Diverticular DiseaseNCT02094456
Prophylactic Elective Clipping of Colonic Diverticula
A study testing Endoscopic clipping of diverticula and Follow-up colonoscopy in people with Diverticular Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Disease
- What is being tested?
- Endoscopic clipping of diverticula and Follow-up colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2016to 5 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be included if they have been hospitalized at least once with diverticular bleeding.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Elective Clipping of Colonic Diverticula in Patients Who Have Had Sustained Lower Gastrointestinal Haemorrhage
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).
Read more
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.
Read the 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.
- Conditions
- Diverticular Disease
- Being tested
- Endoscopic clipping of diverticula, Follow-up colonoscopy
- Keywords
- diverticular disease, diverticular bleeding, endoscopic clipping, endoscopy, lower gastrointestinal bleeding
- Medical subject headings
- Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic clipping of diverticulaProcedure or surgery
Colonoscopy with identification of each individual colonic diverticula and endoscopic clipping.
Follow-up colonoscopyProcedure or surgery
Patients will undergo a repeat colonoscopy 6 months after endoscopic clipping procedure.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic clipping of diverticula | Experimental | Endoscopic clipping of diverticula Follow-up colonoscopy Receives: Procedure: Endoscopic clipping of diverticula; Procedure: Follow-up colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be episodes of recurrent bleeding requiring hospitalization.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study start1 Apr 2016
- Primary completion1 Apr 2017
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticular DiseaseStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amyn Haji, MSc MD FRCS, Principal investigator, King's College Hospital NHS TrustCharlotte Kvasnovsky, MD MPH, Study director, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094456
- Sponsor's protocol ID
- 14/LO/0032
- Status last verified
- Apr 2016
- First submitted
- 20 Mar 2014
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Elective Clipping of Colonic Diverticula in Patients Who Have Had Sustained Lower Gastrointestinal Haemorrhage
- ClinicalTrials.gov ID
- NCT02094456
- Acronym / sponsor ID
- 14/LO/0032
- Conditions
- Diverticular Disease
- Keywords
- diverticular disease, diverticular bleeding, endoscopic clipping, endoscopy, lower gastrointestinal bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic clipping of diverticula | Experimental | Procedure: Endoscopic clipping of diverticula, Procedure: Follow-up colonoscopyEndoscopic clipping of diverticula Follow-up colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be included if they have been hospitalized at least once with diverticular bleeding.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic clipping of diverticulaColonoscopy with identification of each individual colonic diverticula and endoscopic clipping. | Procedure or surgery | Endoscopic clipping of diverticula |
| Follow-up colonoscopyPatients will undergo a repeat colonoscopy 6 months after endoscopic clipping procedure. | Procedure or surgery | Endoscopic clipping of diverticula |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amyn Haji, MSc MD FRCS principal investigator
King's College Hospital NHS Trust
Charlotte Kvasnovsky, MD MPH study director
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic clipping of diverticula and Follow-up colonoscopy in people with Diverticular Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be episodes of recurrent bleeding requiring hospitalization. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.