Anorectal FistulaNCT04357210
Anal Sphincter Reconstruction After High Recurrent Anorectal Fistula Excision
An observational study of Anorectal Fistula, run by Russian Society of Colorectal Surgeons.
Trial summary
A retrospective analysis of patients treated for recurrent posterior anorectal fistula, who previously had undergone radical excision of fistula-in-ano, was performed. Three types of surgical reconstruction were compared: fistulectomy with primary sphincteroplasty, muco-muscular advancement flap and full-thickness low… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anorectal Fistula
- What is being tested?
- fistula tract excision and anal sphincter reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 May 2018
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women with high recurrent posteriorly located anorectal fistulas
Who may be able to join
- recurrent posterior anorectal fistula
- previously had undergone radical excision
- contrast-enhanced MRI performed preoperatively
- colonoscopy preoperatively
Who cannot join
- Crohn's disease
- superficial fistulas
- low intersphincteric fistulas
- infections (anorectal sepsis, tuberculosis, HIV)
About this study
Official title: Uni-center, Retrospective Observational Study to Compare Outcomes of Fistulectomy With Primary Sphincteroplasty, Advancement Flap and Full-thickness Low Rectum Posterior Mobilization After Excision of a High Recurrent Anorectal Fistula
A retrospective analysis of patients treated for recurrent posterior anorectal fistula, who previously had undergone radical excision of fistula-in-ano, was performed. Three types of surgical reconstruction were compared: fistulectomy with primary sphincteroplasty, muco-muscular advancement flap and full-thickness low rectum posterior semicircular mobilization.
Read the detailed description
Radical surgical treatment of anorectal fistulas implies removal of the tract, which ideally should be followed by complete wound healing and good anal sphincter function. A big variety of techniques to restore the anal canal after fistula excision have been developed, however, none of them demonstrates excellent results in difficult clinical situations. Treatment of high anorectal fistulas, as well as recurrent fistulas, has always been the most challenging task even for expert colorectal surgeons, considering the need to safely restore the anal sphincters after surgical trauma in the presence of severe postoperative fibrosis and inflammatory changes.
In high recurrent anorectal fistulas, fistulotomy isn't a method of choice as division of a big portion of anal sphincter muscles leads to postoperative incontinence. Muco-muscular advancement flap is an accepted technique for the treatment of high transsphincteric fistulas, showing the best efficacy in unchanged anal canal. Whereas in recurrent disease, due to severe fibrotic deformation of the anal canal, creating an advancement flap can be technically difficult and lead to a complication high rate and postoperative incontinence.
Creation and safe fixation of an endorectal advancement flap (ERAF) in the setting of postoperative fibrosis and perifistular inflammation can be technically difficult. Thus, mobilizing a full-thickness flap is preferred.
After coring out a high transsphincteric or suprasphincteric fistula, the wound from the inside of the anal canal is located close to the anorectal junction, where internal and external anal sphincter fuse with the levator ani muscles. When a full-thickness ERAF is created in this situation, first the surgeon enters the intersphincteric plane, and upward dissection brings him straight to the supralevator space.
This maneuver has much in common with mobilising the distal part of rectum as a part of intersphincteric resections or transanal mesorectal excision for rectal cancer [35] , [36] . After the upper part of the rectum has been mobilized, a surgeon from the perineal team makes a circular incision of the anal canal above the dentate line, enters the intersphincteric space and continues dissection in cranial direction following the surface of the mesorectal fascia, thus separating the lower part of mesorectum from the levator ani muscles.
Being an expert in intersphincteric resections, the leading surgeon utilized this approach in three patients after excision of a high recurrent anal fistula. Sphincteroplasty and standard ERAF creation were not possible due to severe fibrosis, so mobilizing the posterior semicircle of the rectum the same way as in intersphincteric rectal resection was deemed to be the last resort in order to close the wound. In fact, a wide well-vascularized posterior ERAF was created. The upward dissection was continued until the Waldeyer's septum was reached and divided to ensure tension-free fixation of the flap in the anal canal.
