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Comparison of Laser Ablation and Fistulectomy with Sphincteroplasty for the


Management of Transsphincteric Fistulas Following Preliminary Seton
Insertion

Article in Ain Shams Journal of Surgery · April 2023


DOI: 10.21608/ASJS.2023.298768

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DOI: 10.21608/ASJS.2023.298768

Comparison of Laser Ablation and Fistulectomy with Sphincteroplasty


for the Management of Transsphincteric Fistulas Following Preliminary
Seton Insertion
Ehab H. Abd El-Wahab, MD; Mohammad Ahmad Abd-erRazik, MRCS, MD, FACS; Kamal Elsaid,
MD
Department of General Surgery, Faculty of Medicine, Ain Shams University, Egypt

Background: Cryptoglandular perianal fistulas are a frequent problem, and the traditional surgical procedure
carries a risk of incontinence and recurrence. The ultimate goal of fistula management is to resolve and prevent
sepsis, eradicate the fistula, prevent recurrence, and ensure continence. Laser Ablation of Fistula Tract (LAFT)
offers a viable alternative sphincter-saving modality.
Patient and methods: In this study, we performed a randomized controlled trial to evaluate the safety and
efficacy of laser ablation as a treatment for transsphincteric fistulas. This study was conducted at Ain Shams
University hospitals from June 2019 to June 2022 and included eighty patients with cryptoglandular transsphincteric
fistulas who had undergone previous drainage and seton, they were divided into two groups. The first group (Group
A) underwent fistulectomy with subsequent sphincteroplasty while the second group (Group B) underwent laser
ablation of the fistula tract. Follow-up was scheduled in the outpatient clinic at 1 and 2 weeks and 1, 3, and 6
months postoperatively. The Cleveland Clinic Florida Fecal Incontinence CCF-FI score and the visual analog scale
(VAS) score were recorded at each visit.
Results: The results of the study showed that the laser ablation of the fistula track technique is a safe and effective
sphincter-saving modality for transsphincteric fistula management with acceptable healing rates. The technique
also carries the advantages of a short learning curve, reduced hospital stay, and minimal risk of incontinence.
Conclusion: Our study found that laser ablation is a safe and effective treatment option for transsphincteric
fistulas. Preliminary seton insertion may have a positive impact on postoperative outcome. However, there is a need
for further research to evaluate the long-term outcomes..
Key words: Anal fistulas, laser ablation, fistulectomy, transsphincteric fistulas, incontinence.

Introduction definitive surgery, despite recent advancements in


surgical techniques, such as the anal fistula plug
Anal fistula disease (AF) is a condition with a and fibrin glue. The main reasons for recurrence
long history, with evidence of its existence found include missing or untreated internal openings,
in the ancient medical literature. The reported incomplete drainage of the intersphincteric space,
incidence of AF in the European Union ranges from missed sidetracks, and persistence of the primary
10.4 per 100,000 in Spain to 23.2 per 100,000 in track.4
Italy. Historically, the main treatment for AF was
fistulotomy, fistulectomy, or the use of a seton. Complete excision of the fistula with sphincteroplasty
However, these treatments often resulted in has resulted in acceptable healing outcomes, but
defective continence, particularly in patients with the main drawback of this technique is incontinence,
high transsphincteric fistulas.1 which occurs in up to 20% of cases.4 The challenge
of treating cryptoglandular perianal fistulas while
The goal of surgical management for AF is to resolve preserving anal sphincter function remains. Despite
and prevent sepsis, eradicate the fistula, prevent the development of various new techniques, a
recurrence, and ensure continence. However, perfect treatment that leads to convenient healing
these goals can sometimes be in conflict, making it rates while preserving sphincter function has not
difficult to achieve an acceptable balance. This has yet been discovered.
led to the development of new strategies to improve
current techniques.2 Laser Ablation of Fistula Tract (LAFT) was introduced
in 2011 as a new technique with high potential.
Historically, seton placement was the main method The LAFT involves the use of a radial emitting laser
of surgical management for most perianal fistulas. probe (E.g., “FiLaC™”, Biolitec, Germany) to ablate
Setons allow the drainage of associated abscesses the fistula tract. The removal of granulation tissue
while promoting the resolution of the tract through from the tract allows for the healing of the tissues
a local inflammatory process.3 However, persistent and preservation of continence. Initial results have
fistulas occur in up to 30% of patients after shown acceptable primary healing rates without

Ain-Shams J Surg 2023; 16 (2):163-171 163


impairment of continence, with sustained results
after long-term follow-up.5

Patients and methods

This study is a prospective randomized controlled


trial that was conducted at Ain Shams University
hospitals from June 2019 to June 2022. It included
80 patients with cryptoglandular transsphincteric
fistula who had undergone previous drainage and
seton placement.

The patients were randomly allocated into two


groups: Group A underwent fistulectomy with
subsequent sphincteroplasty, while Group B
underwent laser ablation of the fistula tract. Both
groups had 40 patients each. Exclusion criteria
included superficial fistulas that could be managed
by fistulotomy without affecting anal sphincter
function and any fistulas related to inflammatory
bowel diseases or malignancy. Approval from the
ethical committee was granted and informed
consent to undergo the surgical intervention was Fig 1: The sphincter is identified and held by
signed out by all patients. Patients agreed to Vicryl® 2-0 sutures.
participate in regular follow-up visits.
Starting from the proximal part of the cut sphincter,
The primary operation involved drainage of perianal the repair proceeds using polydioxanone 3-0
abscesses (If present), clearance of sidetracks, and interrupted sutures starting from the outer to the
seton drainage of the main fistula track using a 2 inner side of the sphincter, then from the inner to
mm silicone vessel loop. the outer aspect in a U-shaped manner tying both
ends in a firm secure knot placed at the outer aspect
Prior to the definitive procedure, all patients of the repaired sphincter. Through progressive deep
underwent routine preoperative clinical assessment bites the entire sphincter is progressively repaired.
and examination, including assessments of The remaining part of the wound is left open for
incontinence history. Magnetic resonance imaging good wound drainage (Figure 2).
(MRI) was done routinely for all patients, and if
continence was questioned, anorectal manometry
and endoanal ultrasound were performed.

All patients received antibiotics (Cephalosporins and


metronidazole) prior to the procedure and were
placed under general anesthesia in the lithotomy
position. An anal examination was performed,
and anal retractor was inserted. After adequate
mobilization, the seton tie was cut and the distal
part of the track and the external opening of the
fistula were excised. Afterward, the remaining part
of the track was cleaned, curetted, and irrigated
with saline.

In Group A, end-to-end sphincter repair was


performed, taking into consideration not to leave
any dead space deep to the repaired sphincter
muscle. To facilitate the repair, the sphincter muscle
was mobilized from the skin and the external
ischioanal fat. The sphincter muscle was identified
and held by applying Vicryl® 2-0 stay sutures on
each side (Figure 1). Fig 2: Complete repair of the sphincter muscles
after fistulectomy.

In Group B, laser ablation of the fistula tract was


conducted using a 1470-nm diameter laser fiber and
the Ceralas ® platform (Biolitec AG, Jena, Germany),

164 Ain-Shams J Surg 2023; 16 (2):163-171


(Figures 3,4). The laser probe was inserted from
the external opening emerging from the internal
opening guided by the previously inserted seton,
(Figures 5-7).

Fig 6: Adequate mobilization of the track.

Fig 3: The (Biolitec AG, Jena, Germany) laser


device.

Fig 7: The laser fiber is successively inserted into


Fig 4: The disposable 1470-nm diameter laser
the fistulous track.
fiber.

By applying a 13-watt energy output, the fistula


track was obliterated using continuous retraction of
the laser fiber at a rate of approximately 1 cm every
7 seconds, then it was advanced back towards
the internal opening. Care was taken during the
procedure to avoid excessive burns to the treated
and surrounding tissue, as well as damage to
adjacent tissues (Figure 8). The previously
identified internal opening was closed using
interrupted Vicryl® sutures (Polyglactin 910, 3-0
needle, 26 mm, 5/8 circle) to ensure proper healing.

Fig 5: Careful examination of the previously


inserted seton in the fistulous track.

Ain-Shams J Surg 2023; 16 (2):163-171 165


(Version 19). The results were presented as mean
and standard deviation, frequency, or proportion.
To compare the results between the groups, the
Student’s t-test (For normally distributed data), the
Chi-square test (for categorical variables), and the
percentage comparison method were used. The
hypotheses were either two-tailed or one-tailed,
and statistical significance was set at p < 0.05.

Results

This prospective randomized controlled


study includes eighty patients presented with
transphincteric anal fistula who was primarily
treated with drainage and seton placement which
were randomly allocated into two groups, each
group consists of forty patients. The first group
(Group A) underwent fistulectomy followed by
sphincteroplasty while the other group underwent
Fig 8: The fistulous track after successful
ablation.
laser ablation of the fistulous tract. No significant
statistical differences were noted regarding patient’s
age, sex, and risk factors including smoking
and diabetes mellitus. No significant statistical
Patients were discharged with a prescription differences was found regarding the time interval
for simple analgesia, oral cephalosporins, and between the definitive intervention and preliminary
metronidazole. Patients who underwent sphincter seton insertion. Patient’s characteristics were shown
repair were advised to avoid straining and to limit in (Table 1).
physical activity for four to eight weeks. All patients
were instructed on proper wound care, including There was a clear significancant statistical difference
adequate cleaning the wound and applying local regarding mean operative time which was clearly
antibiotic cream after defecation and before shorter in laser ablation group (P value 0.000).The
bedtime. mean hospital stay was shorter in the laser ablation
group with statistical significance (P value 0.000)
Follow-up visits were scheduled for the outpatient (Table 2).
clinic at 1 and 2 weeks, as well as 1, 3, and 6
months post-surgery. However, patients were Postoperative pain was assessed using VAS score
instructed to return to the clinic at any time if they in the first day, first and second week. Statistical
experienced any symptoms. The Cleveland Clinic significance difference regarding the mean VAS
Florida Fecal Incontinence (CCF-FI) score and the scores was found in favor of the laser ablation group
Visual Analogue Scale (VAS) score (To measure (Table 3).
pain) were evaluated during each visit. Any signs of
recurrence were closely monitored through clinical Analysis of the postoperative complications revealed
examination and MRI. The patient was considered no statistical significant difference between both
cured if the external and internal openings were groups. Recurrence was higher in laser ablation
closed, with no discharge, pain, or swelling present. group with statistical significance (P value 0.002)
Treatment was considered a failure if the external while the median time for healing was shorter in
opening remained unclosed at the three-month laser ablation group with statistical significance (P
follow-up. value 0.000) (Table 4).

Statistical analyses were conducted using SPSS, Postoperative continence was carefully assessed and
IBM. Corp, USA (Version 26.0), and MINITAB, USA recorded using CCF score. No significant statistical
difference was found in both groups.

166 Ain-Shams J Surg 2023; 16 (2):163-171


Table 1: Patients characteristics
Group B
Fistulectomy and Statistical
Laser ablation of P value
sphincterolplasty significance
fistulous tract
Number of patients 40 40
Median age 34.5 34.00 0.958 No significance difference
Gender (M:F) (28:12) (26:14) 0.633 No significance difference
Smoking 12 (30%) 14 (35%) 0.633 No significance difference
Diabetes Mellitus 8 (20%) 9 (22.5%) 0.785 No significance difference
Median time between seton placement
14.50 14.00 0.194 No significance difference
and definitive intervention

Table 2: Mean operative time and mean hospital stay in both groups
Group A Group B
Statistical
Fistulectomy and Laser ablation of P value
significance
sphincterolplasty fistulous tracr
Mean operative time 47.025 37.750 0.000 Significance difference
Mean hospital stay 2.00 1.08 0.000 Significance difference

Table 3: Vas scores in the first, first and second week in both groups
Group A Group B
Statistical
Mean VAS score Fistulectomy and Laser ablation of P value
significance
sphincterolplasty fistulous tract
First day 5.18 3.88 0.000 Significance difference
First week 3.85 2.4 0.000 Significance difference
Second Week 2.02 1.5 0.001 Significance difference

Table 4: Post-operative outcomes in both groups


Post-operative Group A Group B
Statistical
complications And Fistulectomy and Laser ablation of P value
significance
outcome sphincterolplasty fistulous tract
Bleeding 2 (5%) 1 (2.5%) 0.555 No significance difference
Urinary retention 4 (10%) 2 (5%) 0.394 No significance difference
Infection 1 (2.5%) 0 0.311 No significance difference
Recurrence 2 (5%) 12 (30%) 0.002 significance difference
Median time for healing 8 6 0.000 Significance difference

Table 5: Postoperative CCF score assessment


Group A Group B
Statistical
Fistulectomy and Laser ablation of P value
significance
sphincterolplasty fistulous tract
(0) 92.5% (0) 95%

First Month (1) 5% (1) 5% 0.630 No significance difference

(2) 2.5%
(0) 97.5% (0) 100%
Second month 0.317 No significance difference
(1) 2.5%

Ain-Shams J Surg 2023; 16 (2):163-171 167


Discussion with an incontinence rate of 3.6% and a recurrence
rate of 3.6%.11
Complex perianal fistulas can be a challenging
condition to treat, as the goal is to achieve successful The laser emitted by the radial-tip fiber into the
fistula closure while also maintaining continence and fistula track is capable of eliminating the endoluminal
patient satisfaction. There have been various surgical granulation tissue and the epithelium of the fistula
techniques proposed for sphincter-preserving fistula tract due to its shrinkage effect, which is similar to
repair, but many of these techniques have not that observed in the treatment of varicose veins.
resulted in sustained long-term success.6,7 Reasons This is in contrast to simple diathermy, which cannot
for recurrence may include persistent or recurrent achieve the same effect, and is less easily controlled,
disease from the internal opening, inadequate particularly with regard to thermal damage on the
drainage of the intersphincteric space, and sphincter muscle.8
sidetracks that are frequently missed. As a result,
when patients present with perianal abscesses or Wilhelm conducted a pilot study of eleven patients
persistent fistulas, appropriate primary surgery presented with cryptoglandular type (1-4) fistulas
must be performed. Evacuation of abscesses, who had undergone previous surgery for perianal
excision of secondary tracks, and drainage of the abscess and fistula with seton insertions. After the
intersphincteric space are crucial.4 closure of the internal opening with either a mucosal
or anodermic flap, a laser probe with a wavelength
The seton placement promotes continuous drainage of 1,470 nm and 13-Watt energy was used to
of the fistula track to minimize infection but can obliterate the track. Primary healing occurred in
lead to recurrence from epithelial remnants or 81.8% of patients after a median follow-up of 7.4
granulation tissue. Fistula laser closure (FiLaC™) months, with no major or minor complications
is a promising technique that uses diode laser reported. Wilhelm continued to use the technique
energy, via a flexible radial fiber, to shrink the fistula in the management of high anal fistulae in an
tract and achieve primary closure. But it has the unselected patient population over the next five
drawback of not being able to visualize the tract years.4,12
and the potential to damage the sphincter if high
powers were used.4 The use of a draining seton A study was conducted involving 117 patients with a
with laser treatment may help to achieve complete median follow-up period of 25.4 months. Two types
shrinkage of the fistula tract.8 of diode laser devices, “Ceralas®” and “Leonardo
DUAL 4®” were used. The majority of patients,
Seyfried et al. conducted a study on 424 patients 113 (96.6%), had previously undergone surgery
who underwent fistulectomy and primary sphincter such as abscess drainage and fistula operations.
repair, reporting a primary healing rate of 88.2% In 99 patients (84.6%), a seton was placed with
and a median postoperative hospitalization of an average period of 16.1 (±29.2) weeks between
three days. However, it should be noted that this seton insertion and fistula treatment.12
patient population only consisted of less than 4.2%
of individuals with high transsphincteric fistulas.9 In the study by Wilhelm et al., it was found that
On the other hand, Arroyo et al. reported on a the use of laser energy at a wavelength of 1470
series of patients with transsphincteric fistulas who nm resulted in more efficient local tissue shrinkage
underwent fistulotomy and sphincter reconstruction. and protein denaturation. This was achieved by
They reported an incontinence rate of 16.6% and the absorption of the laser energy in water, which
recurrent incontinence in 8.5%.10 caused the destruction of the granulation and
epithelial tissue in a controlled manner. The damage
In Ratto et al.’s study, 40.3% of the patients had was limited to a 2-3 mm zone and required less
a seton drainage, followed by a fistulotomy and power 13-Watt while minimizing collateral thermal
end-to-end primary sphincteroplasty. There was no damage to the surrounding tissues.12
statistically significant change in fecal incontinence,
and three out of 72 patients (4.3%) experienced It was reported that the FiLaC™ procedure had a
a recurrence. Similarly, Pearl et al. reported that primary success rate of 64.1% (75/117) with similar
a staged fistulotomy using a seton is a safe and outcomes for both cryptoglandular (63.5%; 66/104)
effective procedure for treating high or complicated and Crohn’s-related (69.2%; 9/13) cases. The
anal fistulas, with an incontinence rate of 5% and a secondary success rate was 88.0% (103/117), with
recurrence rate of 3%.11 no differences observed between cryptoglandular
and Crohn’s-related cases. Additionally, the study
Al-Ozaibi et al. conducted a retrospective study of reported no major forms of incontinence in their
56 patients with transsphincteric and complex anal patients, with minor soiling being observed in only
fistulas, managed preliminarily with a loose seton 5.9% of patients (Three after the primary FiLaC™
followed by fistulectomy and sphincteroplasty. The procedure and four after a repeated second fistula
average healing time was 3.7 weeks (2-8 weeks), surgery).12

168 Ain-Shams J Surg 2023; 16 (2):163-171


Giamundo and colleagues performed the FiLaC™ fistulas, including high intersphincteric, low and
fistula laser closure technique on 35 patients. The high transsphincteric, and suprasphincteric fistulas.
procedure involved sealing the fistula tracks without The median surgery time was 22 minutes and the
any additional steps and no complications occurred healing rates at six-month and one-year follow-ups
during surgery. Some patients experienced urinary were 64.7% and 50%, respectively. There were
retention (5.8%), bleeding (2.8%), and anismus no cases of postoperative bleeding or changes
(17.1%) but the overall success rate was 71.4%. in continence reported and no additional pain
Additionally, none of the patients reported any medication was needed beyond the standard post-
significant changes in their continence.8 operative regimen.6

According to Giamundo et al., the cost of the fistula Terzi and colleagues studied 103 patients with fistula
laser closure technique is higher than other sphincter- disease in a study that evaluated the effectiveness of
saving procedures because of the equipment the laser closure procedure. The average age of the
needed. However, the laser device is portable and patients was 43 years. Out of the 103 patients, 53
has multiple surgical uses, such as treating varicose (52%) had undergone previous surgery for perianal
veins. This allows for multiple specialists to use the fistula repair and 29 (28%) had transsphincteric
equipment in one hospital, which can lower costs. fistulas. The results of the study showed that 41
Additionally, although the cost of laser fibers is patients (40%) experienced complete healing, 38
moderate, it is still less expensive than most fistula (37%) still had persistent drainage with symptoms,
plugs.8 20 (19%) had minor drainage with minor symptoms,
and 4 (4%) had painful symptoms with drainage.15
They found that the fistula laser closure technique
(FiLaC™) is a safe option for treating anal fistulas, Suhardja et al., from their center in Australia,
as it does not require additional surgical procedures evaluated the effectiveness of the fistula laser
to close the internal orifice. The technique has an closure technique FiLaC™ on transsphincteric
acceptable success rate and low complications, fistulas. They determined that FiLaC is a viable
making it a desirable choice for patients with weak option for complex fistulas with benefits such as
sphincters. They recommend using a loose seton to not impacting sphincter function, having a short
prepare the fistula track before the procedure, as learning curve, reducing post-operative hospital
this may improve healing outcomes. Overall, they stay, and having success rates comparable to other
suggest that this technique should be considered as surgical procedures for the management of complex
part of the treatment plan for complex fistulas, as it fistulas.16
preserves continence.8
They proposed that the use of laser ablation to
Wolicki conducted a retrospective study of 83 preserve the sphincter is a viable initial treatment
patients who were treated with Fistula-tract Laser option for complex fistulas, but further evaluation
Closure (FiLaC®), Ceralas® or Leonardo® DUAL 45 of its cost-effectiveness is necessary, particularly in
diode laser for transsphincteric and intersphincteric cases where multiple surgeries may be required due
anal fistulas. The procedure included the closure of to higher recurrence rates.16
the internal orifice using a simple 3-0 Z-stitch and
had a mean follow-up period of 41.99 (± 21.59) In our study, 80 patients with transsphincteric fistulas
months. The results showed that 15.7% of patients who had undergone preliminary seton insertion
had a recurrence, 78.3% had prior abscess drainage were randomly divided into two groups. The first
and seton insertion, and 74.7% experienced primary group underwent fistulectomy with subsequent
healing. 9.6% of patients reported changes in sphincter repair, while the second group underwent
continence, but no major incontinence was reported laser ablation of the fistula tract.
postoperatively.14 Analysis of our results clearly demonstrates a
Lauretta and colleagues conducted a retrospective statistical significance in favor of laser ablation
study on 30 patients with a median age of 52 years procedure in terms of operative time, hospital
who were treated with a laser for transsphincteric stay, postoperative VAS scores, time for complete
anal fistulas. They used a diode laser emitting 12 healing, thus may justify the recorded differences of
watts of energy at a wavelength of 1470 nm. The recurrence rates which were statistically significant
study found that a cure was achieved in 10 patients in favor of fistulectomy and sphicteroplasty. No
(33.3%) and an overall healing rate of 40% (12 out significant statistical difference regarding post-
of 30). Only 4 minor complications occurred, which operative complication and recorded CCF score.
is a rate of 13.3%. No changes in anal continence Laser ablation has a clearly positive impact on
were reported.14 patient’s quality of life which may attract more
attention in further studies. We believe that
Nordholm-Carstensen and colleagues examined progressive improvement in this relatively new
the effectiveness of the FiLaC™ technique in a technique will positively affect the recurrence rate
study of 66 patients with various types of anal especially in the management of this difficult type

Ain-Shams J Surg 2023; 16 (2):163-171 169


of anal fistulas. 2. Ng K, Kwok A, Young C: Factors associated with
healing, reoperation and continence disturbance
Our results regarding staged fistulectomy and in patients following surgery for fistula-in-ano.
sphincteroplasty were compatible with Ratto Colorectal Disease. 2020; 22(12): 2204-2213.
et al, Al-Ozaibi et al in terms of recurrence and
incontinence. Preliminary seton insertion has 3. Kelly M, Heneghan H, McDermott F, Nason G,
positive impact in improving postoperative outcome Freeman C, Martin S, Winter D: The role of
which was quiet obvious comparing our recurrence loose seton in the management of anal fistula:
results with Seyfrid et al and Roig et al series. a multicentre study of 200 patients. Techniques.
Similarly comparing our incontinence results with 2014; 18: 915-919.
Arroyo et al series.
4. Wilhelm A: New technique for sphincter-
In the same manner, our results regarding staged preserving anal fistula repair using a novel
laser ablation were compatible with Wilhelm et radial emitting laser probe. Tech Coloproctol.
al and Giamundo et al regarding recurrence and 2011; 15: 445-449.
incontinence. We suggest that Preliminary seton
improves postoperative recurrence which was 5. Stijns J, Van Loon Y, Clermonts S, Wasowicz D,
obvious comparing our results with Lauretta et al. Zimmerman D: Implementation of laser ablation
of fistula tract (LAFT) for perianal fistulas: Do
The results of this study indicate that laser ablation the results warrant continued application of this
is a promising option for the management of technique? Techniques in Coloproctology. 2019;
complex fistulas. It is less invasive than other 23: 1127-1132.
procedures and has a lower risk of adverse
effects, particularly incontinence, which can have a 6. Nordholm-Carstensen A, Perregaard H, Hagen
significant impact on the quality of life for patients K, Krarup P: Fistula laser closure (FiLaC™) for
with transsphincteric fistulas. However, there are fistula-in-ano—yet another technique with 50%
still some technical considerations that need to be healing rates? International Journal of Colorectal
evaluated in further studies. For example, there Disease. 2021; 36: 1831-1837.
is no consensus on the need to close the internal 7. Gendia AM, Abd-erRazik MA, Hanna HH: Ligation
opening of the fistula. Different studies have used of the intersphincteric fistula tract procedure
different methods, such as the flap technique,4 a and its modifications. Journal of Coloproctology.
Z-stitch,13 and simple sutures,6 for the closure of 2018; 38: 324-336.
the internal opening. However, others suggested no
additional procedure.8 8. Giamundo P, Geraci M, Tibaldi L, Valente M:
Closure of fistula-in-ano with laser – FiLaC™: an
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Our study suggests that laser ablation of the fistula complex disease. Colorectal Dis. 2014; 16(2):
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healing rates and several advantages, such as a reconstruction. Int J Colorectal Dis. 2018; 33:
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