Oral PEG vs. Enema in Urgent Colonoscopy for ALGIB

NCT06254443 | Completed

• 1 other identifier: BFHHZML20240002
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Acute Lower Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• Endoscopic diagnosis rate

  Including the definite diagnosis and presumptive diagnosis

  During the colonoscopy (up to 48 hours from admission)

Secondary Outcomes (13)

• Cecal intubation time

  During the colonoscopy (up to 48 hours from admission)

• Lesion detection time

  During the colonoscopy (up to 48 hours from admission)

• Total procedure time

  During the colonoscopy (up to 48 hours from admission)

• Cecal intubation rate

  During the colonoscopy (up to 48 hours from admission)

• Rate of bowel preparation related adverse events

  From the start of bowel preparation to the end of bowel preparation (assessed up to 44 hours from admission)

Study Arms (2)

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.

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.

Other: Enema Bowel preparation

Interventions

Enema Bowel preparation OTHER

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.

Enema group

PEG Bowel preparation OTHER

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.

Oral PEG group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known or suspected upper gastrointestinal bleeding meeting any of the following criteria:
• A. 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).
• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (3)

Tongliao City Hospital

Tongliao, Neimenggu, China

Location

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Science and Technology Department

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: February 12, 2024
• Study Start: January 8, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)