Prophylactic Elective Clipping of Colonic Diverticula

NCT02094456 | Completed

• 1 other identifier: 14/LO/0032
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diverticular disease; diverticular bleeding; endoscopic clipping; endoscopy; lower gastrointestinal bleeding

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be episodes of recurrent bleeding requiring hospitalization.

  Postprocedure, patients will follow-up every 6 months either in Diverticular Disease clinic or via telephone checkup. These visits will ascertain whether patients have had recurrent bleeding episodes.

  12 months

Study Arms (1)

Endoscopic clipping of diverticula

EXPERIMENTAL

Endoscopic clipping of diverticula Follow-up colonoscopy

Procedure: Endoscopic clipping of diverticula; Procedure: Follow-up colonoscopy

Interventions

Endoscopic clipping of diverticula PROCEDURE

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

Endoscopic clipping of diverticula

Follow-up colonoscopy PROCEDURE

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

Endoscopic clipping of diverticula

Eligibility Criteria

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

You may qualify if:

• Patients will be included if they have been hospitalized at least once with diverticular bleeding.

You may not qualify if:

• Patients who had a definitive procedure to stop diverticular bleeding, including colectomy or angiography with embolization.
• Patients on anticoagulant agents that may not be stopped for colonoscopy.
• Patients without colonic diverticula

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Diverticular Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Amyn Haji, MSc MD FRCS

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

• Charlotte Kvasnovsky, MD MPH

  King's College Hospital NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 21, 2014
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 5, 2018
• Last Updated: August 13, 2020

Record last verified: 2016-04

Locations

GB (1)