SSCCRussia
Moscow, 123423, Russia
Location status: Recruiting
Location contact
Evgeny E Zharkov
CONTACT
+79039689739 ext. +79039689739
Sergey A Frolov, phd
CONTACT
+79039689739 ext. 89039689739
NCT Number: NCT07268261
The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Moscow, 123423, Russia
Location status: Recruiting
Evgeny E Zharkov
CONTACT
+79039689739 ext. +79039689739
Sergey A Frolov, phd
CONTACT
+79039689739 ext. 89039689739
A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and ablebodied adults, so the issue of treatment is of particular relevance.
The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy. All the main treatment methods, such as medicinal relaxation of the internal sphincter with 0.4% nitroglycerin ointment, lateral subcutaneous sphincterotomy, and pneumodivulsion of the anal sphincter are aimed at its removal. However, the optimal method has not yet been developed. Non-surgical treatments are often attended by relapse of disease, while surgical treatment is often complicated by intestinal contents incontinence, usually gas and loose or hard stool in some occasions (grade 3 anal sphincter insufficiency). In particular, lateral subcutaneous sphincterotomy performed in such patients is associated with an increase in the degree of anal incontinence in the early postoperative period.
Botulinum Toxin Type A application in treatment of patients with chronic anal fissure (after fissure excision) is intended to improve the therapy results, namely to reduce the frequency and duration of anal sphincter insufficiency after sphincter spasm removal (reduction in the number of patients suffering from post-operative incontinence)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients undergo excision of the fissure in combination with drug relaxation of the internal sphincter with botulinum toxin type A at a dosage of 40 units of action; an additional injection of platelet-rich plasma is added
Time frame: 60 days
Frequency of anal sphincter insufficiency according to the Wexner scale
Time frame: On day 15, 30, 45 and 60
Self reported pain intensity after the defecation and during the day after the surgical intervention. Each item is scored 0-10 (0 = no pain; 10 = pain as bad, as can can be).
Time frame: On day 15, 30, 45, 60
Frequency of post-operative wound epithelialization
Time frame: On day 30, 60 and 365
Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry
Time frame: Up to 60 days
Duration of temporary disability
Time frame: Up to 60 days
Frequency of relapses
Contact information is provided by the study sponsor or research team.
Ekaterina Yu. Lebedeva
CONTACT
Evgeny E. Zharkov, MD
CONTACT
State Scientific Centre of Coloproctology, Russian Federation
Other Gov
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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