V-Y Flap for Anal Stenosis

NCT06860906 | Completed DMC

• 1 other identifier: #11393-17-12-2023
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. In this study we try to discover if V-Y advancement flap can effectively treat anal stenosis or not.

Conditions

Anal Stenosis

Keywords

anal stenosis, anoplasty, V-Y advancement flap

Outcome Measures

Primary Outcomes (6)

• operative time

  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

  from one day to 6 months postoperative

• bleeding amount

  intra and post operative bleeding amount is measured in cc by volumetric method

  from incision to 2 weeks after surgery

• post-operative analgesia

  analgesia doses requirements of NSAIDs were measured in ml

  from one day to 2 weeks post operative

• hospital stay

  the duration of hospital stay was measured in days

  for 1 to 2 days after surgery

• healing time

  healing time was measured in days

  healing duration in days calculated from the first day post operative to 3 months

Secondary Outcomes (2)

• age

  for 2 days before surgery

• sex

  2 days pre-operative

Study Arms (1)

patients with anal stenosis

EXPERIMENTAL

Procedure: V-Y advancement flap

Interventions

V-Y advancement flap PROCEDURE

anal stenosis treated by removal of scarring tissue and cover the defect using V-Y advancement flap

patients with anal stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Anus, Imperforate

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of general surgery

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 6, 2025
• Study Start: December 17, 2023
• Primary Completion: December 17, 2024
• Study Completion: December 30, 2024
• Last Updated: August 14, 2025

Record last verified: 2023-12

Locations

EG (1)