Acute Lower Gastrointestinal BleedingCANDLENCT06254443
Oral PEG vs. Enema in Urgent Colonoscopy for ALGIB
A study testing Enema Bowel preparation and PEG Bowel preparation in people with Acute Lower Gastrointestinal Bleeding, run by Beijing Friendship Hospital at 3 sites in China.
Trial summary
The main goal of this study is to assess whether the diagnostic efficacy of enema is non-inferior to that of oral polyethylene glycol (PEG) in acute lower gastrointestinal bleeding (ALGIB) patients requiring urgent colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lower Gastrointestinal Bleeding
- What is being tested?
- Enema Bowel preparation and PEG Bowel preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 3 sitesChina
- Study dates
- 8 Jan 2024to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with hematochezia who were admitted to our hospitals were eligible for the study. Patients were included if they met the following criteria:
- Had the last bloody bowel movement within 24 hours of presentation;
- Aged 18 years or over
- Had indications for clinical colonoscopy
Who cannot join
- Known or suspected upper gastrointestinal bleeding meeting any of the following criteria:
- Presence of hematemesis or black vomiting. B. Bloody or coffee nasogastric aspirate. C. Endoscopic evidence of acute upper gastrointestinal bleeding, such as gastric or duodenal ulcer bleeding, esophagogastric variceal bleeding, etc.
- Previous colonoscopy has been performed at an external institution with a confirmed diagnosis.
- Presence of primary or secondary coagulation disorders.
- History of bowel diversion surgery (including partial colon resection).
- Hemodynamic instability persists after fluid resuscitation (shock index greater than 1).
Show all 11Show fewer
- Interventional treatment has been performed and hemostasis has been successfully achieved.
- Requires transfer to an intensive care unit due to the severity of the condition.
- Unable to comply with oral polyethylene glycol administration or enema procedures.
- Known or suspected relative contraindications to colonoscopy, such as toxic megacolon, acute intestinal obstruction, acute myocardial infarction, heart failure, severe liver failure, and end-stage renal disease.
- Pregnant or lactating women.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Friendship Hospital, Capital Medical University
Beijing
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Tongliao City Hospital
Tongliao, Neimenggu
About this study
Official title: Comparison of Oral Polyethylene Glycol and Enema for Diagnostic Efficacy in Urgent Colonoscopy for Acute Lower Gastrointestinal Bleeding: a Multicenter, Randomized, Non-inferiority Trial
The main goal of this study is to assess whether the diagnostic efficacy of enema is non-inferior to that of oral polyethylene glycol (PEG) in acute lower gastrointestinal bleeding (ALGIB) patients requiring urgent colonoscopy. The secondary objectives include: 1) evaluating potential differences between the enema and oral PEG groups in terms of the difficulty and safety of colonoscopy, as well as exacerbation of bleeding; 2) conducting subgroup analyses to compare the effectiveness of the two bowel preparation methods in specific populations, exploring potential candidate groups for different bowel preparation strategies, and promoting individualized diagnosis and treatment for ALGIB.
Read the detailed description
This is a multicenter, prospective, single-blind, randomized controlled, non-inferiority study. The study includes the following steps:
Step 1: Participants will be enrolled based on predefined criteria, and demographic data, fasting water duration, accompanying symptoms, smoking history, alcohol consumption history, antithrombotic drug usage, previous history of lower gastrointestinal bleeding, Charlson comorbidity index, vital signs at admission, and laboratory results at admission will be collected.
Step 2: All participants will undergo stratified block randomization, and based on the randomization results, participants will receive bowel preparation using either PEG or enema. Subsequently, all participants will undergo urgent colonoscopy within 48 hours from admission.
Step 3: Follow-up records will be conducted at the following time points:
- Before colonoscopy:
- Record the specific method and dosage of actual bowel preparation.
- Record changes in vital signs, symptoms, and signs before and after bowel preparation, as well as occurrences of adverse events.
