V-Y Flap for Anal Stenosis

August 12, 2025 updated by: Reham Zakaria Mohamed Ahmed, Zagazig University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharqia
      • Zagazig, Sharqia, Egypt, 44519
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of both sexes aged ≥ 18years old with moderate to severe post- hemorrhoidectomy anal stenosis

Exclusion Criteria:

  • pregnant females
  • patient with prior radiation
  • patient with T.B
  • Patient with Crohn's disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with anal stenosis
Procedure: V-Y advancement flap
anal stenosis treated by removal of scarring tissue and cover the defect using V-Y advancement flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: Intraoperative (operative time is measured in minutes from incision to wound dressing)
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
from one day to 6 months postoperative
bleeding amount
Time Frame: from incision to 2 weeks after surgery
intra and post operative bleeding amount is measured in cc by volumetric method
from incision to 2 weeks after surgery
hospital stay
Time Frame: for 1 to 2 days after surgery
the duration of hospital stay was measured in days
for 1 to 2 days after surgery
healing time
Time Frame: healing duration in days calculated from the first day post operative to 3 months
healing time was measured in days
healing duration in days calculated from the first day post operative to 3 months
post-operative analgesia
Time Frame: from one day to 2 weeks post operative
analgesia doses requirements of NSAIDs were measured in ml
from one day to 2 weeks post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
age
Time Frame: for 2 days before surgery
age was recorded in years
for 2 days before surgery
sex
Time Frame: 2 days pre-operative
sex (male or female) was recorded
2 days pre-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2023

Primary Completion (Actual)

December 17, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

March 1, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #11393-17-12-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

data will be available on demand by contacting the principle investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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