Comparison of Botulinum Toxin Injection and Lateral Internal Sphincterotomy in Chronic Anal Fissure Management (BOT-LIS-CAF)
A Prospective Comparative Study of Clinical Outcomes Between Botulinum Toxin Injection and Lateral Internal Sphincterotomy in the Management of Chronic Anal Fissure
This study aims to compare two commonly used treatments for chronic anal fissure: botulinum toxin injection and lateral internal sphincterotomy. Chronic anal fissure is a painful condition that causes severe discomfort during bowel movements and can significantly affect a patient's quality of life.
Botulinum toxin injection is a minimally invasive procedure that temporarily relaxes the anal sphincter muscle to promote healing. In contrast, lateral internal sphincterotomy is a minor surgical procedure that permanently reduces sphincter pressure and is considered the standard treatment with high healing rates.
A total of 90 adult patients with chronic anal fissure will be enrolled and divided into two groups. One group will receive botulinum toxin injection, while the other group will undergo lateral internal sphincterotomy. Patients will be followed up regularly to assess healing, pain relief, recurrence of the fissure, and any complications such as incontinence.
The purpose of this study is to determine which treatment provides better outcomes in terms of effectiveness and safety, helping doctors choose the most appropriate treatment for patients.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Federal
-
Islamabad, Federal, Pakistan, 44000
- Islamabad Medical and Dental College
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Age 18-65 years
- Diagnosed chronic anal fissure (>6 weeks duration)
- Failure of conservative management
- Both male and female patients
- Willingness to provide informed consent
Exclusion Criteria:
- Acute anal fissure
- Previous anal surgery
- Inflammatory bowel disease
- Pregnancy
- Neurological disorders affecting continence
- Known hypersensitivity to botulinum toxin
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Botulinum Toxin Injection
Participants in this arm will receive an intrasphincteric injection of 20 units of botulinum toxin type A. The toxin will be diluted in 1 ml of normal saline and administered as two injections of 10 units each at the 3 o'clock and 9 o'clock positions in the intersphincteric plane under aseptic conditions using a 26-30 gauge needle.
|
A total dose of 20 units of botulinum toxin type A will be administered via intrasphincteric injection.
The toxin will be diluted in 1 ml of normal saline and injected into the internal anal sphincter in two equal doses of 10 units each at the 3 o'clock and 9 o'clock positions in the intersphincteric plane using a 26-30 gauge needle under aseptic conditions.
|
|
Aktiv komparator: Lateral Internal Sphincterotomy
Participants in this arm will undergo open lateral internal sphincterotomy under spinal anesthesia.
A small incision will be made at the lateral position (3 o'clock), and the lower one-third of the internal anal sphincter will be divided under direct vision.
Hemostasis will be secured, and the wound will be left open for secondary healing
|
An open lateral internal sphincterotomy will be performed under spinal anesthesia.
A small lateral incision will be made at the 3 o'clock position, and the lower one-third of the internal anal sphincter will be divided under direct vision.
Hemostasis will be achieved, and the wound will be left open to heal by secondary intention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of patients with complete fissure healing at 3 months after treatment (Botulinum toxin vs. Lateral Internal Sphincterotomy). This is the main endpoint on which your sample size calculation and comparative effectiveness analysis are based.
Tidsramme: 3 months for healing after intervention
|
3 months for healing after intervention
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Aminosyrer, peptider og proteiner
- Proteiner
- Kirurgiske prosedyrer, operativ
- Biologiske faktorer
- Hydrolaser
- Enzymer
- Enzymer og koenzymer
- Fordøyelsessystem kirurgiske inngrep
- Botulinumtoksiner
- Metalloendopeptidaser
- Endopeptidaser
- Peptidhydrolaser
- Metalloproteaser
- Bakterielle proteiner
- Bakterielle giftstoffer
- Giftstoffer, biologisk
- Myotomi
- Sfinkterotomi
- Botulinumtoksiner, type A
- Lateralt intern sfinkterotomi
Andre studie-ID-numre
- ANTH-GS-CAF-2026
Legemiddel- og utstyrsinformasjon, studiedokumenter
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