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426 A. Safiyeva
Closing the internal opening is allowed with the laser shrinkage effect. The procedure is conducted similarly in both techniques except the performance of an
advancement flap before the laser application. It is as follows: identification and
localization of the internal opening by the injection of hydrogen peroxide or methylene blue from the external opening, debriding of the fistula tract with a curette,
insertion of a plastic hollow 14F catheter using a guide-wire, and insertion of
400 microns radial-emitting disposable laser fiber into the catheter with its tip
emerging at the internal orifice.
The fiber delivers laser energy homogenously at 360
, and by applying continuous power, the tract is closed while withdrawing it at a speed of 1 mm/s. Depending
on the width of the track, a 980 nm or 1470 nm diode laser, delivering different
wavelengths, could be deployed. The first conveys 13 watts of power, while the
second does 10 W. Giamundo et al. performed FiLaC™ procedure on 35 patients
with cryptoglandular and Crohn’s disease-related fistulae (Orlova et al. 2007).
The overall success rate was 71% during the 20-month follow-up period. No data
on postoperative pain and anismus were reported in 8 patients treated with a 980 nm
diode laser. It may be due to the application of higher energy volumes. For this
reason, the authors estimate that the use of a 1479 nm diode laser for FiLaC™ is
higher than 980 nm. Besides, they suggest the use of a discharge device before the
procedure, which h elps to create a more homogen eous caliber of the tract and helps
to close secondary tracts. Ozturk et al. reported a success rate of 82% during
12 months of follow-up in 50 patients treated with sphincteric and trans-sphincteric
fistulas.
These studies show that this procedure has some advantages. It does not affect
durability that has a controlled hyperthermic effect on tissues, has a short learning
curve, and reduces postoperative hospital stay compared to endoanal progressions or
LIFT. However, it has several shortcomings. It is a “blind” procedure because it is
not possible to visualize directly the fistula tract or any secondary tract, and this can
lead to recurrence. Especially the sphincter requires expensive equipment compared
to other saving methods. The refore, randomized trials comparing FiLaC™ with the
most common sphincter protection procedure are required.
Recently, alternative therapies have been used to manage cryptogenic anal fistulas
to minimize surgery and reduce the likelihood of postoperative fecal retention. These
treatments have involved ligation of the inter-sphincteric fistula tract (the LIFT
procedure) either with or without the deployment of a biosynthetic mesh or fistula
clip closure techniques and a range of endofistular therapies including video-assisted
anal fistula treatment (VAAFT), anal fistula plugs, and a variety of injected biomaterials. The Fistula Laser Closure (FiLaC™) device (Biolitec, Germany) is
another endofistular management method and preliminary results in a small cohort
were previously reported by our team and two other surgical units.
As previously described, the FiLaC™ technique uses a disposable laser fiber that
radially radiates for endofistular therapy and, in selected cases, can be supplemented
with mucosal progression anaplasty to control the opening of the internal fistula.
With other methods including bioprosthetic plugs and adhesions, the pivotal causes
of recurrence of fistulas include loose and untreated domestic angles, insufficient
26 The Laser Treatment of Anal Fistulas 427
drainage of the inter-sphincteric cavity, missed sideways, and/or remnants of fistula
epithelium and granulation tissue. The FiLaC™ technique is designed to destroy
both the crypt gland and the extra epithelial layer of the fistula scar along with the
accidental obliteration of both internal and external fistula cavities, via a photothermal effect. This study introduces an extension of our original pilot study that
analyzed the first 5 years of our experience by applying a nonselective approach to
the management of patients with high anal fistula with the FiLaC™ device.
2 Materials and Methods
In the study approved by the local hospital ethics committee, all patients undergoing
the FiLaC™ procedure expressed their consent. It diagnosed 117 patients treated for
anal fistulae in a single tertiary referral center by one experienced colorec tal surgeon
(AW) between October 2009 and July 2014. Here, Parks classi fication identified
fistulae. Amid the procedure, all patients were preoperatively assessed by clinical
examination and proctosigmoidoscopy and were classified via three-dimensional
(3D) endoanal ultrasonography (B-K Medical, Copenhagen, Denmark) performed
by a sonographer experienced in endoluminal anal ultrasound (AW). Very superficial
fistulae where fistulotomy could be performed without compromising sphincter
function and malignant fistulae were withdrawn from the investigation.
