Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorWestern Sydney Local Health District

About this trial

The purpose of this study is to collect prospective observational data regarding patients with diagnosed Familial Adenomatous Polyposis (FAP) undergoing cold snare polypectomy for duodenal adenomas

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient's diagnosed with a confirmed diagnosis of FAP (genetic testing) and able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent

Patients already commenced on endoscopic surveillance for FAP.

Disqualifiers

Patient's with known strictures/stenosis

Pregnancy

Patients who did not consent to study

Bleeding diathesis

Trial population

Patients with diagnosed Familial Adenomatous Polyposis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: FAP

Trial outcomes

Primary outcomes

1

Number of serious and non-serious adverse events

* bleeding risk * adenoma recurrence

Time frame
Three years

Secondary outcomes

1

Duration of endoscopic procedure

Time frame
Three years
2

Perforation (peri-procedure and delayed)

Time frame
Three years
3

Pain post procedure

Measured with 0 - 10 scale

Time frame
Three years
4

Hospital readmission

Time frame
Three years

Other outcomes

Sponsors and contacts

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