Prophylactic Elective Clipping of Colonic Diverticula

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by King's College Hospital NHS Trust
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT02094456
First received: March 20, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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: May 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Not yet 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

No publications provided

Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT02094456     History of Changes
Other Study ID Numbers: 14/LO/0032
Study First Received: March 20, 2014
Last Updated: March 20, 2014
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 30, 2014