ColonoscopyNCT06111937
Time Interval After Gastric Emptying and Quality of Bowel Cleansing
A study testing after ultrasound gastric assessment to ensure gastric empty, painless colonoscopy was performed within 2 hours in people with Colonoscopy, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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]. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- after ultrasound gastric assessment to ensure gastric empty, painless colonoscopy was performed within 2 hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.Patients who receiving elective colonoscopy under general anesthesia
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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].
Read the detailed 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.
- Conditions
- Colonoscopy
- Being tested
- after ultrasound gastric assessment to ensure gastric empty, painless colonoscopy was performed within 2 hours
- Keywords
- Colonoscopy, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
after ultrasound gastric assessment to ensure gastric empty, painless colonoscopy was performed within 2 hoursOther
Also called Ultrasound gastric assessment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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". |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: five minutes after finishing colonoscopy examination
full stomach rate after finishing MgSO4 solution under different waiting time
recording full stomach rate using gastric ultrasound
Measured: 2 or 4 hours after finishing taking MgSO4 solution
Secondary outcomes (2)
The rate of ileum intubation while performing colonoscopy
recording rate of ileum intubation
Measured: while performing colonoscopy
the detection rate of polyp and adenoma while performing colonoscopy
recording the detection rate of polyp and adenoma
Measured: while performing colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Nov 2023
- Primary completion30 Jun 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gu JianPing, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111937
- Sponsor's protocol ID
- KY20230428-01
- Status last verified
- Mar 2024
- First submitted
- 21 Sep 2023
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29391311Tooson 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.
PubMed 8700818Van 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.
PubMed 24893784
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06111937
- Acronym / sponsor ID
- KY20230428-01
- Conditions
- Colonoscopy
- Keywords
- Colonoscopy, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colonoscopy within 2-4 h | Experimental | Other: after ultrasound gastric assessment to ensure gastric empty, painless colonoscopy was performed within 2 hoursPatients 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. |
| 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". |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Patients who receiving elective colonoscopy under general anesthesia
Key exclusion criteria (4 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| after ultrasound gastric assessment to ensure gastric empty, painless colonoscopy was performed within 2 hoursAlso: Ultrasound gastric assessmentPatients 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. | Other | colonoscopy within 2-4 h |
Primary outcome
Boston bowel preparation quality scale
Time frame: five minutes after finishing colonoscopy examination
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.
full stomach rate after finishing MgSO4 solution under different waiting time
Time frame: 2 or 4 hours after finishing taking MgSO4 solution
recording full stomach rate using gastric ultrasound
2 secondary outcomes
The rate of ileum intubation while performing colonoscopy
Time frame: while performing colonoscopy
the detection rate of polyp and adenoma while performing colonoscopy
Time frame: while performing colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 29391311Lee 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.
- Results publication: PubMed 8700818Tooson 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.
- Results publication: PubMed 24893784Van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gu JianPing study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing after ultrasound gastric assessment to ensure gastric empty, painless colonoscopy was performed within 2 hours in people with Colonoscopy, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston bowel preparation quality scale (time frame: five minutes after finishing colonoscopy examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06111937, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.