Trial of Endoscopy Bipolar and Argon of Chronic Rectal Bleeding From Radiation Telangiectasias

Phase 4

Completed

• Conditions: Radiation Injuries; Telangiectasis

• Registration Number: NCT00725244
• Lead Sponsor: Federal University of São Paulo

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 Description

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).

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2007-11
• Status Verified: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2008-07-28
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-30
• Last Update Submitted: 2008-10-16
• Last Update Posted: 2008-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• active (at least one episode last week) and chronic (persist or appear 6 months after the conclusion of radiotherapy) rectal bleeding.
• previous radiotherapy at least 6 months ago
• presence of colonic or rectal telangiectasias
• patients that agreed to participate of the study and signed the Term of Free Consent and Cleared

Exclusion Criteria

• prior endoscopic treatment
• rectal or colonic surgery
• stenosis rectal
• rectal bleeding before radiotherapy
• severe cardiac disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improve of rectal bleeding	6 months

Secondary Outcome Measures

Name	Time	Method
Complications of each group	6 months

Trial Locations

Locations (1)

Federal University Of São Paulo - Gastroenterology; 🇧🇷 Sao Paulo, Brazil