- Conditions
- Anorectal Fistula
- Being tested
- fistula tract excision and anal sphincter reconstruction
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fistula tract excision and anal sphincter reconstructionProcedure or surgery
The primary fistulous tract was excised together with any secondary tracts or residual cavities. Then on of the reconstructive steps was performed
| Study group | Role | What they receive |
|---|---|---|
| primary sphincteroplasty | end-to-end primary sphincteroplasty with interrupted sutures Receives: Procedure: fistula tract excision and anal sphincter reconstruction | |
| muco-muscular advancement flap | A U-shaped muco-muscular flap was mobilized and fixed to the anoderm with one-row interrupted absorbable sutures Receives: Procedure: fistula tract excision and anal sphincter reconstruction | |
| full-thickness low rectum posterior semicircular mobilization | Proximal parts of the internal sphincter and the longitudinal muscle were carefully separated from the underlying external sphincter and puborectalis muscle, moving further in the cranial direction, the Waldeyer's fascia was exposed and incised. Full-thickness posterior semicircular flap was fixed to anoderm Receives: Procedure: fistula tract excision and anal sphincter reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
The rate of any symptoms or clinical signs related to recurrence of anorectal fistula: persistent non-healing wound, discharge through the postoperative scar after complete wound healing or an abscess in operation area confirmed with ultrasound or MRI
Measured: 12 months
Secondary outcomes (5)
Operative time
Duration of the operation in minutes
Measured: Day 0
Intraoperative blood loss
The volume of blood lost in the course of the procedure
Measured: Day 0
Pain intensity
The intensity of pain as measured with Visual Analogue Scale (VAS) having 10 grades, with 0 representing no pain and 10 representing the most intensive pain that a person can tolerate.
Measured: postoperative days 1, 3, 7, 14, 28
Anal incontinence score
Evaluated with Cleveland Clinic Florida Fecal Incontinence (CCFFI) score that has 5 questions with 0 to 4 scores assigned to each of them. The total score is calculated, and 0 is referred as no incontinence and 20 - complete incontinence.
Measured: postoperative days 1, 3, 7, 14, 28
Complete wound healing time
The time period between the procedure and the date when complete wound healing was confirmed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Jan 2016
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal FistulaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University
- Responsible party
- Sponsor
- Investigators
- Petr Tsarkov, Prof, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357210
- Sponsor's protocol ID
- 76523
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: fistula tract location, wound size, depth, the presence of exudate, complete/incomplete healing, presence of anal incontinence, fistula recurrence, any complications.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uni-center, Retrospective Observational Study to Compare Outcomes of Fistulectomy With Primary Sphincteroplasty, Advancement Flap and Full-thickness Low Rectum Posterior Mobilization After Excision of a High Recurrent Anorectal Fistula
- ClinicalTrials.gov ID
- NCT04357210
- Acronym / sponsor ID
- 76523
- Conditions
- Anorectal Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 22 Apr 2020 (actual)
- 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.
A retrospective analysis of patients treated for recurrent posterior anorectal fistula, who previously had undergone radical excision of fistula-in-ano, was performed. Three types of surgical reconstruction were compared: fistulectomy with primary sphincteroplasty, muco-muscular advancement flap and full-thickness low rectum posterior semicircular mobilization.
Detailed description
Radical surgical treatment of anorectal fistulas implies removal of the tract, which ideally should be followed by complete wound healing and good anal sphincter function. A big variety of techniques to restore the anal canal after fistula excision have been developed, however, none of them demonstrates excellent results in difficult clinical situations. Treatment of high anorectal fistulas, as well as recurrent fistulas, has always been the most challenging task even for expert colorectal surgeons, considering the need to safely restore the anal sphincters after surgical trauma in the presence of severe postoperative fibrosis and inflammatory changes.
In high recurrent anorectal fistulas, fistulotomy isn't a method of choice as division of a big portion of anal sphincter muscles leads to postoperative incontinence. Muco-muscular advancement flap is an accepted technique for the treatment of high transsphincteric fistulas, showing the best efficacy in unchanged anal canal. Whereas in recurrent disease, due to severe fibrotic deformation of the anal canal, creating an advancement flap can be technically difficult and lead to a complication high rate and postoperative incontinence.