- Conduct a satisfaction survey of bowel preparation.
- During colonoscopy:
- Record patient pain scores, Boston bowel preparation scores, cecal intubation time, lesion detection time, total procedure time, maximum insertion depth, observation of active bleeding, endoscopic diagnosis, endoscopic hemostasis, and perforation.
- After colonoscopy:
- Record postoperative adverse events, need for repeat endoscopy, transfusion, intervention or surgery, and final discharge diagnosis.
- Conditions
- Acute Lower Gastrointestinal Bleeding
- Being tested
- Enema Bowel preparation, PEG Bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enema Bowel preparationOther
Enema Group (Experimental Group): Enema is administered using either normal saline or 1% soapy water for cleansing until the effluent is clear of fecal debris, or until a total volume of 3000 ml of enema solution has been administered. The enema should be initiated 4-6 hours before colonoscopy, with the dosage and frequency of incremental enemas determined based on the patient's tolerance. The final enema administration should be completed no later than 10 minutes before the scheduled colonoscopy.
PEG Bowel preparationOther
Oral PEG Group (Control Group): Following the administration protocol recommended by the Chinese expert consensus for PEG, a 3 L PEG regimen is employed. The regimen involves segmented intake, with 1 L taken 10-12 hours before the intestinal examination and an additional 2 L taken 4-6 hours before the examination on the day of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Oral PEG group | Other | Following the administration protocol recommended by the Chinese expert consensus for PEG, a 3 L PEG regimen is employed. The regimen involves segmented intake, with 1 L taken 10-12 hours before the intestinal examination and an additional 2 L taken 4-6 hours before the examination on the day of the procedure. Receives: Other: PEG Bowel preparation |
| Enema group | Other | Enema is administered using either normal saline or 1% soapy water for cleansing until the effluent is clear of fecal debris, or until a total volume of 3000 ml of enema solution has been administered. The enema should be initiated 4-6 hours before colonoscopy, with the dosage and frequency of incremental enemas determined based on the patient's tolerance. The final enema administration should be completed no later than 10 minutes before the scheduled colonoscopy. Receives: Other: Enema Bowel preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic diagnosis rate
Including the definite diagnosis and presumptive diagnosis
Measured: During the colonoscopy (up to 48 hours from admission)
Secondary outcomes (13)
Cecal intubation time
The duration from the insertion of the colonoscope through the anus to reaching the cecum.
Measured: During the colonoscopy (up to 48 hours from admission)
Lesion detection time
The duration from the insertion of the colonoscope through the anus to the initial identification of lesions.
Measured: During the colonoscopy (up to 48 hours from admission)
Total procedure time
The duration from the insertion of the colonoscope through the anus to the withdrawal from the anus.
Measured: During the colonoscopy (up to 48 hours from admission)
Cecal intubation rate
The proportion of patients in the study group in whom successful cecal intubation was achieved, relative to the total number of patients in the group.
Measured: During the colonoscopy (up to 48 hours from admission)
Rate of bowel preparation related adverse events
Bowel preparation related adverse events included nausea, vomiting, bloating, hypotension, heart failure, electrolyte imbalance, aspiration pneumonia, etc.
Measured: From the start of bowel preparation to the end of bowel preparation (assessed up to 44 hours from admission)
Rate of colonoscopy related adverse events
Colonoscopy related adverse events included perforation, recurrent bleeding, post-operational infection and death.
Measured: From the start of colonoscopy to the time of discharge (assessed up to 72 hours from admission)
Rate of patients who sufferred from exacerbation of ALGIB
Exacerbation of ALGIB was defined as patients' subjective bleeding symptoms were worse than before the start of bowel preparation, or patients had a decrease in hemoglobin of more than 2g/L before and after bowel preparation.
