Trial of Endoscopy Bipolar and Argon of Chronic Rectal Bleeding From Radiation Telangiectasias
- Conditions
- Radiation InjuriesTelangiectasis
- Interventions
- Device: Bipolar eletrocoagulationDevice: Argon Plasma Coagulation
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- prior endoscopic treatment
- rectal or colonic surgery
- stenosis rectal
- rectal bleeding before radiotherapy
- severe cardiac disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Bipolar eletrocoagulation Bipolar Eletrocoagulation was performed with a high-frequency electrosurgical generator (ERBE® ICC 200 Eletromedizin, Tubingen, Germany), using Gold probe (Wilson- Cook®) with 7 Fr diameter and 300 cm length. The power setting was 50 W. Coagulation of each telangiectasia was achieved with the probes by applying light pressure directly on the telangiectasia. 2 Argon Plasma Coagulation Argon Plasma Coagulation was delivered using a "spray-painting" technique, with short applications at 40 W power with a gas flow of 1.0l per minute. APC equipment was an argon delivery unit (ERBE® ICC 300) coupled a high frequency surgery unit (ERBE® ICC 200). Only the end-firing probe with 2.3 mm and 220 cm length was used. The probe was purged with argon, tested and passed though the endoscope until it extends approximately 1 cm from the tip. The probe was hold just above the mucosal surface and the contact was avoided. During the procedure periodic suction was made to prevent over-distention with gas and consequently patient discomfort.
- 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