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Trial of Endoscopy Bipolar and Argon of Chronic Rectal Bleeding From Radiation Telangiectasias
This study has been completed.
Study NCT00725244   Information provided by Federal University of São Paulo
First Received: July 28, 2008   Last Updated: October 16, 2008   History of Changes

July 28, 2008
October 16, 2008
May 2005
November 2007   (final data collection date for primary outcome measure)
Improve of rectal bleeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00725244 on ClinicalTrials.gov Archive Site
Complications of each group [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
 
Trial of Endoscopy Bipolar and Argon of Chronic Rectal Bleeding From Radiation Telangiectasias
A Randomized Prospective Study of Endoscopy Bipolar Eletrocoagulation and Argon Plasma Coagulation of Chronic Rectal Bleeding From Radiation Telangiectasias

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.

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).
Phase IV
Interventional
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
  • Radiation Injuries
  • Telangiectasis
  • Device: Bipolar eletrocoagulation
  • Device: Argon Plasma Coagulation
  • Active Comparator: 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.
  • Active Comparator: 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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
July 2008
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 88 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00725244
Luciano Henrique Lenz Tolentino, Federal University of São Paulo
556/05
Federal University of São Paulo
 
Study Director: Angelo Ferrari, PhD Federal University of São Paulo
Federal University of São Paulo
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP