Ignite Creation Date:
2024-05-06 @ 12:34 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03791775
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2018-12-29
Brief Title:
Efficacy and Safety of Polidocanol Foam 3 in the Treatment of II Degree Hemorrhoidal Disease
Sponsor:
Societa Italiana di Chirurgia ColoRettale
Organization:
Societa Italiana di Chirurgia ColoRettale
Study Overview
Official Title:
A Multicentre Open-label Single-arm Phase II Trial on the Efficacy and Safety of Sclerotherapy Using 3 Polidocanol Foam to Treat Second-degree Hemorrhoidal Disease
Status:
COMPLETED
Status Verified Date:
2021-09
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:
SCLEROFOAM
Brief Summary:
Hemorrhoidal disease HD is one of the oldest and most common proctologic diseases that has been described with an estimated prevalence between 44 and 86 Despite the proposal of three mechanisms that might underlie haemorrhoidal development - the varicose vein theory the vascular hyperplasia theory and the sliding anal-lining theory the exact pathophysiology of symptomatic hemorrhoid disease is poorly understood
HD seems to be the most common cause for rectal bleeding or hematochezia and the second most frequent cause for severe rectorrhagia after diverticulitis The blood is bright red and coats the stool at the end of defection Other symptoms include pain mucous discharge itching or the sensation of tissue prolapse
The most widely accepted classification is the Goligher classification
Grade I hemorrhoids bleed but do not prolapse out of the anal canal
Grade II hemorrhoidal cushions prolapse outside of the anal canal on straining or during bowel movements but reduce spontaneously
Grade III hemorrhoidal cushions prolapse outside the anal canal on straining and require manual reduction
Grade IV hemorrhoidal prolapse is irreducible even with manipulation
HD seems to be the most common cause for rectal bleeding or hematochezia and the second most frequent cause for severe rectorrhagia after diverticulitis The blood is bright red and coats the stool at the end of defection Other symptoms include pain mucous discharge itching or the sensation of tissue prolapse
The most widely accepted classification is the Goligher classification
Grade I hemorrhoids bleed but do not prolapse out of the anal canal
Grade II hemorrhoidal cushions prolapse outside of the anal canal on straining or during bowel movements but reduce spontaneously
Grade III hemorrhoidal cushions prolapse outside the anal canal on straining and require manual reduction
Grade IV hemorrhoidal prolapse is irreducible even with manipulation
Detailed Description:
As reported by the guidelines of the Italian Society of Colorectal Surgery in case of failure of conservative therapies the most common outpatient treatments for first- and second-degree Hemorrhoidal Disease HD are rubber band ligation and sclerotherapy
Sclerotherapy causes an inflammatory reaction with local sclerosis of the submucosal tissue and a consequent fixation of the haemorrhoidal tissue to the underlying tissue Moreover the effect of sclerosing solutions is that of making vascular damage via producing endothelial injury
A 100 improvement in bleeding was reported in patients with II and grade III hemorrhoids and a complete resolution of the condition was described in 69 of non-selected patients 52 in grade III and 88 in grade I Resolution of prolapse was reported in 90-100 of patients affected by grade II hemorrhoids Complications are rare but serious and include impotence irreversible necrotizing fasciitis and abdominal compartment syndrome 31-33 In Germany sclerotherapy with liquid agents is considered the first choice in treating grade I hemorrhoids The only approved medical product by German authorities is polidocanol Lauromacrogol 400 INN H3C-CH211-O-CH2-CH2n9-OH produced by Chemische Fabrik Kreussler Co GmbH
In Italy this drug is known as Atossisclerol 3 The polidocanol is a non-ionic detergent made up of a chain of hydrophilic polyethylene oxide mixed with aliphatic hydrophobic dodecyl alcohol and it is recommended for first- and second-degree HD The effects of polidocanol are similar to those of phenol oil but less number of side effects
Based on these experiences Karl-Heinz Moser introduced the use of polidocanol foam in the treatment of grade I hemorrhoids In 2013 the same author published the results of a randomized controlled single blind multicentre trial on the efficacy and safety of sclerotherapy with polidocanol foam in comparison with liquid sclerosant agents in treating grade I hemorrhoids 28 In the foam group success rate after one sclerotherapy session was 88 while success rate among patients treated with liquid polidocanol was 69 Furthermore patients treated with foam were more satisfied than those treated with liquid polidocanol 99 vs 84 p0009 Finally the quantity of polidocanol injected in the foam group was significantly lower p0001 as well as the number of sessions requested p0001
In summary according to the authors these results suggest that polidocanol foam can be used as the treatment of choice in grade I HD
The aim of this study is to evaluate the efficacy and safety of sclerotherapy with 3 polidocanol foam PF on patients affected by second-degree HD
Sclerotherapy causes an inflammatory reaction with local sclerosis of the submucosal tissue and a consequent fixation of the haemorrhoidal tissue to the underlying tissue Moreover the effect of sclerosing solutions is that of making vascular damage via producing endothelial injury
A 100 improvement in bleeding was reported in patients with II and grade III hemorrhoids and a complete resolution of the condition was described in 69 of non-selected patients 52 in grade III and 88 in grade I Resolution of prolapse was reported in 90-100 of patients affected by grade II hemorrhoids Complications are rare but serious and include impotence irreversible necrotizing fasciitis and abdominal compartment syndrome 31-33 In Germany sclerotherapy with liquid agents is considered the first choice in treating grade I hemorrhoids The only approved medical product by German authorities is polidocanol Lauromacrogol 400 INN H3C-CH211-O-CH2-CH2n9-OH produced by Chemische Fabrik Kreussler Co GmbH
In Italy this drug is known as Atossisclerol 3 The polidocanol is a non-ionic detergent made up of a chain of hydrophilic polyethylene oxide mixed with aliphatic hydrophobic dodecyl alcohol and it is recommended for first- and second-degree HD The effects of polidocanol are similar to those of phenol oil but less number of side effects
Based on these experiences Karl-Heinz Moser introduced the use of polidocanol foam in the treatment of grade I hemorrhoids In 2013 the same author published the results of a randomized controlled single blind multicentre trial on the efficacy and safety of sclerotherapy with polidocanol foam in comparison with liquid sclerosant agents in treating grade I hemorrhoids 28 In the foam group success rate after one sclerotherapy session was 88 while success rate among patients treated with liquid polidocanol was 69 Furthermore patients treated with foam were more satisfied than those treated with liquid polidocanol 99 vs 84 p0009 Finally the quantity of polidocanol injected in the foam group was significantly lower p0001 as well as the number of sessions requested p0001
In summary according to the authors these results suggest that polidocanol foam can be used as the treatment of choice in grade I HD
The aim of this study is to evaluate the efficacy and safety of sclerotherapy with 3 polidocanol foam PF on patients affected by second-degree HD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None