Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_1056_Библиотеки_им_академика_М_И_Перельмана.pdf
27 Treatment by Over-the-Scope-Clip 437
Fig. 5 (a and b) Debridement of the fistula tract using the fistula brush. (Figures with permission
by Ovesco Endoscopy AG, Tuebingen, Germany)
Fig. 6 (a and b) Placement of two U-shaped sutures around the internal fistula opening.
(Figures with permission by Ovesco Endoscopy AG, Tuebingen, Germany)
holding the sutures under slight tension, the preloaded clip applicator is advanced
towards the internal opening of the fistula (Fig. 8). The applicator is aligned in
parallel to the axis of the anal canal to achieve an anatomical orientation of the
curved-shaped clip within the anorectum. The applicator cap with the preloaded clip
is slightly pressed against the exposed sphincter muscle around the opening of the
fistula while lifting the tissue with the sutures. After removal of the safety lock of the
applicator, the clip is released by pulling the trigger on the handle of the clip
applicator: the clip is pushed from the applicator cap to close the internal opening
of the fistula by the clip’s teeth penetrating the sphincter muscle and compressing the
proximal fistula tract (Fig. 9). The complete and tight closure of the internal fistula
438 R. L. Prosst
Fig. 7 (a and b) The knotted sutures were pulled through the working channel of the clip applicator
using the thread retriever. (Figures with permission by Ovesco Endoscopy AG, Tuebingen,
Germany)
Fig. 8 Transanal application of the clip by advancing the clip applicator towards the internal fistula
opening and release of the clip. (Figures with permission by Ovesco Endoscopy AG, Tuebingen,
Germany)
opening is tested by irrigation under slight pressure via the external fistula orifice.
Finally, the external opening of the fistula is cored out by diathermy to accomplish
sufficient drainage (Fig. 10). In case of malposition or dislocation, the clip can be
removed with the aid of a special clip cutter: therefore, the lateral curves of the clip
are cut, and the resulting halves of the clip are extracted (Fig. 11).
4 Principle of Action
If applied on the internal fistula opening, the closed clip compresses the captured
tissue and seals the orifice. This mechanism prevents inflowing stool and bacteria
into the fistula tract field of fistula surgery. In contrast to knotted sutures, which allow
an unintended reopening of the fistula tract, e.g., if the captured tissue shrinks after
surgery or the sutures get loose, the superelastic clip a dapts to any changes of the
tissue and maintains a permanent compression on the internal fistula opening
27 Treatment by Over-the-Scope-Clip 439
Fig. 9 Final clip position
compressing the proximal
fistula tract. (Figures with
permission by Ovesco
Endoscopy AG, Tuebingen,
Germany)
Fig. 10 The external opening
of the fistula is cored out to
accomplish sufficient
drainage. (Figures with
permission by Ovesco
Endoscopy AG, Tuebingen,
Germany)
(Fig. 12). Hence, the clip performs a dynamic closure of the internal fistula opening
rather than a static and therefore potentially inadequate closure like sutures.
5 Clinical Data
In 2012, the first use of OTSC Proctology for the closure of a complex high
transsphincteric anal fistula was reported (Prosst and Ehni 2012). The clinical
follow-up after clip placement demonstrated an uncomplicated postoperative course
with the clip firmly sitting on the internal fistula opening. No unexpected side effects
related to the clip, such as necrosis, ischemia, or pressure ulcers, were noticed around
its application site or at the opposite anorectal wall. The patient reported a tolerable
440 R. L. Prosst
Fig. 11 In case of
malposition or dislocation, the
clip can be removed with the
aid of a special clip cutter:
therefore, the lateral curves of
the clip are cut, and the
resulting halves of the clip are
extracted. (Figures with
permission by Ovesco
Endoscopy AG, Tuebingen,
Germany)
Fig. 12 If applied on the
internal fistula opening, the
closed clip compresses the
captured tissue and seals the
orifice. In contrast to knotted
sutures, which allow an
unintended reopening of the
fistula tract (top right), e.g., if
the captured tissue shrinks
after surgery or the sutures get
loose, the superelastic clip
adapts to any changes of the
tissue and maintains a
permanent compression on the
internal fistula opening
(bottom right). (Figures with
permission by Ovesco
Endoscopy AG, Tuebingen,
Germany)
pressure and discomfort in the anal region without a foreign body sensation, which
was sufficiently reduced by oral analgesics. After the fistula had definitively healed
without any clinical signs of recurrence, the clip could be removed in an outpatient
procedure 8 months after clip placement.
