Anal FistulaSELFNCT04119700
Fistulectomy and Primary Sphincter rEconstruction vs. endorectaL Advancement Flap in the Treatment of High Anal Fistulas
A study testing Muco-muscular endorectal advancement flap after fistulectomy and Primary sphincter reconstruction after fistulectomy in people with Anal Fistula, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
Trial summary
The optimal method of surgical treatment of complex anorectal fistulas has not been found yet. The aim of this study is to compare two techniques in treatment of high anorectal fistulas. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Muco-muscular endorectal advancement flap after fistulectomy and Primary sphincter reconstruction after fistulectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteRussia
- Study dates
- 4 Nov 2017to 7 Mar 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's consent to participate in the study
- Patient's consent for surgery
- High transsphincteric anorectal fistula, involving from 1/3 to 2/3 of the height of the sphincter according to the both MRI and intraoperative revision
- Cryptoglandular fistulas
- The absence of incontinence before the operation in accordance with the classification CCFF-IS
- Preoperative MR-diagnostics before the operation
Who cannot join
- Refuse of the patient to participate in the study.
- Low transsphincteric (involving less than 1/3 of the height of the sphincter according to MRI), intersphincteric, extrasphincteric fistula of the rectum.
- Recurrent fistula.
- Rectovaginal or rectourethral fistula.
- Anal incontinence (Appendix 2).
- Pregnancy.
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- Inflammatory bowel disease (confirmed endoscopically and morphologically).
- Patients with immunodepression (i.e. HIV)
- The presence of an acute purulent process in the perianal area.
- Anterior anorectal fistula in female.
- The inability to perform MRI of the pelvic organs.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Clinic of Colorectal and Minimally Invasive Surgery
Moscow, 119435
Yuliia Churina, MD, +79154970361, churina.1238@mail.ru
Petr Tsarkov, Prof.
About this study
Official title: Fistulectomy With Primary Sphincter Reconstruction vs. Muco-muscular Endorectal Advancement Flap in the Treatment of High Transsphincteric Anal Fistulas
The optimal method of surgical treatment of complex anorectal fistulas has not been found yet.
The aim of this study is to compare two techniques in treatment of high anorectal fistulas. This study purpose to demonstrate that the fistulectomy with dissection from 1/3 to 2/3 of the height of the sphincter complex with primary suturing is technically simpler, equally effective and safe in comparison with muco-muscular endorectal advancement flap.
Read the detailed description
Anorectal fistula is a common proctological disease with prevalence between 8.6 and 10 per 100,000 population. Surgical treatment of complex anorectal fistulas has two main objectives: preventing the recurrence of the disease and preserving the anal continence. The optimal principle of management of patients with anorectal fistulas includes a comprehensive preoperative examination with the definition of the architectonics of the fistulous tract, the identification of the internal fistulous opening, the elimination of additional tracts and cavities.
Many methods are used for high anorectal fistula's treatment, but the optimal strategy has not been found yet.
Nowadays, the conventional sphincter-preserving operation for the treatment of complex anorectal fistulas is advancement rectal flap. In addition, plastic with a full-thickness flap in comparison with a mucosal flap was associated with less reccurence rate (10% and 40% respectively), and was accompanied by manifestation of incontinence symptoms, increased with the thickness of the flap.
About 20 years ago, in an attempt to reduce high level of incontinence, the primary reconstruction of sphincters after fistulotomy was proposed; however, this technique is still debated.
According to reports, dissection of more than 1/3 of the sphincter increases the incidence of postoperative incontinence. However, fistulectomy with primary suturing of the sphincter defect allows to improve the function of anal continence and is recommended for patients with initial incontinence after previous surgical interventions.
The studie's aim is comparison between two techniques in treatment of high anorectal fistulas. This study purpose to demonstrate that the fistulectomy with dissection from 1/3 to 2/3 of the height of the sphincter complex with primary suturing is technically simpler, equally effective and safe in comparison with muco-muscular endorectal advancement flap.
- Conditions
- Anal Fistula
- Being tested
- Muco-muscular endorectal advancement flap after fistulectomy, Primary sphincter reconstruction after fistulectomy
- Keywords
- fistulectomy, fistula, advancement flap, transsphincteric fistula, sphincteroplasty, primary sphincter reconstruction, high fistula, endorectal flap
- Medical subject headings
- Rectal Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muco-muscular endorectal advancement flap after fistulectomyProcedure or surgery
After fistulectomy muco-muscular flap of the rectal wall will be mobilized. The muscular defect is sutured with separate interrupted sutures (Vicryl / Polysorb 2/0, 0/0, 3/0). The muco-muscular flap is fixed to the anoderm without tension by interrupted sutures (Vicryl / Polysorb 4/0). The wound of the perianal area is not sutured.
Primary sphincter reconstruction after fistulectomyProcedure or surgery
Fistulectomy will be performed. The affected gland is visualized and removed. If there are secondary extensions, they are excised also. Sphincter defect with stitches (suture material Vicryl / Polysorb 2/0, 0/0, 3/0) with restoration of the anal canal profile (suturing of the anodermal-skin border). The skin is not suturing.
| Study group | Role | What they receive |
|---|---|---|
| Muco-muscular endorectal advancement flap | Active comparator | After fistulectomy a muco-muscular endorectal advancement flap is mobilised and fixed to anoderma Receives: Procedure: Muco-muscular endorectal advancement flap after fistulectomy |
| Primary sphincter reconstruction | Experimental | After fistulectomy the defect in anal sphincters is closed Receives: Procedure: Primary sphincter reconstruction after fistulectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence rate
The frequency of incontinence after the operation in accordance with the classification CCFF-IS (Cleveland Clinic Florida Faecal Incontinence Score). 0 points - total continence, 24 points - complete incontinence.
Measured: 1 day - 1 year
Secondary outcomes (4)
Pain intencity
The severity of pain in the postoperative period according to VAS score (visual analogue pain scale). Interpretation of values: no pain (0 points), mild pain (1-4 points), moderate pain (5-9 points), severe pain (10 points).
Measured: 1 day, 7 day, 14 day, 30 day
Recurrence rate
The frequency of recurrence of the disease in the comparison groups during the observation period.
Measured: 1 day - 1 year
Wound healing
The duration of wound healing in the perianal area and anus
Measured: 30 day - 90 day
Overall quality of life
Assessed with patient-reported questionnaire SF-36 (Short-form 36 Questionnaire). A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disabilityusing the SF-36 questionnaire.
Measured: assessed after surgery: 14 day, 1 month, 3 month, 6 month, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start4 Nov 2017
- Primary completion20 Feb 2020 (estimated)
- Study completion7 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petr Tsarkov, Prof, Principal investigator, Russian Society of Colorectal Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119700
- Sponsor's protocol ID
- 070819
- Acronym
- SELF
- Status last verified
- Feb 2020
- First submitted
- 6 Oct 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fistulectomy With Primary Sphincter Reconstruction vs. Muco-muscular Endorectal Advancement Flap in the Treatment of High Transsphincteric Anal Fistulas
- ClinicalTrials.gov ID
- NCT04119700
- Acronym / sponsor ID
- SELF / 070819
- Conditions
- Anal Fistula
- Keywords
- fistulectomy, fistula, advancement flap, transsphincteric fistula, sphincteroplasty, primary sphincter reconstruction, high fistula, endorectal flap
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Study start
- 4 Nov 2017 (actual)
- Primary completion
- 20 Feb 2020 (estimated)
- Study completion
- 7 Mar 2020 (estimated)
- First posted
- 8 Oct 2019 (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.
The optimal method of surgical treatment of complex anorectal fistulas has not been found yet.
The aim of this study is to compare two techniques in treatment of high anorectal fistulas. This study purpose to demonstrate that the fistulectomy with dissection from 1/3 to 2/3 of the height of the sphincter complex with primary suturing is technically simpler, equally effective and safe in comparison with muco-muscular endorectal advancement flap.
Detailed description
Anorectal fistula is a common proctological disease with prevalence between 8.6 and 10 per 100,000 population. Surgical treatment of complex anorectal fistulas has two main objectives: preventing the recurrence of the disease and preserving the anal continence. The optimal principle of management of patients with anorectal fistulas includes a comprehensive preoperative examination with the definition of the architectonics of the fistulous tract, the identification of the internal fistulous opening, the elimination of additional tracts and cavities.