Creation and safe fixation of an endorectal advancement flap (ERAF) in the setting of postoperative fibrosis and perifistular inflammation can be technically difficult. Thus, mobilizing a full-thickness flap is preferred.
After coring out a high transsphincteric or suprasphincteric fistula, the wound from the inside of the anal canal is located close to the anorectal junction, where internal and external anal sphincter fuse with the levator ani muscles. When a full-thickness ERAF is created in this situation, first the surgeon enters the intersphincteric plane, and upward dissection brings him straight to the supralevator space.
This maneuver has much in common with mobilising the distal part of rectum as a part of intersphincteric resections or transanal mesorectal excision for rectal cancer [35] , [36] . After the upper part of the rectum has been mobilized, a surgeon from the perineal team makes a circular incision of the anal canal above the dentate line, enters the intersphincteric space and continues dissection in cranial direction following the surface of the mesorectal fascia, thus separating the lower part of mesorectum from the levator ani muscles.
Being an expert in intersphincteric resections, the leading surgeon utilized this approach in three patients after excision of a high recurrent anal fistula. Sphincteroplasty and standard ERAF creation were not possible due to severe fibrosis, so mobilizing the posterior semicircle of the rectum the same way as in intersphincteric rectal resection was deemed to be the last resort in order to close the wound. In fact, a wide well-vascularized posterior ERAF was created. The upward dissection was continued until the Waldeyer's septum was reached and divided to ensure tension-free fixation of the flap in the anal canal.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| primary sphincteroplasty | – | Procedure: fistula tract excision and anal sphincter reconstructionend-to-end primary sphincteroplasty with interrupted sutures |
| muco-muscular advancement flap | – | Procedure: fistula tract excision and anal sphincter reconstructionA U-shaped muco-muscular flap was mobilized and fixed to the anoderm with one-row interrupted absorbable sutures |
| full-thickness low rectum posterior semicircular mobilization | – | Procedure: fistula tract excision and anal sphincter reconstructionProximal parts of the internal sphincter and the longitudinal muscle were carefully separated from the underlying external sphincter and puborectalis muscle, moving further in the cranial direction, the Waldeyer's fascia was exposed and incised. Full-thickness posterior semicircular flap was fixed to anoderm |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women with high recurrent posteriorly located anorectal fistulas
Key inclusion criteria (4 listed)
- recurrent posterior anorectal fistula
- previously had undergone radical excision
- contrast-enhanced MRI performed preoperatively
- colonoscopy preoperatively
Key exclusion criteria (4 listed)
- Crohn's disease
- superficial fistulas
- low intersphincteric fistulas
- infections (anorectal sepsis, tuberculosis, HIV)
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 |
|---|---|---|
| fistula tract excision and anal sphincter reconstructionThe primary fistulous tract was excised together with any secondary tracts or residual cavities. Then on of the reconstructive steps was performed | Procedure or surgery | full-thickness low rectum posterior semicircular mobilization, muco-muscular advancement flap, primary sphincteroplasty |
Primary outcome
Recurrence rate
Time frame: 12 months
The rate of any symptoms or clinical signs related to recurrence of anorectal fistula: persistent non-healing wound, discharge through the postoperative scar after complete wound healing or an abscess in operation area confirmed with ultrasound or MRI
5 secondary outcomes
Operative time
Time frame: Day 0
Intraoperative blood loss
Time frame: Day 0
Pain intensity
Time frame: postoperative days 1, 3, 7, 14, 28
Anal incontinence score
Time frame: postoperative days 1, 3, 7, 14, 28
Complete wound healing time
Time frame: 1 year
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 27 Apr 2020.
- Individual participant dataSharing planned: Undecided. fistula tract location, wound size, depth, the presence of exudate, complete/incomplete healing, presence of anal incontinence, fistula recurrence, any complications.
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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.
Petr Tsarkov, Prof study director
Director
Questions about this trial
What is this clinical trial studying?
An observational study of Anorectal Fistula, run by Russian Society of Colorectal Surgeons.
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 4 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 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2020.