Time Interval After Gastric Emptying and Quality of Bowel Cleansing

NCT06111937 | Completed

• 1 other identifier: KY20230428-01
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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 \[the quality of patients' bowel preparation is superior in a time period of within 2 hours\].

Conditions

Colonoscopy

Keywords

Colonoscopy; Ultrasound

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• The rate of ileum intubation while performing colonoscopy

  while performing colonoscopy

• the detection rate of polyp and adenoma while performing colonoscopy

  while performing colonoscopy

Study Arms (2)

colonoscopy within 2-4 h

EXPERIMENTAL

Patients received ultrasound gastric assessment every 15 minutes 2 hours immediately after taking the last dose of MgSO4 solution. During this period, if the gastric ultrasound assessment showed that the patient had an "empty stomach", and painless colonoscopy was performed within 2 hours while the gastric is empty.

Other: after ultrasound gastric assessment to ensure gastric empty, painless colonoscopy was performed within 2 hours

colonoscopy within 4-6 h

NO INTERVENTION

The patients received ultrasound gastric assessment 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 assessment showed that the patient had an "empty stomach".

Interventions

after ultrasound gastric assessment to ensure gastric empty, painless colonoscopy was performed within 2 hours OTHER

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.

Also known as: Ultrasound gastric assessment

colonoscopy within 2-4 h

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who receiving elective colonoscopy under general anesthesia

You may not qualify if:

• Patients with severe heart and lung diseases who cannot tolerate anesthesia or colonoscopy
• chronic constipation
• history of gastric or intestinal surgery
• diabetes, Parkinson's disease, stroke,

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related 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: 10.5152/tjg.2018.17467.

  PMID: 29391311 RESULT

• 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.

  PMID: 8700818 RESULT

• 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.

  PMID: 24893784 RESULT

Study Officials

• Gu JianPing

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: November 1, 2023
• Study Start: November 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 19, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)