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Anal StenosisNCT00883571

Comparative Study of the House Advancement Flap, Rhomboid Flap, and Y-V Anoplasty

A study testing house advancement flap group, Rhomboid flap GROUP and Y-V anoplasty GROUP in people with Anal Stenosis, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 66 years
Conditions the study is for
Anal Stenosis
What is being tested?
house advancement flap group, Rhomboid flap GROUP and Y-V anoplasty GROUP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
Apr 2002to Dec 2008
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 to 66 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ALL PATIENTS with anal stenosis

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mansoura University

    Al Mansurah, 35111

Other trials in Egypt

About this study

Official title: Comparative Study of the House Advancement Flap, Rhomboid Flap, and Y-V Anoplasty in Treatment of Anal Stenosis: A Prospective Randomized Study

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.

Read the detailed description

Informed consent was obtained from all patients to be included in the study, after explanations the nature of the disease and possible treatment. This study was approved by local ethical committee.

The patients were then randomized into three groups. The randomization was achieved through computer-generated schedule and its results were sealed into 60 envelopes. The responsible surgeon opened randomly an envelop and, accordingly to the protocol.

Group 1: consists of 20 (14 males and 6 females) patients underwent house door flap.

Group II: consists of 20 patients (16 males and 4 females) underwent romboid flap.

Group III: consists of 20 patients underwent V-Y anoplasty (13 males and 7 females).

In group I: 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.

In group II: a rhomboid flap was incised in ischiorectal 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 strictured area using vicryl 3/0.

In group III: V-Y anoplasty is 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.

Patients were discharged 48 hours after the procedure. A high-fiber diet combined with bulk laxatives with oral antibiotic coverage was recommended after discharge. After each bowel movement, cleansing of the operative site with a sitz bath or shower was prescribed.

Patients were discharged 48 hours after the procedure. A high-fiber diet combined with bulk laxatives with oral antibiotic coverage was recommended after discharge. After each bowel movement, cleansing of the operative site with a sitz bath or shower was prescribed.

The parameters investigated were time of relief of painful defecation, the straining severity, sensation of incomplete evacuation and need for laxative or enema. postoperative anal caliber, healing rate, recurrence, quality of life (QOL) was assessed with Gastrointestinal quality of life index (GIQLI) which is a relatively new and validated tool for measuring the QOL in patients with gastrointestinal diseases. The GIQLI developed by Eypasch and coworkers (6). The questionnaire comprises 36 multidimensional items covering symptoms and physical, emotional, and social dysfunction related to gastrointestinal diseases or their treatments. Each item is scored from 0 to 4 points. The GIQLI score is calculated by simple addition of all item scores so that an overall score of 0 would constitute the worst, while a score of 144 (36 X 4) represents the best possible result. It is also possible to evaluate the disease-specific, social, psychologic, and physical items as separate subgroups. The patients were asked to complete the GIQLI questionnaire at admission to the hospital and one year after surgery under the supervision of the same independent authors.

Conditions
Anal Stenosis
Being tested
house advancement flap group, Rhomboid flap GROUP, Y-V anoplasty GROUP
Keywords
anal stenosis, flaps, anoplasty
Medical subject headings
Anus, Imperforate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • house advancement flap groupProcedure or surgery

    Also called group 1

    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.

  • Rhomboid flap GROUPProcedure or surgery

    Also called Group 11

    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.

  • Y-V anoplasty GROUPProcedure or surgery

    Also called group 111

    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.

Study groups in NCT00883571
Study groupRoleWhat they receive
house advancement flapActive comparatorhouse advancement flap
Receives: Procedure: house advancement flap group
Rhomboid flapActive comparatorrhomboid 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
Receives: Procedure: Rhomboid flap GROUP
Y-V anoplastyActive comparatorY-V anoplasty
Receives: Procedure: Y-V anoplasty GROUP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative anal caliber

    Measured: 1 year

Secondary outcomes (1)
  1. clinical improvement, complications, recurrence, patient satisfaction, postoperative incontinence, and quality of life

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2009 (estimated)
  2. Study startApr 2002
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

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
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00883571
Sponsor's protocol ID
anal stenosis
Status last verified
Apr 2009
First submitted
16 Apr 2009
Last updated
29 Dec 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15838576
  • 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.

    PubMed 18679744
  • 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.

    PubMed 7749697

Questions about this trial

What is this clinical trial studying?

A study testing house advancement flap group, Rhomboid flap GROUP and Y-V anoplasty GROUP in people with Anal Stenosis, 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 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 29 Dec 2009. 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?

postoperative anal caliber (time frame: 1 year). 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 NCT00883571, which also lists 3 linked publications.

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 29 Dec 2009.

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