Anal FistulaflapNCT01042821
Treatment of Anal Fistulas Advancement Flap
A study testing partial rectal wall advancement flap and mucosal advancement flap in people with Anal Fistula, run by Mansoura University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anal Fistula
- What is being tested?
- partial rectal wall advancement flap and mucosal advancement flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- May 2005to May 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with transphincteric anal fistula
Who cannot join
- Patients with acute sepsis, specific cause of fistula, strictured anorectum, and any degree of incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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.
- 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.
- 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.
- Conditions
- Anal Fistula
- Being tested
- partial rectal wall advancement flap, mucosal advancement flap
- Keywords
- anal fistula, advancement flap, incontinence
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial rectal wall advancement flapProcedure or surgery
Also called Group 1
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.
mucosal advancement flapProcedure or surgery
Also called advancement flap
Fistulectomy, closure of internal sphincter and rectal advancement flap includes mucosa and submucosal layer sutured 1cm below the level of internal opening
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: partial rectal wall advancement flap |
| Group 2 | Active comparator | The flap comprised mucosa, submucosa only Receives: Procedure: mucosal advancement flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
RECURRENCE OF THE FISTULA
Measured: 12 months
Secondary outcomes (1)
healing, complication, patient satisfaction
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startMay 2005
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- Wael Khafagy, MD, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042821
- Sponsor's protocol ID
- anal fistula
- Acronym
- flap
- Status last verified
- May 2005
- First submitted
- 5 Jan 2010
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19402190Dixon 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.
PubMed 15529853Christoforidis 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.
PubMed 19273951Chung 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.
PubMed 19393353Dubsky 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.
PubMed 18317841
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anal Fistulas by Partial Rectal Wall Advancement Flap or Mucosal Advancement Flap: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01042821
- Acronym / sponsor ID
- flap / anal fistula
- Conditions
- Anal Fistula
- Keywords
- anal fistula, advancement flap, incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| partial rectal wall advancement flap | Active comparator | Procedure: partial rectal wall advancement flapThe 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. |
| Group 2 | Active comparator | Procedure: mucosal advancement flapThe flap comprised mucosa, submucosa only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with transphincteric anal fistula
Key exclusion criteria (1 listed)
- Patients with acute sepsis, specific cause of fistula, strictured anorectum, and any degree of incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| partial rectal wall advancement flapAlso: Group 1The 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 or surgery | partial rectal wall advancement flap |
| mucosal advancement flapAlso: advancement flapFistulectomy, closure of internal sphincter and rectal advancement flap includes mucosa and submucosal layer sutured 1cm below the level of internal opening | Procedure or surgery | Group 2 |
Primary outcome
RECURRENCE OF THE FISTULA
Time frame: 12 months
1 secondary outcome
healing, complication, patient satisfaction
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
- Results publication: PubMed 19402190Ortiz 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.
- Results publication: PubMed 15529853Dixon 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.
- Results publication: PubMed 19273951Christoforidis 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.
- Results publication: PubMed 19393353Chung 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.
- Results publication: PubMed 18317841Dubsky 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.
- Mansoura university hospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael Khafagy, MD principal investigator
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partial rectal wall advancement flap and mucosal advancement flap in people with Anal Fistula, 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 1 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 6 Jan 2010. 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?
RECURRENCE OF THE FISTULA (time frame: 12 months). 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 NCT01042821, which also lists 5 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 6 Jan 2010.