ClinicalTrials.gg
CompletedNCT03426449Updated Feb 9, 2018

Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure

An interventional study of posterolateral sphincterotomy and lateral sphincterotomy in Anal Fissure, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-09.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Jan 2015, registered Feb 2018).

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Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 14 studies in Fissure in Ano with a site in Egypt — 1 open to participants now, 1 under way, none of them phase 3. Fissure in Ano · Egypt.

Enrollment
8th of 12
80 · median 98
Started
2015
the only one that year
No phase
9 of 14
1 open now
Registered
2nd of 14
by date
Lead sponsor
8 of 14
Mansoura University

Among the 14 studies in Fissure in Ano with a site in Egypt, this one is the 8th largest by enrollment of the 12 interventional ones that give a count, is the only one that started in 2015, is one of 9 with no phase, and was the 2nd registered.

Fissure in Ano

84 studies on the registry are indexed under Fissure in Ano; 16 are open to participants now.

Browse Fissure in Ano studies →

Open to participants now

1 of the 14 studies in Fissure in Ano with a site in Egypt is open now. Recruiting first, the newest first:

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 12 Fissure in Ano studies recruiting now, 6 (50%) set no upper age limit and 5 (42%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.

This study: 16 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Anal Fissure

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04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Posterolateral sphincterotomy

    Division of internal anal sphincter at 5 o'clock position

    Procedure: posterolateral sphincterotomy

  • Active comparator
    Lateral sphincterotomy

    Division of internal anal sphincter at 3 o'clock position

    Procedure: lateral sphincterotomy

Interventions

  • Procedureposterolateral sphincterotomy

    Fissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm

  • Procedurelateral sphincterotomy

    Fissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm

06

What researchers measure

Primary outcomes

  1. Duration of healing

    The time to complete healing of anal wound defined by complete epithelization of the wound

    Time frame: 6-8 weeks after surgery

Secondary outcomes

  1. Anal pain

    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

    Time frame: 1-6 weeks after surgery

07

Study locations

1 site
  • Mansoura university hospital
    Mansourah, Dakahlia, Egypt
08

References and documents

Publications

  • 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. PubMed 29779044 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2015 to primary completion in Jul 2017, 30 months.

Of 25 interventional studies with no phase under Fissure in Ano, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 30 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2018
First posted
Feb 8, 2018
StartActual
Jan 1, 2015
Primary completionActual
Jul 30, 2017
CompletionActual
Jan 1, 2018
Last update
Feb 9, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03426449
Responsible party
Sameh Emile (Lecturer of general surgery, Mansoura University) — Principal investigator
First posted
Feb 8, 2018
Start date
Jan 1, 2015
Primary completion
Jul 30, 2017
Completion
Jan 1, 2018
Last update
Feb 9, 2018

Study contacts

Sameh H Emile, M.D.
principal investigator · Mansoura University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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