Combined Method of Surgical Treatment of Anal Fissure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorState Scientific Centre of Coloproctology, Russian Federation

About this trial

The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Patients with chronic anal fissure with spasm of anal sphincter

Disqualifiers

• Inflammatory diseases of the colon

Pectenosis

Previous surgical interventions on the anal canal

IV grade internal and external hemorrhoids

Trial design

Design model

Parallel

Treatments tested in this trial

  • excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A

    Procedure/Surgery

    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

Treatment groups

122 Participants
are divided into 2 treatment groups
Group A: main groupExperimental treatment 1 intervention
Group B: control groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Anal sphincter insufficiency

Frequency of anal sphincter insufficiency according to the Wexner scale

Time frame
60 days

Secondary outcomes

1

2-item pain intensity (P2)

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 and 60
2

Non-Healing Wound

Frequency of post-operative wound epithelialization

Time frame
On day 15, 30, 45, 60
3

Profilometry /sphincterometry findings

Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry

Time frame
On day 30, 60 and 365
4

Temporary disability

Duration of temporary disability

Time frame
Up to 60 days

Other outcomes

Sponsors and contacts

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