Treatment of Anal Fistulas Advancement Flap (flap)

January 5, 2010 updated by: Mansoura University

Treatment of Anal Fistulas by Partial Rectal Wall Advancement Flap or Mucosal Advancement Flap: a Prospective Randomized Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study comprises a prospective study of 40 patients with transphincteric anal fistula. They were referred to our colorectal surgery unit, Mansoura University Hospital during the period from May 2005 to May 2008. Patients with acute sepsis, specific cause of fistula, strictured anorectum, and any degree of incontinence were excluded from the study.

All patient were evaluated by digital examination, procto-sigmoidoscopy, fistulography and MRI fistulography without contrast media, using a 1.5 Tesla super conducting magnet (Magnetom Symphony MRease VA12 Siemens medical system), (either STIR or SPIR in addition to T1 weighted or T2 weighted sequences). Axial, coronal and sometimes sagittal planes were used. Preoperative assessment of anal sphincter dysfunction was done by conventional manometry using a standard low compliance water perfusions system and eight-channels catheters with pressure transducer connected to 5.5 mm manometric probe with spirally located ports at 0.5cm interval, which measured along the length of the anal canal, as well as inflatable rectal balloon. The protocol of performance is stationary pull through technique with recording the functional length of the anal canal (FL), mean maximum resting pressure in the anal canal (MRP), mean maximum squeeze pressure in the anal canal (MSP). Pressure was recorded using a computerized recording device (MMS ;Holland) which included menu-driven software to aid with data acquisition. Data were analyzed with the use of a complied software package that automatically produced numeric reports and graphs.

The patients were then classified into 2 groups. After carefully explaining the purpose of the study, an informed consent was taken from every patient. Group I: Fistulectomy, closure of internal sphincter with loose vicryl 3(0) suture and rectal advancement flap (the length 5cm of the flap is twice its width) includes mucosa, submucosa, 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.

Surgical technique:

Fleet enema was used for preoperative bowel preparation in all cases. Operation was done under general anesthesia in the lithotomy position. Prophylactic antibiotics were used with ciprofloxacin 500 mg and metronidazole 500 mg preoperatively and twice daily for 5 days. Examination under anaesthesia (EUA) was firstly performed and the extent of the disease was established by cannulating the fistulas with probes and by laying open all primary tracts, extensions, and abscesses. All the incisions and dissections were made by electrocautery. The standard procedure was to perform core fistulectomy and traversing the external sphincter until the internal sphincter was exposed the track was then transected. The crypt-bearing tissue around the internal opening of the fistula is excised, if there is difficulty in excising the main tract, the granulation tissue of the remaining tract is scraped with a curette. Advancement flap was constructed in both group.

  1. Group I: - 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.
  2. Group II: - The flap comprised mucosa, submucosa only.

Rectal pack was removed after 24 hours. The patients were allowed to drink freely for 5 days, then normal diet and laxatives. The external fistulectomy wound was dressed daily. Histopatho;ogical examination of all excised fistulous tract was done.

1. Follow up of our patients had been done for about 12 months with clinical assessment of the patients as regard. Incidence of any postoperative complications as bleeding, haematoma, ecchymosis, and disruption. Incidence of any degree of postoperative incontinence according to Cliveland clinic incontinence Score (Rockwood et al., 1999). Recurrence was defined as a discharge or abscess arising in the same area or by obvious evidence of fistulation.

Postoperative assessment of physioanatomical changes in the anal sphincter using anal manometry: 6 months post-operative after wound healing to measure MRP & MSP.

Study Type

Interventional

Enrollment (Actual)

40

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
      • Mansoura, Egypt, 35111
        • Mansoura University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with transphincteric anal fistula

Exclusion Criteria:

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: partial rectal wall advancement flap
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
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.
Other Names:
  • Group 1
Active Comparator: Group 2
The flap comprised mucosa, submucosa only
Procedure: mucosal advancement flap
Fistulectomy, closure of internal sphincter and rectal advancement flap includes mucosa and submucosal layer sutured 1cm below the level of internal opening
Other Names:
  • advancement flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RECURRENCE OF THE FISTULA
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
healing, complication, patient satisfaction
Time Frame: 12 month
12 month

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Wael Khafagy, MD, Mansoura University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

May 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

January 6, 2010

Last Update Submitted That Met QC Criteria

January 5, 2010

Last Verified

May 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • anal fistula

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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