Clinical Trial: Trial of Endoscopy Bipolar and Argon of Chronic Rectal Bleeding From Radiation Telangiectasias
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Prospective Study of Endoscopy Bipolar Eletrocoagulation and Argon Plasma Coagulation of Chronic Rectal Bleeding From Radiation Telangiectasias
Brief Summary:
Aim:
To compare the efficacy, safety and number of sessions of bipolar eletrocoagulation (BEC) and argon plasma coagulation (APC) in the management of the bleeding telangiectasias from chronic radiation coloproctopathy (CRCP).
Methods:
Thirty patients with active bleeding from telangiectasias were enrolled in two groups (15 BEC and 15 APC) and classified according of Saunders score. BEC settings were 50 W and APC settings were 40 W and 1.0 l/min. Colonoscopy was the first exam to rule out synchronous lesions and follow-up was performed with sigmoidoscopies. Clinical cure was defined as cessation of bleeding and endoscopic cure was determined by absence of telangiectasias. Failure was defined whenever more than 7 sessions or other therapy was necessary.
Detailed Summary:
Thirty patients with active and chronic hematochezia from radiation telangiectasias were randomized in two groups :
- fifteen patients in group 1- bipolar eletrocoagulation (BE) and
- fifteen in group 2 - argon plasma coagulation(APC). For inclusion in the study, all patients were required to have active (at least one episode last week) and chronic (persist or appear 6 months after the conclusion of radiotherapy) rectal bleeding. Between May 2005 and April 2008, patients were treated and followed at the Endoscopy Unit in the São Paulo Hospital (UNIFESP).
Sponsor: Federal University of São Paulo
Current Primary Outcome: Improve of rectal bleeding [ Time Frame: 6 months ]
Original Primary Outcome:
Current Secondary Outcome: Complications of each group [ Time Frame: 6 months ]
Original Secondary Outcome:
Information By: Federal University of São Paulo
Dates:
Date Received: July 28, 2008
Date Started: May 2005
Date Completion:
Last Updated: October 16, 2008
Last Verified: July 2008
