NCT00883571

Brief Summary

This prospective randomized study included 60 consecutive patients suffering from anal stenosis in the period from April 2002 to December 2008. They admitted to colorectal surgery unit, Mansoura university hospital, Egypt. According to the classification proposed by Milson and Mazier(5), all patients had moderate to severe anal stenosis. There were 43 males and 17 female with a mean age 34 + 5.2 years ranging from 18 up to 63 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
Last Updated

December 29, 2009

Status Verified

April 1, 2009

Enrollment Period

6.7 years

First QC Date

April 16, 2009

Last Update Submit

December 28, 2009

Conditions

Anal Stenosis

Keywords

anal stenosisflapsanoplasty

Outcome Measures

Primary Outcomes (1)

  • postoperative anal caliber

    1 year

Secondary Outcomes (1)

  • clinical improvement, complications, recurrence, patient satisfaction, postoperative incontinence, and quality of life

    1 year

Study Arms (3)

house advancement flap

ACTIVE COMPARATOR

house advancement flap

Procedure: house advancement flap group

Rhomboid flap

ACTIVE COMPARATOR

rhomboid flapa was incised in the ischiorectal fossa. Without undermining of its fatty base, the flap was then mobilized into the anal canal so that the tip could be sutured to the top of the strictured area using Vicryl 3/0 sutures

Procedure: Rhomboid flap GROUP

Y-V anoplasty

ACTIVE COMPARATOR

Y-V anoplasty

Procedure: Y-V anoplasty GROUP

Interventions

house advancement flap groupPROCEDURE

A house flap of healthy tissue was incised to the depth of ischiorectal fat. The flap consisted of skin and subcutaneous tissue. The flap was sufficiently mobilized without undermining its fatty base containing perforating blood vessels. The flap should be loose and easily advanced into the anal canal. When the ''base'' of this house-shaped flap was advanced into the anal canal defect, it was fixed to the top of the excised area with 3/0 Vicryl sutures.

Also known as: group 1
house advancement flap
Rhomboid flap GROUPPROCEDURE

A rhomboid flap was incised in ischeorectal fossa and was mobilized without undermining of its fatty base into the anal canal so that the tip of rhomboid flap is sutured to the top of stricured area using vicryl 3/0.

Also known as: Group 11
Rhomboid flap
Y-V anoplasty GROUPPROCEDURE

Y-V anoplastyis performed by making a v shaped incision in the perianal skin posteriorly starting from the lower end of the wound resultant from excision of scared area. A V-shaped flap is then dissected with preservation fatty base .The V flap is then advanced into the anal canal so that its tip is sutured to the top of structured area using vicryel 3/0.

Also known as: group 111
Y-V anoplasty

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ALL PATIENTS with anal stenosis

You may not qualify if:

  • Pregnant female
  • Malignant stenosis
  • Associated anal pathology
  • Anal stenosis with a anal diameter more than 20 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 35111, Egypt

Location

Related Publications (3)

  • Habr-Gama A, Sobrado CW, de Araujo SE, Nahas SC, Birbojm I, Nahas CS, Kiss DR. Surgical treatment of anal stenosis: assessment of 77 anoplasties. Clinics (Sao Paulo). 2005 Feb;60(1):17-20. doi: 10.1590/s1807-59322005000100005. Epub 2005 Mar 1.

    PMID: 15838576RESULT

  • Alver O, Ersoy YE, Aydemir I, Erguney S, Teksoz S, Apaydin B, Ertem M. Use of "house" advancement flap in anorectal diseases. World J Surg. 2008 Oct;32(10):2281-6. doi: 10.1007/s00268-008-9699-1.

    PMID: 18679744RESULT

  • Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.

    PMID: 7749697RESULT

Related Links

MeSH Terms

Conditions

Anus, Imperforate

Interventions

gene 11 protein, Rotavirus B

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • mohamed yousef

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 17, 2009

Study Start

April 1, 2002

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 29, 2009

Record last verified: 2009-04

Locations

EG(1)