The patient demographic data (age, sex) along with fistula type and information
(where available) concerning prior surgical treatments were collected. A simple
questionnaire was conducted to evaluate the postoperative continence status. In
110 cases, there was initial drainage of an abscess with the removal of sidetracks,
identification of the internal fistula opening, and selective insertion of a seton (where
appropriate) into the core fistula tract using a 2 mm latex vessel loop (Ethiloop
Ethicon Products, Germany) at the initial operation.
Seven patients had a chronic fistula, and the fistula was repaired immediately with
a laser. Before making an accurate fistula with the FiLaC™ device, all patients took
the mechanical bowel preparation with 3 L Oralav
®
(Macrogol, B. Braun Melsungen
AG, Germany) and received 2 g of intravenous cefuroxime, 500 mg of metronidazole, and tw o more doses of metronidazole within 24 h after surgery. Surgical steps
of the fistula repair by laser are shown in Figs. 1, 2, and 3.
At the beginning of each therapy, the external and internal cavities of the fistula
were removed, and then a flap was prepared. Depending on the condition of the local
tissue in the internal opening area, either a progression, mucosal, or anodermal flap
was performed. The fistula scar was cleaned mechanically using a curette and saline
irrigation. The internal opening of the sphincter muscle was closed with a 2/0 Vicryl
© suture, and a laser probe was placed after the perineal opening.
For supra-sphincteric type 3 fistulas, a probe was inserted primarily from the
internal cavity to reach the “ turning point” of the fistula pathway to close the transmuscular fistula component. The internal opening was then closed using 2/0
Vicryl©, and the subcutaneous portion of the fistula pathway was laser-treated
from the external opening as described above.
®
,
428 A. Safiyeva
Fig. 1 The fistula tract resulted from a previously drained perianal abscess with seton placement;
the fistula tract was curetted (a ); a hollow thin tube was introduced along the fistula tract (b), helping
the placement of the laser probe through the fistula tract (c)
Fig. 2 The laser probe was dragged along the fistula tract (a) until it came out of the internal
opening (b); then, with the laser fistula probe at the internal opening, the laser delivery system was
switched on (c)
Fig. 3 The laser energy was delivered along with the entire fistula tract (a) up to reach the external
opening (b). Finally, the burned skin at the external opening was removed (c)
The laser probe was inserted through the perineal fistula opening using either a
“Ceralas©” (or recently, a “Leonardo DUAL 45©”) diode laser (Biolitec AG,
Germany). This type of laser conveys energy at a wavelength of 1470 mm (Fig. 1)
and provides an optimal absorption curve in water to resul t in a more efficient local
tissue shrinkage and protein denaturation. When there is no longer any water in the
tissue and the temperature is 100
C above, a white smoke vaporization effect is
26 The Laser Treatment of Anal Fistulas 429
released out. The use of this wavelength by the radial-tip laser fiber allows the
destruction of the granulation and epithelial tissue, which leads to a 2 to 3 mm zone
of controlled tissue damage with less power (13 W) and a diminished likelihood of
perifistular collateral thermal damage. In those supra-sphincteric (Parks type 3)
fistulae, the laser probe is introduced through the internal fistula opening achieving
the “turning point” of the fistula track to obliterate the inter-sphincteric component.
For removal, the fistula tract is treated with a continuous slow retraction of the laser
fiber extracted at a rate of approximately 1 cm per 3 s (Fig. 2). The course of
treatment is mainly assessed with a laser fiber or a metal fistula probe. Ostensibly,
an excessive burning or a protein denaturation of the treated and surrounding tissues
should be prevented. The internal opening was closed using a 2/0 Vicryl © suture
that formed either a mucosal progression or an anodermal flap, depending on the
local tissue condition.
3 Conclusion
To date, various procedures that can be used to treat fistulas have been approved,
indicating the variable complexity of anal fistula and its unpredictable consequences.
