Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure

NCT03426449 — Not applicable, Completed, 80 participants, Mansoura University

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Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure: A Randomized Clinical Trial

RegistryNCT03426449
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment80 (Actual)
SponsorMansoura University (Other)
ConditionsAnal Fissure
Interventionsposterolateral sphincterotomy, lateral sphincterotomy (Procedure)
Datesstart 2015-01-01, primary completion 2017-07-30, completion 2018-01-01, first posted 2018-02-08, last updated 2018-02-09
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Anal Fissure All trials of posterolateral sphincterotomy All trials of lateral sphincterotomy

-Summary

The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence.

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+Detailed description

The present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence. We hypothesized that performing internal sphincterotomy in a point midway between the standard lateral position and the posterior midline position would confer better healing and relief of symptoms with less incidence of fecal incontinence while avoiding the development of keyhole deformity.

+Arms and interventions

ArmTypeInterventionsDescription
Posterolateral sphincterotomyActive comparatorProcedure: posterolateral sphincterotomyDivision of internal anal sphincter at 5 o'clock position
Lateral sphincterotomyActive comparatorProcedure: lateral sphincterotomyDivision of internal anal sphincter at 3 o'clock position
  • posterolateral sphincterotomy (Procedure): Fissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm
  • lateral sphincterotomy (Procedure): Fissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm

+Outcome measures

Primary outcomes

  • Duration of healing [6-8 weeks after surgery]: The time to complete healing of anal wound defined by complete epithelization of the wound

Secondary outcomes

  • Anal pain [1-6 weeks after surgery]: Degree of postoperative pain assessed by pain visual analogue scale ranging from 0-10 where 0 indicates no pain and 10 indicates the worst possible pain

+Eligibility

Sex: All, ages: 16 Years to 65 Years

Inclusion Criteria:

* Adult patients of both genders with chronic posterior anal fissure were included to the study.

Exclusion Criteria:

* Patients with anterior or lateral anal fissure,
* patients with previous anal surgery,
* patients with concomitant anorectal pathology,
* patients with secondary anal fissure due to Crohn's disease or other specific etiology,
* patients with any degree of fecal incontinence,
* patients with active anorectal sepsis.

+Locations (1)

FacilityCityCountryStatus
Mansoura university hospitalAl Mansurah, Dakahlia GovernorateEgypt

+Publications

  • Results publication: Alawady M, Emile SH, Abdelnaby M, Elbanna H, Farid M. Posterolateral versus lateral internal anal sphincterotomy in the treatment of chronic anal fissure: a randomized controlled trial. Int J Colorectal Dis. 2018 Oct;33(10):1461-1467. doi: 10.1007/s00384-018-3087-6. Epub 2018 May 19. PMID 29779044

+Investigators