Prophylactic Elective Clipping of Colonic Diverticula in Patients Who Have Had Sustained Lower Gastrointestinal Haemorrhage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- The primary outcome will be episodes of recurrent bleeding requiring hospitalization.
Study Overview
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.
Detailed Description
1.0 BACKGROUND AND HYPOTHESES
The investigators aim to prophylactically clip all colonic diverticula in patients who have experienced at least 1 episode of diverticular bleeding requiring hospitalization, but without definitive procedure (i.e., total colectomy or localization with embolization or clipping). The investigators' objective is to prevent future episodes of colonic bleeding from the diverticula, so as to avoid morbidity and possible mortality.
The investigators hypothesize that those patients undergoing secondary prophylaxis through diverticular clipping will experience no further episodes of diverticular bleeding.
2.0 OBJECTIVES AND 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported