Prophylactic Elective Clipping of Colonic Diverticula
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|ClinicalTrials.gov Identifier: NCT02094456|
Recruitment Status : Unknown
Verified April 2016 by King's College Hospital NHS Trust.
Recruitment status was: Recruiting
First Posted : March 21, 2014
Last Update Posted : April 8, 2016
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 Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prophylactic Elective Clipping of Colonic Diverticula in Patients Who Have Had Sustained Lower Gastrointestinal Haemorrhage|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||May 2018|
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.
- 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.
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
|Contact: Charlotte Kvasnovsky, MD, MPH||+44(0)7539 078 firstname.lastname@example.org|
|Contact: Amyn Haji, MSc MD FRCS||+44(0)7970 292 email@example.com|
|King's College Hospital||Recruiting|
|London, United Kingdom, SE5 9RS|
|Principal Investigator: Amyn Haji, MSc MD FRCS|
|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|