Many methods are used for high anorectal fistula's treatment, but the optimal strategy has not been found yet.
Nowadays, the conventional sphincter-preserving operation for the treatment of complex anorectal fistulas is advancement rectal flap. In addition, plastic with a full-thickness flap in comparison with a mucosal flap was associated with less reccurence rate (10% and 40% respectively), and was accompanied by manifestation of incontinence symptoms, increased with the thickness of the flap.
About 20 years ago, in an attempt to reduce high level of incontinence, the primary reconstruction of sphincters after fistulotomy was proposed; however, this technique is still debated.
According to reports, dissection of more than 1/3 of the sphincter increases the incidence of postoperative incontinence. However, fistulectomy with primary suturing of the sphincter defect allows to improve the function of anal continence and is recommended for patients with initial incontinence after previous surgical interventions.
The studie's aim is comparison between two techniques in treatment of high anorectal fistulas. This study purpose to demonstrate that the fistulectomy with dissection from 1/3 to 2/3 of the height of the sphincter complex with primary suturing is technically simpler, equally effective and safe in comparison with muco-muscular endorectal advancement flap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muco-muscular endorectal advancement flap | Active comparator | Procedure: Muco-muscular endorectal advancement flap after fistulectomyAfter fistulectomy a muco-muscular endorectal advancement flap is mobilised and fixed to anoderma |
| Primary sphincter reconstruction | Experimental | Procedure: Primary sphincter reconstruction after fistulectomyAfter fistulectomy the defect in anal sphincters is closed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient's consent to participate in the study
- Patient's consent for surgery
- High transsphincteric anorectal fistula, involving from 1/3 to 2/3 of the height of the sphincter according to the both MRI and intraoperative revision
- Cryptoglandular fistulas
- The absence of incontinence before the operation in accordance with the classification CCFF-IS
Key exclusion criteria (11 listed)
- Refuse of the patient to participate in the study.
- Low transsphincteric (involving less than 1/3 of the height of the sphincter according to MRI), intersphincteric, extrasphincteric fistula of the rectum.
- Recurrent fistula.
- Rectovaginal or rectourethral fistula.
- Anal incontinence (Appendix 2).
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 |
|---|---|---|
| Muco-muscular endorectal advancement flap after fistulectomyAfter fistulectomy muco-muscular flap of the rectal wall will be mobilized. The muscular defect is sutured with separate interrupted sutures (Vicryl / Polysorb 2/0, 0/0, 3/0). The muco-muscular flap is fixed to the anoderm without tension by interrupted sutures (Vicryl / Polysorb 4/0). The wound of the perianal area is not sutured. | Procedure or surgery | Muco-muscular endorectal advancement flap |
| Primary sphincter reconstruction after fistulectomyFistulectomy will be performed. The affected gland is visualized and removed. If there are secondary extensions, they are excised also. Sphincter defect with stitches (suture material Vicryl / Polysorb 2/0, 0/0, 3/0) with restoration of the anal canal profile (suturing of the anodermal-skin border). The skin is not suturing. | Procedure or surgery | Primary sphincter reconstruction |
Primary outcome
Incontinence rate
Time frame: 1 day - 1 year
The frequency of incontinence after the operation in accordance with the classification CCFF-IS (Cleveland Clinic Florida Faecal Incontinence Score). 0 points - total continence, 24 points - complete incontinence.
4 secondary outcomes
Pain intencity
Time frame: 1 day, 7 day, 14 day, 30 day
Recurrence rate
Time frame: 1 day - 1 year
Wound healing
Time frame: 30 day - 90 day
Overall quality of life
Time frame: assessed after surgery: 14 day, 1 month, 3 month, 6 month, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
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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 principal investigator
Russian Society of Colorectal Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muco-muscular endorectal advancement flap after fistulectomy and Primary sphincter reconstruction after fistulectomy in people with Anal Fistula, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Feb 2020. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuliia Churina, MD (+79154970361, churina.1238@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence rate (time frame: 1 day - 1 year). 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 28 Feb 2020.