Anal StenosisNCT06860906
V-Y Flap for Anal Stenosis
A study testing V-Y advancement flap in people with Anal Stenosis, run by Zagazig University at 1 site in Egypt.
Trial summary
anal stenosis is a common complication after massive open hemorrhoidectomy. it interferes with the patient daily activities. Many interventions were described, but there is no standard treatment. Data were always lost about the best intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Stenosis
- What is being tested?
- V-Y advancement flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Dec 2023to 30 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes aged ≥ 18years old with moderate to severe post- hemorrhoidectomy anal stenosis
Who cannot join
- pregnant females
- patient with prior radiation
- patient with T.B
- Patient with Crohn's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of V-Y Anoplasty Techniques in Management of Anal Stenosis
anal stenosis is a common complication after massive open hemorrhoidectomy. it interferes with the patient daily activities. Many interventions were described, but there is no standard treatment. Data were always lost about the best intervention. In this study we try to discover if V-Y advancement flap can effectively treat anal stenosis or not.
- Conditions
- Anal Stenosis
- Being tested
- V-Y advancement flap
- Keywords
- anal stenosis, anoplasty, V-Y advancement flap
- Medical subject headings
- Anus, Imperforate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-Y advancement flapProcedure or surgery
anal stenosis treated by removal of scarring tissue and cover the defect using V-Y advancement flap
| Study group | Role | What they receive |
|---|---|---|
| patients with anal stenosis | Experimental | Not described Receives: Procedure: V-Y advancement flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
Measured: Intraoperative (operative time is measured in minutes from incision to wound dressing)
pain score
pain score was measured by visual analogue scale. maximum value 10 indicated very painful while minimum value 0 meant painless
Measured: from one day to 6 months postoperative
bleeding amount
intra and post operative bleeding amount is measured in cc by volumetric method
Measured: from incision to 2 weeks after surgery
post-operative analgesia
analgesia doses requirements of NSAIDs were measured in ml
Measured: from one day to 2 weeks post operative
hospital stay
the duration of hospital stay was measured in days
Measured: for 1 to 2 days after surgery
healing time
healing time was measured in days
Measured: healing duration in days calculated from the first day post operative to 3 months
Secondary outcomes (2)
age
age was recorded in years
Measured: for 2 days before surgery
sex
sex (male or female) was recorded
Measured: 2 days pre-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start17 Dec 2023
- Primary completion17 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal StenosisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Zakaria Mohamed Ahmed, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860906
- Sponsor's protocol ID
- #11393-17-12-2023
- Status last verified
- Dec 2023
- First submitted
- 1 Mar 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be available on demand by contacting the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of V-Y Anoplasty Techniques in Management of Anal Stenosis
- ClinicalTrials.gov ID
- NCT06860906
- Acronym / sponsor ID
- #11393-17-12-2023
- Conditions
- Anal Stenosis
- Keywords
- anal stenosis, anoplasty, V-Y advancement flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 17 Dec 2023 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 6 Mar 2025 (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.
anal stenosis is a common complication after massive open hemorrhoidectomy. it interferes with the patient daily activities. Many interventions were described, but there is no standard treatment. Data were always lost about the best intervention. In this study we try to discover if V-Y advancement flap can effectively treat anal stenosis or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with anal stenosis | Experimental | Procedure: V-Y advancement flap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both sexes aged ≥ 18years old with moderate to severe post- hemorrhoidectomy anal stenosis
Key exclusion criteria (4 listed)
- pregnant females
- patient with prior radiation
- patient with T.B
- Patient with Crohn's disease
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 |
|---|---|---|
| V-Y advancement flapanal stenosis treated by removal of scarring tissue and cover the defect using V-Y advancement flap | Procedure or surgery | patients with anal stenosis |
Primary outcome
operative time
Time frame: Intraoperative (operative time is measured in minutes from incision to wound dressing)
pain score
Time frame: from one day to 6 months postoperative
pain score was measured by visual analogue scale. maximum value 10 indicated very painful while minimum value 0 meant painless
bleeding amount
Time frame: from incision to 2 weeks after surgery
intra and post operative bleeding amount is measured in cc by volumetric method
post-operative analgesia
Time frame: from one day to 2 weeks post operative
analgesia doses requirements of NSAIDs were measured in ml
hospital stay
Time frame: for 1 to 2 days after surgery
the duration of hospital stay was measured in days
healing time
Time frame: healing duration in days calculated from the first day post operative to 3 months
healing time was measured in days
2 secondary outcomes
age
Time frame: for 2 days before surgery
sex
Time frame: 2 days pre-operative
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 14 Aug 2025.
- Individual participant dataSharing planned: Undecided. data will be available on demand by contacting the principle investigator
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V-Y advancement flap in people with Anal Stenosis, run by Zagazig 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 4 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 14 Aug 2025. 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?
operative time (time frame: Intraoperative (operative time is measured in minutes from incision to wound dressing)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.