Anal FissureNCT03426449
Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure
A study testing posterolateral sphincterotomy and lateral sphincterotomy in people with Anal Fissure, run by Mansoura University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Anal Fissure
- What is being tested?
- posterolateral sphincterotomy and lateral sphincterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2015to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients of both genders with chronic posterior anal fissure were included to the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure: A Randomized Clinical Trial
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.
- Conditions
- Anal Fissure
- Being tested
- posterolateral sphincterotomy, lateral sphincterotomy
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterolateral sphincterotomyProcedure or surgery
Fissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm
lateral sphincterotomyProcedure or surgery
Fissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm
| Study group | Role | What they receive |
|---|---|---|
| Posterolateral sphincterotomy | Active comparator | Division of internal anal sphincter at 5 o'clock position Receives: Procedure: posterolateral sphincterotomy |
| Lateral sphincterotomy | Active comparator | Division of internal anal sphincter at 3 o'clock position Receives: Procedure: lateral sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of healing
The time to complete healing of anal wound defined by complete epithelization of the wound
Measured: 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
Measured: 1-6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Jan 2015
- Primary completion30 Jul 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal FissureStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh H Emile, M.D., Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426449
- Sponsor's protocol ID
- mansourau45
- Status last verified
- Feb 2018
- First submitted
- 2 Feb 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterolateral Versus Lateral Internal Anal Sphincterotomy for Chronic Anal Fissure: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03426449
- Acronym / sponsor ID
- mansourau45
- Conditions
- Anal Fissure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterolateral sphincterotomy | Active comparator | Procedure: posterolateral sphincterotomyDivision of internal anal sphincter at 5 o'clock position |
| Lateral sphincterotomy | Active comparator | Procedure: lateral sphincterotomyDivision of internal anal sphincter at 3 o'clock position |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients of both genders with chronic posterior anal fissure were included to the study.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posterolateral sphincterotomyFissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm | Procedure or surgery | Posterolateral sphincterotomy |
| lateral sphincterotomyFissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm | Procedure or surgery | Lateral sphincterotomy |
Primary outcome
Duration of healing
Time frame: 6-8 weeks after surgery
The time to complete healing of anal wound defined by complete epithelization of the wound
1 secondary outcome
Anal pain
Time frame: 1-6 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Derived from this study: PubMed 29779044Alawady 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameh H Emile, M.D. principal investigator
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing posterolateral sphincterotomy and lateral sphincterotomy in people with Anal Fissure, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of healing (time frame: 6-8 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03426449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.