NCT01042821

Brief Summary

This study comprises a prospective study of 40 patients with transphincteric anal fistula. The patients were classified into two groups: Group I: Fistulectomy, closure of internal sphincter and rectal advancement flap includes mucosa, submucosa, and circular muscle layer sutured 1cm below the level of internal opening. Group II: The same as group one but the flap includes only mucosa and submucosa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2005

Typical duration 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

May 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
Last Updated

January 6, 2010

Status Verified

May 1, 2005

Enrollment Period

3 years

First QC Date

January 5, 2010

Last Update Submit

January 5, 2010

Conditions

Anal Fistula

Keywords

anal fistulaadvancement flapincontinence

Outcome Measures

Primary Outcomes (1)

  • RECURRENCE OF THE FISTULA

    12 months

Secondary Outcomes (1)

  • healing, complication, patient satisfaction

    12 month

Study Arms (2)

partial rectal wall advancement flap

ACTIVE COMPARATOR

The flap comprised mucosa, submucosa and circular muscle fibers. It is raised from the dentate line and mobilized 4-6 cm cephaled and advanced to the new dendentate line (1 cm below the dentate line) and sutured with absorbable sutures (vicryl; ethicone 3/0). Also the defect is closed with absorbable sutures.

Procedure: partial rectal wall advancement flap

Group 2

ACTIVE COMPARATOR

The flap comprised mucosa, submucosa only

Procedure: mucosal advancement flap

Interventions

partial rectal wall advancement flapPROCEDURE

The flap comprised mucosa, submucosa and circular muscle fibers. It is raised from the dentate line and mobilized 4-6 cm cephaled and advanced to the new dendentate line (1 cm below the dentate line) and sutured with absorbable sutures (vicryl; ethicone 3/0). Also the defect is closed with absorbable sutures.

Also known as: Group 1
partial rectal wall advancement flap
mucosal advancement flapPROCEDURE

Fistulectomy, closure of internal sphincter and rectal advancement flap includes mucosa and submucosal layer sutured 1cm below the level of internal opening

Also known as: advancement flap
Group 2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with transphincteric anal fistula

You may not qualify if:

  • Patients with acute sepsis, specific cause of fistula, strictured anorectum, and any degree of incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, 35111, Egypt

Location

Related Publications (5)

  • Ortiz H, Marzo J, Ciga MA, Oteiza F, Armendariz P, de Miguel M. Randomized clinical trial of anal fistula plug versus endorectal advancement flap for the treatment of high cryptoglandular fistula in ano. Br J Surg. 2009 Jun;96(6):608-12. doi: 10.1002/bjs.6613.

    PMID: 19402190RESULT

  • Dixon M, Root J, Grant S, Stamos MJ. Endorectal flap advancement repair is an effective treatment for selected patients with anorectal fistulas. Am Surg. 2004 Oct;70(10):925-7.

    PMID: 15529853RESULT

  • Christoforidis D, Pieh MC, Madoff RD, Mellgren AF. Treatment of transsphincteric anal fistulas by endorectal advancement flap or collagen fistula plug: a comparative study. Dis Colon Rectum. 2009 Jan;52(1):18-22. doi: 10.1007/DCR.0b013e31819756ac.

    PMID: 19273951RESULT

  • Chung W, Kazemi P, Ko D, Sun C, Brown CJ, Raval M, Phang T. Anal fistula plug and fibrin glue versus conventional treatment in repair of complex anal fistulas. Am J Surg. 2009 May;197(5):604-8. doi: 10.1016/j.amjsurg.2008.12.013.

    PMID: 19393353RESULT

  • Dubsky PC, Stift A, Friedl J, Teleky B, Herbst F. Endorectal advancement flaps in the treatment of high anal fistula of cryptoglandular origin: full-thickness vs. mucosal-rectum flaps. Dis Colon Rectum. 2008 Jun;51(6):852-7. doi: 10.1007/s10350-008-9242-3. Epub 2008 Mar 4.

    PMID: 18317841RESULT

Related Links

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Wael Khafagy, MD

    Mansoura University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

May 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 6, 2010

Record last verified: 2005-05

Locations

EG(1)