Within the last years, different scientists and scholars have scrutinized the methods
in the treatment of anal fistulas for recurrence of anal fistulas and the degree of anal
sphincter insufficiency. Since the beginning of the twenty-first century, there has
been an increasing trend in the treatment of anal fistulas to be less traumatic, shorter
inpatient periods, and preferred to surgical procedures that serve early recovery of
working capacity. In the treatment of anal fistulas, a new technique was developed
using a newly invented radial emitting laser probe (“FiLaC™,” Biolitec, Germany)
to eliminate the fistula epithelium and the remaining fistula trace. The FiLaC™
technique is designed to destroy both the crypt gland and the extra epithelial layer of
the fistula scar along with the accidental obliteration of both internal and external
fistula cavities, via a photothermal effect. To conclude, the study introduced an
extension of our original pilot study that analyzed the first 5 years of our experience
by applying a nonselective approach to the management of patients with high anal
fistula with the FiLaC™ device.
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Treatment by Over-the-Scope-Clip
27
Ruediger L. Prosst
Contents
1 Introduction . ............... .................................................................. 434
2 Technical Background ....................................................................... 434
3 Surgical Application ..................................................... .................... 435
4 Principle of Action .................... ................................... ................... 438
5 Clinical Data ....... .......................................................................... 439
6 The Over-The-Scope-Clip (OTSC Proctology): Discussion and Conclusions ..... .. ... .. 445
References ............................ ............................................... ............ 448
Abstract
The Over-The-Scope-Clip (OTSC Proctology) is part of the novel armamentar-
ium for the treatment for complicated and complex anorectal fistulas, which is
based on high-technology devices. OTSC Proctology consists of an elastic
Nitinol clip and of a stapler-like clip applicator. If the clip is transanally applied
on the internal fistula opening, and the clip closes and seals the orifice, leading to
the healing of the fistula. In the hands of experienced rectal surgeons, OTSC
Proctology is an intuitive surgical instrument which allows a sphincter-preserving
minimally invasive fistula operation. The patient’s subjective burden and postop-
erative pain after clip surgery is relatively low leading to a short hospitalization
and recovery time. The experiences gained with clip procedure in many interna-
tional centers so far demonstrates that it is feasible, safe, and effective and renders
reproducible data. The clip shows favorable results especiall y in cryptoglandular
fistulas and when OTSC is used as a first-line treatment. OTSC Proctology has
proven not only to be a “salvage technique” or “plan B” after the failure of other
fistula procedures. The technique can repeatedly be used without causing major
tissue damage or hamper other surgical interventions. The re is reason to believe
that the combination of the clip with other modern surgical techniques with a
R. L. Prosst (*)
Proctological Institute Stuttgart, Stuttgart, Germany
e-mail: ruediger@prosst.de
© Springer Nature Switzerland AG 2022
C. Ratto et al. (eds.), Anal Fistula and Abscess, Coloproctology,
https://doi.org/10.1007/978-3-030-76670-2_29
433
434 R. L. Prosst
different principle of fistula healing, such as VAAFT or FiLaC, may have a
beneficial synergistic effect.
Keywords
Over-The-Scope-Clip · OTSC Proctology · Clip · Nitinol
1 Introduction
Anorectal fistulas still represent a troublesome condition for both the surgeon and the
patient. The surgical treatment of these fistulas is a delicate balance between their
complete eradication and preservation of fecal continence. Unfortunately, some of
the classical operative techniques, such as advancement flaps or fistulectomy with
primary sphincter reconstruction, are associated with a certain sphincter damage in
the long term, which should not be underestimated. Therefore, various sphincterpreserving strategies, among them the Over-The-Scope-Clip (OTSC Proctology,
Ovesco Endoscopy AG, Tuebingen, Germany), have been developed over the last
decade to overcome these potential problems.
2 Technical Background
The OTSC Proctology system is a surgical device for transanal anorectal fistula
closure, which consists of a clip (Fig. 1) and a clip applicator (Fig. 2). The clip is
14 mm in diameter and made of Nitinol which is a super-elastic shape memory alloy.
