High Dose Multiple Site Injection of Botox Versus Lateral Sphincterotomy in Chronic Analfissure

NCT04166175 | Completed

• 1 other identifier: anal sphincterotomy or botox
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

comparison between the effect of lateral sphincterotomy against high dose botox injection in chronic anal fissure the outcome was healing time, recurrence continence relapse pain pruritus

Conditions

Chronic Anal Fissure

Outcome Measures

Primary Outcomes (3)

• complete healing of fissure

  complete epithelialization of the floor of the chronic anal wound achieved through clinical examination at follow up visits

  2 months

• loss of anal continence

  inability to control stool or flatus measured by modified wexner score questionaire

  1 week

• recurrence

  the anal fissure reformed again after complete healing measured by clinical examination

  1 year

Secondary Outcomes (2)

• time taken for complete healing

  1 year

• post operative pain

  1 month

Study Arms (2)

group 1 botox group

ACTIVE COMPARATOR

48 patients subjected to 80 IU botox injection under GAin lithotomy position in the 5,7,11, and 1 O'clock positions

Procedure: botox injection in intersphincteric space

group 2 lateral sphincterotomy group

ACTIVE COMPARATOR

48 patients subjected to lateral internal sphincterotomy under GAin lithotomy position

Procedure: lateral internal sphincterotomy

Interventions

botox injection in intersphincteric space PROCEDURE

injection of 80 IU of botox in the intersphincteric space in 5,7,11 and 1 O'clock position

group 1 botox group

lateral internal sphincterotomy PROCEDURE

lateral internal sphincterotomy under GA in lithotomy position

group 2 lateral sphincterotomy group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients suffering chronic anal fissure aged above 16 years old

You may not qualify if:

• those with previous anal surgery,
• complicated anal fissure,
• unfit for surgery,
• specific disease as Crohn's disease and ulcerative colitis,
• malignancy,
• anal fistula or abscess
• those with systemic disease requiring treatment with calcium channel blockers and /or nitrates

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig Faculty of Medicine

Zagazig, Sharqya, 44519, Egypt

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Lateral Internal Sphincterotomy

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Digestive System Surgical Procedures; Surgical Procedures, Operative; Sphincterotomy; Myotomy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participant don't know the procedure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: two groups of patients randomly allocated group1 the botox group received 80 IU botox injection and group 2 under went lateral internal sphincterotomy

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: June 1, 2017
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: November 21, 2019

Record last verified: 2019-11

Locations

EG (1)