Clinical trial NCT02094456: Prophylactic Elective Clipping of Colonic Diverticula
Official title: Prophylactic Elective Clipping of Colonic Diverticula in Patients Who Have Had Sustained Lower Gastrointestinal Haemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diverticular Disease
Keywords: diverticular disease
diverticular bleeding
endoscopic clipping
endoscopy
lower gastrointestinal bleeding
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 mid-1990s. 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 re-evaluate patients for colonoscopic appearance of diverticula, as there is some suggestion that diverticula may resolve after such management.

3.0 STUDY DESIGN

The investigators propose a prospective feasibility study of outpatients who have previously been hospitalized with at least one episode of diverticular bleeding. Diverticular disease will have been confirmed by previous colonoscopy to assess the extent of diverticular disease. Consecutive patients at follow-up outpatient appointments will be approached with a Patient Information Sheet. On follow-up appointment they will be recruited and enrolled for endoscopic clipping of colonic diverticula.

The procedure itself will be similar to a screening colonoscopy. As outpatients, patients will take bowel preparation. Colonoscopy will occur with sedation only, including fentanyl and midazolam per protocol. Individual colonic diverticula will be clipped to exclude the bleeding source.

Twenty-four (24) patients will be enrolled for diverticular clipping. These patients will be followed prospectively for 2 years for repeat bleeding episodes. Follow-up will consist of telephone calls every 6 months by the study team. In addition, patients will be scheduled for repeat colonoscopy to assess their diverticular disease 6 months after clipping of colonic diverticula.

4.0 SELECTION AND WITHDRAWAL OF SUBJECTS Currently, patients admitted with complications of diverticular disease are seen in Diverticular Disease clinic for follow-up. Consecutive patients will be selected from this patient population.

Patients may withdrawal from the study at any time, including during the colonoscopy with clipping of diverticula.

5.0 DATA COLLECTION AND MONITORING

Data collection will take place on a specially created case report form (See case report form version 1.2). Case report forms will be stored in a locked office in the Department of Colorectal Surgery accessible only to the study team. Data will be entered into an excel spreadsheet. The spreadsheet will be kept on a password protected NHS desktop in a locked office in the Department of Colorectal Surgery.

6.0 STATISTICAL CONSIDERATIONS

As this is a feasibility study, recruited patients will be study prospectively. Any analysis will include all patients enrolled. There will be no control group or randomization at this time.

Eligibility 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

Primary outcomes:
measure: The primary outcome will be episodes of recurrent bleeding requiring hospitalization.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: King's College Hospital NHS Trust
name: Amyn Haji, MSc MD FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College Hospital NHS Trust
name: Charlotte Kvasnovsky, MD MPH
role: STUDY_DIRECTOR
References: