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

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.

Study Overview

• Status: Completed
• Conditions: Anorectal Fistula
• Intervention / Treatment: Procedure: fistula tract excision and anal sphincter reconstruction

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 Type: Observational
• Enrollment (Actual): 14

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Men and women with high recurrent posteriorly located anorectal fistulas

Description

Inclusion Criteria:

• recurrent posterior anorectal fistula
• previously had undergone radical excision
• contrast-enhanced MRI performed preoperatively
• colonoscopy preoperatively

Exclusion Criteria:

• Crohn's disease
• superficial fistulas
• low intersphincteric fistulas
• infections (anorectal sepsis, tuberculosis, HIV)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
primary sphincteroplasty; end-to-end primary sphincteroplasty with interrupted sutures	Procedure: fistula tract excision and anal sphincter reconstruction; The primary fistulous tract was excised together with any secondary tracts or residual cavities. Then on of the reconstructive steps was performed
muco-muscular advancement flap; A U-shaped muco-muscular flap was mobilized and fixed to the anoderm with one-row interrupted absorbable sutures	Procedure: fistula tract excision and anal sphincter reconstruction; The primary fistulous tract was excised together with any secondary tracts or residual cavities. Then on of the reconstructive steps was performed
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	Procedure: fistula tract excision and anal sphincter reconstruction; The primary fistulous tract was excised together with any secondary tracts or residual cavities. Then on of the reconstructive steps was performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Duration of the operation in minutes	Day 0
Intraoperative blood loss	The volume of blood lost in the course of the procedure	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.	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.	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.	1 year

Collaborators and Investigators

• Sponsor: Russian Society of Colorectal Surgeons
• Collaborators: I.M. Sechenov First Moscow State Medical University
• Investigators: Study Director: Petr Tsarkov, Prof, Director

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: 76523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: fistula tract location, wound size, depth, the presence of exudate, complete/incomplete healing, presence of anal incontinence, fistula recurrence, any complications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No