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Prophylactic Elective Clipping of Colonic Diverticula

NCT02094456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-08-13

No results posted yet for this study

Summary

Diverticular bleeding is the most common cause of acute lower gastrointestinal bleeding (LGIB) in Western populations. Although self-limited in 85% of cases, some patients may require hospitalization with blood transfusion and emergent intervention, with significant associated morbidity and mortality. Up to 25% of patients with an initial bleeding episode will have subsequent episodes.

Diverticula form at weak points along the colon wall, where the vasa recta enter the circular muscle layer of the colon. Diverticular bleeding is attributed to thinning of the blood vessels as they cross over the dome of a diverticulum. Endoscopic clipping of actively bleeding colonic diverticula has been recognized as a safe and effective treatment for acute LGIB since the mid1990s. Patients selected would have had previous colonoscopy to exclude other causes of bleeding (e.g. angiodysplasia, colorectal cancer).

The investigators propose prophylactic elective endoscopic diverticular clipping in patients who have had at least 1 episode of acute LGIB requiring hospitalization. This would involve applying endoscopic clips to the base of every diverticula in a patient's colon, such that any bleeding source would effectively be excluded. The investigators would later reevaluate patients for colonoscopic appearance of diverticula to assess their diverticular disease.

The investigators hypothesize that patients undergoing endoscopic diverticular clipping will not have repeat episodes of bleeding.

Conditions

  • Diverticular Disease

Interventions

PROCEDURE

Endoscopic clipping of diverticula

Colonoscopy with identification of each individual colonic diverticula and endoscopic clipping.

PROCEDURE

Follow-up colonoscopy

Patients will undergo a repeat colonoscopy 6 months after endoscopic clipping procedure.

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Amyn Haji, MSc MD FRCS · King's College Hospital NHS Trust

  • Charlotte Kvasnovsky, MD MPH · King's College Hospital NHS Trust

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2017-04-01
Completion
2018-05-05

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02094456 on ClinicalTrials.gov