ClinicalTrials.gg
Status unknownNCT03306030Updated Nov 28, 2017

Comparison of Two Methods for Bowel Preparation in Patients With Constipation

An interventional study of Split dose of 4L PEG and Three times dose of 4L PEG in Health Behavior, sponsored by Air Force Military Medical University, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 28 studies in Health Behavior with a site in China — 12 open to participants now, 14 under way, none of them phase 3. Health Behavior · China.

Planned enrollment
9th of 19
140 · median 136
Started
2017
with 1 other
No phase
18 of 28
7 open now
Registered
7th of 28
by date
Lead sponsor
2 of 28
Air Force Military Medical University, China

Among the 28 studies in Health Behavior with a site in China, this one is the 9th largest by planned enrollment of the 19 interventional ones that give a count, is one of 2 that started in 2017, is one of 18 with no phase, and was the 7th registered.

Health Behavior

968 studies on the registry are indexed under Health Behavior; 166 are open to participants now.

Browse Health Behavior studies →

Open to participants now

12 of the 28 studies in Health Behavior with a site in China are open now. Recruiting first, the newest first:

7 more — sign in →

All 12 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 93 Health Behavior studies recruiting now, 39 (42%) set no upper age limit and 37 (40%) stop at 75 or younger; 25 take children under 18; 58 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study summary

Constipation is a common high risk factor for inadequate bowel preparation. The bowel cleansing efficacy of the standard split-does of 4L seems to be suboptimal in constipated patients. The investigator hypothesized that compared with the standard preparation regime, the split-dose with three times of 4L PEG may be superior in BP quality.

03

Conditions studied

  • Health Behavior

Browse trials for

Keywords

  • PEG
  • Bowel preparation
  • Colonoscopy
  • split-does
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18-80 with constipation.

Exclusion criteria

Exclusion Criteria:

  • History of colorectal surgery >30 Suspected colonic stricture or bowel obstruction Use of purgatives within 3 days Pregnancy or lactation Unable to give Haemodynamically unstable
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
140 participants (estimated)

Study arms

  • Active comparator
    Split group

    Split-dose of 4l PEG was used before and on the day of colonoscopy

    Drug: Split dose of 4L PEG

  • Experimental
    Three times group

    Three times-dose of 4l PEG was used before and on the day of colonoscop of 4l PEG was used before and on the day of colonoscopy

    Drug: Three times dose of 4L PEG

Interventions

  • DrugSplit dose of 4L PEG

    All patients were given oral instruction for bowel preparation on the day of appointment and re-instruction through phone call on two days before scheduled colonoscopy. They were instructed to have a regular lunch and take only clear liquid or low-residual food for the dinner on the day before colonoscopy. The participants began to drink the first 2 L of PEG at 7:00-9 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.

  • DrugThree times dose of 4L PEG

    The same as mentioned above. The participants began to drink the first 1.5 L of PEG at 2:00 PM and the second 1.5L of PEG at 8:00PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients take the remaining 1.0 L 4-6 hours before colonoscopy.

06

What researchers measure

Primary outcomes

  1. Rate of adequate bowel preparation

    Adequacy of bowel preparation quality was defined as a total score ≥6 and each segmental score ≥2. The total scores included 3 scores of colonic regions: the right side, the transverse section, and the left side, which ranged from 0 to 9 (0= very poor, 9=excellent). For the unreached colon in incomplete colonoscopy, the segmental BBPS was scored as 0. The total and segmental scores were judged through videos by investigators who were familiar with the criteria and blinded to group allocation.

    Time frame: 1 year

Secondary outcomes

  1. Adverse event rate

    Time frame: 1 year

  2. Cecal intubation rate

    Time frame: 1 year

  3. Cecal intubation time

    Time frame: 1 year

  4. Withdrawal time

    Time frame: 1 year

  5. Polyps detection rate

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Endoscopic center, Xijing Hospital of Digestive Diseases
    Xi'an, 710032, China
    Recruiting
    • Hui Jia, MD · Contactjiahuifmmu@163.com · +862984771536
    • Yanglin Pan, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2017 (actual). Primary completion is estimated for Aug 2018, 11 months after the start.

Of 568 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's planned 11 months is below that.

Counting every sponsor, half of 586 studies reached it within 15 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2017
First posted
Oct 10, 2017
StartActual
Sep 1, 2017
Primary completionEst.
Aug 31, 2018
CompletionEst.
Nov 30, 2018
Last update
Nov 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03306030
Responsible party
Yanglin Pan (Associated professor, Air Force Military Medical University, China) — Principal investigator
First posted
Oct 10, 2017
Start date
Sep 1, 2017
Primary completion
Aug 31, 2018 (estimated)
Completion
Nov 30, 2018 (estimated)
Last update
Nov 28, 2017

Study contacts

Hui Jia
Contact
jiahuifmmu@163.com
+862984771536

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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