Anal Sphincter Reconstruction After High Recurrent Anorectal Fistula Excision
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
1 other identifier
observational
14
0 countries
N/A
Brief 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 rectum posterior semicircular mobilization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2016
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 20, 2020
CompletedFirst Posted
Study publicly available on registry
April 22, 2020
CompletedApril 27, 2020
April 1, 2020
2.3 years
April 20, 2020
April 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
12 months
Secondary Outcomes (5)
Operative time
Day 0
Intraoperative blood loss
Day 0
Pain intensity
postoperative days 1, 3, 7, 14, 28
Anal incontinence score
postoperative days 1, 3, 7, 14, 28
Complete wound healing time
1 year
Study Arms (3)
primary sphincteroplasty
end-to-end primary sphincteroplasty with interrupted sutures
muco-muscular advancement flap
A 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
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
Interventions
The primary fistulous tract was excised together with any secondary tracts or residual cavities. Then on of the reconstructive steps was performed
Eligibility Criteria
Men and women with high recurrent posteriorly located anorectal fistulas
You may qualify if:
- recurrent posterior anorectal fistula
- previously had undergone radical excision
- contrast-enhanced MRI performed preoperatively
- colonoscopy preoperatively
You may not qualify if:
- Crohn's disease
- superficial fistulas
- low intersphincteric fistulas
- infections (anorectal sepsis, tuberculosis, HIV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Petr Tsarkov, Prof
Director
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2020
First Posted
April 22, 2020
Study Start
January 1, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
April 27, 2020
Record last verified: 2020-04