Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prophylactic Elective Clipping of Colonic Diverticula

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02094456
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust

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.


Condition or disease Intervention/treatment Phase
Diverticular Disease Procedure: Endoscopic clipping of diverticula Procedure: Follow-up colonoscopy Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
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
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : May 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
Layout table for location information
United Kingdom
King's College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT02094456    
Other Study ID Numbers: 14/LO/0032
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: August 13, 2020
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:
Layout table for MeSH terms
Diverticulum
Diverticular Diseases
Diverticulum, Colon
Diverticulosis, Colonic
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Colonic Diseases
Intestinal Diseases