Blood Flow Monitoring to Prevent Post-Polypectomy Induced Ulcer Bleeding
United States180 participantsStarted 2017-02-15
Plain-language summary
The primary specific aim is to perform a randomized controlled trial (RCT) to compare rates of delayed hemorrhage after DEP detection of arterial blood flow and focal treatment in PPIU's (treatment arm) with standard treatment using medical guidelines alone (controls) for prevention of delayed bleeding in high risk patients (on anti-coagulants or anti-platelet drugs or with large ulcers) after snare resection of benign colon polyps.
Who can participate
Age range35 Years
SexALL
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Inclusion Criteria:
* Ambulatory patients, 35 years old or more and who are having:
* elective, outpatient screening
* surveillance colonoscopy for colon cancer or polyps
* or being evaluated for abdominal pain or change in bowel habits ---or have a large polyp needing removal by EMR or ESD
* Clinically the patient has to have a medical indication and recommendation by their primary care physician (PCP) or specialist to take:
* daily anti-coagulants (Warfarin, low-molecular-weight heparin \[LMWH\] or a newer agent)
* or an anti-platelet drug (aspirin as 81 mg or more, Clopidogrel, or newer agents) for PPIU's 10-14mm
* or if not on one of these drugs, they must have a PPIU 15 mm
* On colonoscopy, they are required to have:
* benign appearing polyps and for 1 or more PPIU to be 10 mm in size (for the anti-coagulant or anti-platelet groups)
* or 15 mm or larger for the PPIU group who do not have to be (but may be) on these drugs that can induce bleeding
* In the case of bleeding from the PPIU during polypectomy, hemorrhage must be completely controlled
Exclusion Criteria:
* Inability or unwillingness to give written informed consent or to return to the investigators' medical centers for follow-up (FU) in the next 30 days, in case of delayed bleeding or other complications
* Intrinsic bleeding disorder with a history of recurrent bleeding either after:
* surgeries
* angiography
* or other invasive procedures
* Significantly abnormal coagulation tests …
What they're measuring
1
The proportion of participants with delayed Post-Polypectomy Induced Ulcer (PPIU) bleeds.
Timeframe: Outcome measure will be assessed at 30 days after participants are enrolled.