Time Interval After Gastric Emptying and Quality of Bowel Cleansing

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111937
• Other study ID #: KY20230428-01
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Shan Tao
• Phone: +8618852095135
• Email: 858727933[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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].

Description:

All subjects ate a light diet the day before the examination and fasted after 19:00 on the night before examination. A segmented intestinal cleansing regimen of 3L MgSO4 was adopted: 1.5L was taken one night before the examination; On the day of the examination, the second dose of 1.5L was taken and finished within 2 hours. The medication method was guided by professional nursing staff. All subjects were instructed to take appropriate activities during the administration of intestinal cleanser to promote excretion. Patients were divided into two groups (group A and group B) using random number table method. Patients in group A received gastric ultrasound examination every 15 minutes 2 hours immediately after taking the last dose of MgSO4 solution. During this period, if the gastric ultrasound showed that the patient had an "empty stomach", and painless colonoscopy was performed within 2 hours while the gastric is empty. If the gastric ultrasound still showed "full stomach" at 4h, the patient was abandoned, but gastric ultrasound assessment continued until the stomach was empty. The patients in group B received gastric ultrasound examination every 15min 4h immediately after taking the last dose of MgSO4 solution on the examination day, and colonoscopy was to completed within 4-6h after taking the MgSO4 solution if the gastric ultrasound showed that the patient had an "empty stomach". If the gastric ultrasound still shows "full stomach" at 6h, it is eliminated, but continuing to perform gastric ultrasound every 15min until the " stomach was empty ". All patients received general anesthesia by the same senior anesthesiologist using propofol 2 mg/kg and remifentanil 0.2 ug/kg. The BIS value of anesthesia depth was controlled in the range of 40-60, and propofol and remifentanil were added as needed. The same chief gastroenterologist performed the colonoscopy and evaluated the quality of intestinal cleaning.

Recruitment information / eligibility

• 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,

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Other:
• after ultrasound gastric assessment to ensure gastric empty, painless colonoscopy was performed within 2 hours
Patients received gastric ultrasound examination every 15 minutes 2 or 4 hours immediately after taking the last dose of MgSO4 solution in group A or B respectively.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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

Outcome

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