It is a biocompatible and MR conditional material and can remain in the body as a
long-term implant. The opened clip is mounted on the tip of the applicator. After
release, the clip retakes its originally closed shape and thus exerts a constant
compression on the tissue between the jaws of the clip. If applied on the internal
fistula opening, the clip closes and seals the orifice with a permanent pressure of
around 8 Newton. This mechanism allows the healing of the fistula by preventing
Fig. 1 The clip of the OTSC
Proctology system is 14 mm
in diameter with pointed teeth
and made of superelastic
shape memory alloy (Nitinol).
(Figures with permission by
Ovesco Endoscopy AG,
Tuebingen, Germany)
27 Treatment by Over-the-Scope-Clip 435
Fig. 2 The OTSC Proctology
system consists of the clip and
the clip applicator. A special
fistula brush and an anchor
device are accessories of the
OTSC Proctology system.
(Figures with permission by
Ovesco Endoscopy AG,
Tuebingen, Germany)
inflowing stool and bacteria into the fistula tract. The space between the teeth of the
clip enables a good microperfusion of the captured tissue and therefore avoids
necrosis and assists healing. A special fistula brush can be used for debridement of
the fistula tract before clip application. A tissue anchor device is an op tional
application aid for the OTSC Proctology system (Fig. 2).
The proctology system is a modification of the endoscopic OTSC system, which
is widely used as a standard procedure in flexible endoscopy for hemostasis and for
the closure of gastrointestinal perforations or anastomotic leaks (Bartell et al. 2020).
A recent meta-analysis reviewed more than 450 publications on endoscopic OTSC
therapy for gastrointestinal hemorrhage, for acute leaks and perforations, as well as
for chronic leaks and fistulas. The analysis revealed high technical succes s rates
(hemorrhage 93.0%; acute leaks/perforations 89.7%; chronic leaks/fistulas 83.8%)
and convincing clinical success rates (hemorrhage 87.5%; acute leaks/perforations
81.4%; chronic leaks/fistulas 63.0%) (Weiland et al. 2020). Endoscopic OTSC has a
variety of other indications, including defect closures to prevent delaye d perforations, e.g., after endoscopic submucosal dissection (ESD), full-thickness resections
(FTR) of subepithelial lesions, stent fixation, and preoperative marking. In addition,
the clip can be used to close the gastrotomy in natural orifice transluminal endoscopic surgery (NOTES). Hence, OTSC is well suited to current endoscopic trends,
and its usefulness has become well defined in therapeutic guidelines.
3 Surgical Application
Surgery with OTSC Proctology follows a standardized operative pathway after the
fistula has been sufficiently drained by a silicon-loop or seton (Fig. 3a, b): it starts
with the circumferential excision of anoderm around the internal opening of the
fistula to obtain an area of exposed internal sphincter muscle measuring approximately 2 cm in diameter (Fig. 4a, b). This step is necessary to avoid that the clip is
applied on the very sensitive anoderm rather than on the stable sphincter muscle. For
fistula preparation the special fistula brush is used to remove all of the granulation
436 R. L. Prosst
Fig. 3 Fistula closure using the OTSC Proctology system. (a and b) preoperative situation with
seton drainage of the fistula. (Figures with permission by Ovesco Endoscopy AG, Tuebingen,
Germany)
Fig. 4 (a and b) Circumferential excision of anoderm around the internal fistula opening.
(Figures with permission by Ovesco Endoscopy AG, Tuebingen, Germany)
tissue and neoepithelium that covers the fistula tract (Fig. 5a, b). Therefore, the seton
for drainage is attached to the lug of the brush for simplified insertion of the brush.
After debridement of the fistula tract, it is rinsed with saline. The shaft of the brush
can be left in place to indicate the internal opening of the fistula. Two resorbable
U-shaped sutures are placed through the sphincter muscle centering the internal
opening of the fistula in a cross-like fashion (Fig. 6a, b). The sutures are knotted at
their distal end and pulled through the working channel of the clip applicator using
the integrated thread retriever (Fig. 7a, b). In case that the fistula cannot be reached
with sutures, the fistula opening can be grasped and pulled using the tissue anchor
device which can be inserted through the working channel of the instrument. By