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Prophylactic Elective Clipping of Colonic Diverticula

This study is currently recruiting participants.
Verified April 2016 by King's College Hospital NHS Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT02094456
First Posted: March 21, 2014
Last Update Posted: April 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
King's College Hospital NHS Trust
  Purpose

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.


Condition Intervention
Diverticular Disease Procedure: Endoscopic clipping of diverticula Procedure: Follow-up colonoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylactic Elective Clipping of Colonic Diverticula in Patients Who Have Had Sustained Lower Gastrointestinal Haemorrhage

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • The primary outcome will be episodes of recurrent bleeding requiring hospitalization. [ Time Frame: 12 months ]
    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.


Estimated Enrollment: 24
Study Start Date: March 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endoscopic clipping of diverticula
Endoscopic clipping of diverticula Follow-up colonoscopy
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who had a definitive procedure to stop diverticular bleeding, including colectomy or angiography with embolization.
  • Patients who are considered too high risk for colonoscopy or bowel preparation. There will be no exclusion criteria based on age. Rather, patients will be individually evaluated and judged for frailty.
  • Patients on anticoagulant agents that may not be stopped for colonoscopy.
  • Patients without colonic diverticula
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094456


Contacts
Contact: Charlotte Kvasnovsky, MD, MPH +44(0)7539 078 406 ckvasnovsky@nhs.net
Contact: Amyn Haji, MSc MD FRCS +44(0)7970 292 532 amynhaji@nhs.net

Locations
United Kingdom
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Principal Investigator: Amyn Haji, MSc MD FRCS         
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Principal Investigator: Amyn Haji, MSc MD FRCS King's College Hospital NHS Trust
Study Director: Charlotte Kvasnovsky, MD MPH King's College Hospital NHS Trust
  More Information

Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT02094456     History of Changes
Other Study ID Numbers: 14/LO/0032
First Submitted: March 20, 2014
First Posted: March 21, 2014
Last Update Posted: April 8, 2016
Last Verified: April 2016

Keywords provided by King's College Hospital NHS Trust:
diverticular disease
diverticular bleeding
endoscopic clipping
endoscopy
lower gastrointestinal bleeding

Additional relevant MeSH terms:
Diverticulum, Colon
Gastrointestinal Hemorrhage
Diverticulum
Diverticulosis, Colonic
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Pathologic Processes
Pathological Conditions, Anatomical
Colonic Diseases
Intestinal Diseases