Urgent Panendoscopy in Patients Presenting With Hematochezia

NCT06985277 | Enrolling By Invitation DMC

• 1 other identifier: Si265/2024
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

Gastrointestinal bleeding is a significant emergency condition requiring prompt diagnosis. Current evidence presents a clinical paradox: urgent colonoscopy (within 24 hours) shows no clear benefit in several studies, while urgent video capsule endoscopy (VCE) demonstrates improved detection rates for small bowel bleeding. This study aims to evaluate a novel approach combining urgent colonoscopy followed by same-day VCE for patients with normal colonoscopy findings. This strategy has not been previously assessed and may improve bleeding source detection while reducing patient preparation burden compared to standard sequential testing. Results will be compared against conventional approaches to determine optimal diagnostic timing for patients presenting with hematochezia

Conditions

Lower Gastrointestinal Bleeding; Small Bowel Bleeding

Keywords

Hematochezia; colonoscopy; video capsule endoscopy; diagnostic yield

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of urgent endoscopy compared to standard endoscopy

  The bleeding source detection rate between the urgent endoscopy strategy (colonoscopy + EGD + VCE within 24 hour of presentation) to the standard endoscopy strategy (colonoscopy + EGD + VCE within 72 hour of presentation) will be compared.

  72 hour

Secondary Outcomes (1)

• Rebleeding rate

  30 days

Study Arms (2)

Urgent colonoscopy with urgent VCE group

EXPERIMENTAL

Intervention Arm : Urgent colonoscopy with urgent VCE group : Patients will undergo colonoscopy within 24 hours of diagnosed lower gastrointestinal bleeding. If no bleeding source is identified on colonoscopy or presumed diverticular bleeding cases, esophagogastroduodenoscopy (EGD) followed by same-session video capsule endoscopy (VCE) will be performed immediately

Diagnostic Test: Urgent endoscopy strategy

Standard colonoscopy with standard VCE group

EXPERIMENTAL

Control Arm : Standard colonoscopy with standard VCE group : Patients will undergo colonoscopy within 24-48 hours after diagnosed lower gastrointestinal bleeding. If no bleeding source is identified on colonoscopy or presumed diverticular bleeding cases, esophagogastroduodenoscopy (EGD) will be performed immediately. If EGD shows no bleeding source, video capsule endoscopy (VCE) will be performed within 24 hours of the preceding endoscopies

Diagnostic Test: Standard colonoscopy with standard VCE group

Interventions

Urgent endoscopy strategy DIAGNOSTIC_TEST

Patients will undergo colonoscopy within 24 hours of diagnosed lower gastrointestinal bleeding. If no bleeding source is identified on colonoscopy or presumed diverticular bleeding cases, esophagogastroduodenoscopy (EGD) followed by same-session video capsule endoscopy (VCE) will be performed immediately

Urgent colonoscopy with urgent VCE group

Standard colonoscopy with standard VCE group DIAGNOSTIC_TEST

Patients will undergo colonoscopy within 24-48 hours after diagnosed lower gastrointestinal bleeding. If no bleeding source is identified on colonoscopy or presumed diverticular bleeding cases, esophagogastroduodenoscopy (EGD) will be performed immediately. If EGD shows no bleeding source, video capsule endoscopy (VCE) will be performed within 24 hours of the preceding endoscopies

Standard colonoscopy with standard VCE group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Admission for maroon stool and/or red blood per rectum with or without hemodynamic instability
• Hemodynamic stabilization after initial fluid resuscitation
• Correction of any coagulopathy prior to endoscopy
• Provision of informed consent

You may not qualify if:

• Hematemesis or nasogastric lavage showing coffee ground material/blood
• Persistent hemodynamic instability prior to colonoscopy
• Hospitalization in the preceding 14 days
• Contraindications to endoscopy e.g. severe asthma, cardiac disease
• Uncorrected coagulopathy
• Contraindications to bowel preparation with polyethylene glycol
• Pregnancy
• Inflammatory bowel disease

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University Bangkok, , Thailand

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 22, 2025
• Study Start: April 9, 2024
• Primary Completion: April 9, 2024
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Other researchers can contact us anytime
• Access Criteria: The investigators will provide our protocol and/or data upon request.

Locations

TH (1)