSO4 solution] Participants will [ be asked finishing the last dose of 1.5 L MgSO4 solution within 2 hours and received ultrasound gastric assessment immediately 2 or 4 hours after finishing drinking MgSO4 solution in a 15 minutes time interval until the gastric is empty. As soon as the gastric is empty, patients receive painless colonoscopy within 2 hours or 2-4 hours. Researchers will compare [patients receiving painless colonoscopy within 2 hours or 2-4 hours after finishing drinking 1.5 L of MgSO4 solution] to see if [the quality of patients' bowel preparation is superior in a time period of within 2 hours].
Status | Recruiting |
Enrollment | 148 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1.Patients who receiving elective colonoscopy under general anesthesia Exclusion Criteria: 1. Patients with severe heart and lung diseases who cannot tolerate anesthesia or colonoscopy 2. chronic constipation 3. history of gastric or intestinal surgery 4. diabetes, Parkinson's disease, stroke, |
Country | Name | City | State |
---|---|---|---|
China | Nanjing First Hospital | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing First Hospital, Nanjing Medical University |
China,
Lee J, Kim TO, Seo JW, Choi JH, Heo NY, Park J, Park SH, Yang SY, Moon YS. Shorter waiting times from education to colonoscopy can improve the quality of bowel preparation: A randomized controlled trial. Turk J Gastroenterol. 2018 Jan;29(1):75-81. doi: 10 — View Citation
Tooson JD, Gates LK Jr. Bowel preparation before colonoscopy. Choosing the best lavage regimen. Postgrad Med. 1996 Aug;100(2):203-4, 207-12, 214. doi: 10.3810/pgm.1996.08.59. — View Citation
Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Boston bowel preparation quality scale | Using Boston bowel preparation quality scale: 3 score, the intestinal cleaning range is more than 90%, no fecal residue, clear vision, or only some clear liquid exists; 2 score, The intestinal cleaning range was 75% to 90%, only a small amount of intestinal residue or fecal water remained, which had no effect on the examination and observation; 1 score,fecal residue or fecal water exists in more intestinal segments, and can continue to enter the lens after rinsing with water; 0 score: There are more fecal residues in the intestinal cavity, and it is impossible to continue the examination. According to the above scoring criteria, the intestinal cleanliness of the left colon, transverse colon and right colon were scored respectively. The total score =6 was considered to be good intestinal preparation. The total score < 6 points was considered that the intestinal preparation was poor. | five minutes after finishing colonoscopy examination | |
Primary | full stomach rate after finishing MgSO4 solution under different waiting time | recording full stomach rate using gastric ultrasound | 2 or 4 hours after finishing taking MgSO4 solution | |
Secondary | The rate of ileum intubation while performing colonoscopy | recording rate of ileum intubation | while performing colonoscopy | |
Secondary | the detection rate of polyp and adenoma while performing colonoscopy | recording the detection rate of polyp and adenoma | while performing colonoscopy |
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