Measured: From the start of bowel preparation to the end of bowel preparation (assessed up to 44 hours from admission)
Bowel preparation satisfaction score
The satisfaction score of bowel preparation was evaluated from three dimensions: mood, discomfort symptoms, and general feeling, with each dimension ranging from 0 to 5 indicating from the worst to the best.
Measured: At the end of bowel preparation (assessed up to 48 hours from admission)
Boston bowel preparation score
A score of 0 to 9 on the Boston Bowel Preparation scale indicates worst to best.
Measured: During the colonoscopy (up to 48 hours from admission)
Endoscopic hemostasis rate
The rate of performance of endoscopic hemostasis.
Measured: During the colonoscopy (up to 48 hours from admission)
Intervention or surgery rate
The rate of patients who underwent angiographic therapy or surgery after the primary colonoscopy.
Measured: From the end of colonoscopy to the time of discharge (assessed up to 72 hours from admission)
Repeated endoscopy rate
The rate of patients who received a second-look of colonoscopy after the primary colonoscopy.
Measured: From the end of colonoscopy to the time of discharge (assessed up to 72 hours from admission)
Transfusion rate
The rate of patients who need red blood cell transfusion after the primary colonoscopy.
Measured: From the end of colonoscopy to the time of discharge (assessed up to 72 hours from admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start8 Jan 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lower Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Li, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254443
- Sponsor's protocol ID
- BFHHZML20240002
- Acronym
- CANDLE
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Polyethylene Glycol and Enema for Diagnostic Efficacy in Urgent Colonoscopy for Acute Lower Gastrointestinal Bleeding: a Multicenter, Randomized, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06254443
- Acronym / sponsor ID
- CANDLE / BFHHZML20240002
- Conditions
- Acute Lower Gastrointestinal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 Feb 2024 (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 main goal of this study is to assess whether the diagnostic efficacy of enema is non-inferior to that of oral polyethylene glycol (PEG) in acute lower gastrointestinal bleeding (ALGIB) patients requiring urgent colonoscopy. The secondary objectives include: 1) evaluating potential differences between the enema and oral PEG groups in terms of the difficulty and safety of colonoscopy, as well as exacerbation of bleeding; 2) conducting subgroup analyses to compare the effectiveness of the two bowel preparation methods in specific populations, exploring potential candidate groups for different bowel preparation strategies, and promoting individualized diagnosis and treatment for ALGIB.
Detailed description
This is a multicenter, prospective, single-blind, randomized controlled, non-inferiority study. The study includes the following steps:
Step 1: Participants will be enrolled based on predefined criteria, and demographic data, fasting water duration, accompanying symptoms, smoking history, alcohol consumption history, antithrombotic drug usage, previous history of lower gastrointestinal bleeding, Charlson comorbidity index, vital signs at admission, and laboratory results at admission will be collected.
Step 2: All participants will undergo stratified block randomization, and based on the randomization results, participants will receive bowel preparation using either PEG or enema. Subsequently, all participants will undergo urgent colonoscopy within 48 hours from admission.
Step 3: Follow-up records will be conducted at the following time points:
- Before colonoscopy:
- Record the specific method and dosage of actual bowel preparation.
- Record changes in vital signs, symptoms, and signs before and after bowel preparation, as well as occurrences of adverse events.
- Conduct a satisfaction survey of bowel preparation.
- During colonoscopy:
- Record patient pain scores, Boston bowel preparation scores, cecal intubation time, lesion detection time, total procedure time, maximum insertion depth, observation of active bleeding, endoscopic diagnosis, endoscopic hemostasis, and perforation.
