Ignite Creation Date:
2024-05-06 @ 2:41 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02104271
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2014-03-13
Brief Title:
Comparison Between Two Different Parameters of Argon Plasma Coagulation in the Treatment of Chronic Radiation Proctitis Historical Control Trial
Sponsor:
Barretos Cancer Hospital
Organization:
Barretos Cancer Hospital
Study Overview
Official Title:
Comparison Between Two Different Parameters of Argon Plasma Coagulation in the Treatment of Chronic Radiation Proctitis Historical Control Trial
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is a wide variability of options for treatment of chronic radiation proctitis However studies are still limited usually case reports from a single center and few are comparative studies between methods Therefore the choice of treatment is determined by availability and local expertise for each method The variability of treatment options range from anti-inflammatory medical treatment sucralfate short chain fatty acids antioxidants and hyperbaric oxygen to such endoscopic and surgical treatments Surgery is usually the last therapeutic option due to the high morbidity and mortalityassociated Various endoscopic treatment modalities have been reported Formalin topic is effective in up to 48 of patients with chronic radiation proctitis
The endoscopic treatment with argon plasma APC is low cost easy to apply and transportation safe and effective in the treatment of rectal bleeding in patients with chronic radiation proctitis Currently the APC is the preferred endoscopic modality
Most studies on the use of APC in radiation proctitis showed benefit The APC controls the mild to moderate rectal bleeding in 80 to 90 of cases and improves symptoms of urgency diarrhea and tenesmus in 60 to 75 of cases
The endoscopic treatment with argon plasma APC is low cost easy to apply and transportation safe and effective in the treatment of rectal bleeding in patients with chronic radiation proctitis Currently the APC is the preferred endoscopic modality
Most studies on the use of APC in radiation proctitis showed benefit The APC controls the mild to moderate rectal bleeding in 80 to 90 of cases and improves symptoms of urgency diarrhea and tenesmus in 60 to 75 of cases
Detailed Description:
APC is usually applied with a power of 40-60W and 12-25 Lmin of gas flow by using a electrosugical generator coupled with an argon delivery unit However high gas flow have been associated to high rates of complication such as rectal stenosis and deep rectal ulcer
In this context the present study aims to compare the effectiveness and safety between two different paramenters of argon plasma coagulation 40-50W and 20 Lmin of gas flow vs 40W and 12 Lmin of gas flow in the treatment of patients with symptomatic chronic radiation proctitis
In this context the present study aims to compare the effectiveness and safety between two different paramenters of argon plasma coagulation 40-50W and 20 Lmin of gas flow vs 40W and 12 Lmin of gas flow in the treatment of patients with symptomatic chronic radiation proctitis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None