- After colonoscopy:
- Record postoperative adverse events, need for repeat endoscopy, transfusion, intervention or surgery, and final discharge diagnosis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral PEG group | Other | Other: PEG Bowel preparationFollowing the administration protocol recommended by the Chinese expert consensus for PEG, a 3 L PEG regimen is employed. The regimen involves segmented intake, with 1 L taken 10-12 hours before the intestinal examination and an additional 2 L taken 4-6 hours before the examination on the day of the procedure. |
| Enema group | Other | Other: Enema Bowel preparationEnema is administered using either normal saline or 1% soapy water for cleansing until the effluent is clear of fecal debris, or until a total volume of 3000 ml of enema solution has been administered. The enema should be initiated 4-6 hours before colonoscopy, with the dosage and frequency of incremental enemas determined based on the patient's tolerance. The final enema administration should be completed no later than 10 minutes before the scheduled colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients presenting with hematochezia who were admitted to our hospitals were eligible for the study. Patients were included if they met the following criteria:
- Had the last bloody bowel movement within 24 hours of presentation;
- Aged 18 years or over
- Had indications for clinical colonoscopy
Key exclusion criteria (11 listed)
- Known or suspected upper gastrointestinal bleeding meeting any of the following criteria:
- Previous colonoscopy has been performed at an external institution with a confirmed diagnosis.
- Presence of primary or secondary coagulation disorders.
- History of bowel diversion surgery (including partial colon resection).
- Hemodynamic instability persists after fluid resuscitation (shock index greater than 1).
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 |
|---|---|---|
| Enema Bowel preparationEnema Group (Experimental Group): Enema is administered using either normal saline or 1% soapy water for cleansing until the effluent is clear of fecal debris, or until a total volume of 3000 ml of enema solution has been administered. The enema should be initiated 4-6 hours before colonoscopy, with the dosage and frequency of incremental enemas determined based on the patient's tolerance. The final enema administration should be completed no later than 10 minutes before the scheduled colonoscopy. | Other | Enema group |
| PEG Bowel preparationOral PEG Group (Control Group): Following the administration protocol recommended by the Chinese expert consensus for PEG, a 3 L PEG regimen is employed. The regimen involves segmented intake, with 1 L taken 10-12 hours before the intestinal examination and an additional 2 L taken 4-6 hours before the examination on the day of the procedure. | Other | Oral PEG group |
Primary outcome
Endoscopic diagnosis rate
Time frame: During the colonoscopy (up to 48 hours from admission)
Including the definite diagnosis and presumptive diagnosis
13 secondary outcomes
Cecal intubation time
Time frame: During the colonoscopy (up to 48 hours from admission)
Lesion detection time
Time frame: During the colonoscopy (up to 48 hours from admission)
Total procedure time
Time frame: During the colonoscopy (up to 48 hours from admission)
Cecal intubation rate
Time frame: During the colonoscopy (up to 48 hours from admission)
Rate of bowel preparation related adverse events
Time frame: From the start of bowel preparation to the end of bowel preparation (assessed up to 44 hours from admission)
Rate of colonoscopy related adverse events
Time frame: From the start of colonoscopy to the time of discharge (assessed up to 72 hours from admission)
Rate of patients who sufferred from exacerbation of ALGIB
Time frame: From the start of bowel preparation to the end of bowel preparation (assessed up to 44 hours from admission)
Bowel preparation satisfaction score
Time frame: At the end of bowel preparation (assessed up to 48 hours from admission)
Boston bowel preparation score
Time frame: During the colonoscopy (up to 48 hours from admission)
Endoscopic hemostasis rate
Time frame: During the colonoscopy (up to 48 hours from admission)
Intervention or surgery rate
Time frame: From the end of colonoscopy to the time of discharge (assessed up to 72 hours from admission)
Repeated endoscopy rate
Time frame: From the end of colonoscopy to the time of discharge (assessed up to 72 hours from admission)
Transfusion rate
Time frame: From the end of colonoscopy to the time of discharge (assessed up to 72 hours from admission)
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 22 Jan 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enema Bowel preparation and PEG Bowel preparation in people with Acute Lower Gastrointestinal Bleeding, run by Beijing Friendship Hospital at 3 sites 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 4 inclusion and 11 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 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Endoscopic diagnosis rate (time frame: During the colonoscopy (up to 48 hours from admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2025.