This first case report was followed by a prospective, nonrandomized, bicenter
pilot study on 10, respectively, 20 patients with transsphincteric and suprasphincteric
27 Treatment by Over-the-Scope-Clip 441
cryptoglandular fistulas (Prosst et al. 2013, 2015). There were no intraoperative
technical or surgical complications. Postoperatively, no patient-reported intolerable
pain or a foreign body sensation in the anal region. There were no side effects related
to the clip. At 6 months after surgery, 18 (90%) patients had no clin ical signs or
symptoms of fistula and were considered healed, whereas in 2 cases the fistula
persisted. In 13 (72%) of these 18 patients, the clip was still in place without
problems, whereas in 3 patients, the clip had spontaneously detached. In the two
remaining patients, it was necessary to remove the clip due to discomfort and
delayed wound healing.
In 2016, the results of 100 OTSC Proctology procedures in 96 patients
(55 transsphincteric, 38 suprasphincteric, 2 extrasphincteric, and 5 rectovaginal
fistulas) were published (Prosst and Joos 2016). In all but 11 fistulas (8 Crohn’s
disease, 3 ulcerative colitis), the fistulas were of cryptoglandular origin. The
median operation time was 32 min (range 17–66 min). There were no major
intraoperative technical problems. All patients found the postoperative pain to be
tolerable with standard pain medication. After 6 months of follow-up, the results
of 99 operations were analyzed, since 1 patient was lost during follow-up. Six tyfive percen t of patients ha d no clinical sign s or symptoms of their previous fistula
and were considered healed. When the clip was used as first-line t herapy, the
healing rate was 79%, whereas in rec urrent fistulas the success rate was 26%.
The healing rates of transsphincteric, suprasphincteric, extrasphincteric, and
rectovaginal fistulas were 6 1%, 74%, 100%, and 20%, respectively. Cryptoglandular fistulas rendered a success rate of 67%. In IBD-associated fistulas
(inflammatory bowel disease), e.g., Crohn’s disease, the use of the clip was
helpful in 45% of cases. In six cases, the clip had to be removed du e to failed
fistula healing requiring further surgical treatment. In another six cases, the clip
was explanted due to pain, slight discomfort, clip dislocation, secre tion, and
wound-healing problems. Two patients requested clip removal without subjective
or clinical problems.
Over the last years, there was an increasing number of clinical reports and studies
about OTSC Proctology from others than the developers of the surgical clip procedure (Table 1).
The first was a German retrospective single-center study assessing 10 patients
with refractory fistulas (Mennigen et al. 2015). The etiology of the fistulas was
cryptoglandular in four patients and Crohn’s disease in six patients. Surgery and clip
placement was technically successful in all patients within a median operating time
of 40.5 min (range 24–64 min). Reported postoperative pain was comparable to that
experienced after other types of fistula surgery. Seven patients did not sense the
presence of the clip. However, three patients (30%) had well-tolerable symptoms,
such as slight anal discomfort and soiling. After a median follow-up of 230.5 days
(range 156–523 days), permanent fistula closure was achieved in seven patients
(70%). There were three failures (30%) due to spontaneous clip loss in tw o
cryptoglandular (healing rate 50%) and one Crohn-associated fistula (healing rate
83%). Of the seven patients with successful fistula healing, three underwent clip
removal, and the removal was planned in one patient. In the remaining three patients,
442 R. L. Prosst
Table 1 Publications with the clinical use of OTSC Proctology
Number of
Authors
and year of
publication
Prosst and
Ehni 2012
Prosst et al.
2013, 2015
operations and
types of fistulas
treated
n ¼ 1
Cryptoglandular
recurrent fistula
n ¼ 20
Cryptoglandular
(no IBD, no
recurrent or
anorecto-vaginal
fistulas)
Healing rate
(follow-up)
100%
(FU 8 months)
90%
(FU 6 months)
Postoperative
findings (e.g., pain,
incontinence, soiling)
Tolerable anal
pressure; no foreign
body sensation
No postoperative
pain, late clip
removal due to
painful clip
dislocation (n ¼ 1);
no necrosis,
Major
complications
None
None
ischemia, or pressure
ulceration
Mennigen
et al. 2015
n ¼ 10
4 cryptoglandular
and 6 IBD fistulas
(all recurrent
fistulas, no
70%
(Median FU
230.5 days;
range 156–
523 days)
Slight anal
discomfort and
soiling (n ¼ 3); no
postoperative
incontinence
None
anorecto-vaginal
fistulas)
Gautier
et al. 2015
Prosst and
Joos 2016
n ¼ 17
11 cryptoglandular,
6 IBD, 1 urethra-
rectal fistula, and
7 rectovaginal
fistulas
n ¼ 100
89 cryptoglandular,
11 IBD, 5 anorecto-
vaginal, and
27 recurrent fistulas
18%
(Median FU
4 months;
–
range 2
7 months)
65%
(FU 6 months)
65% postoperative
pain
Well tolerable
postoperative pain;
late clip removal due
to pain, slight
discomfort, clip
76% primary
technical
failure, 65%
clip migration,
53%
abscesses
None
dislocation, secretion,
and wound-healing
problems (n ¼ 6)
Seow-En
et al. 2016
n ¼ 6
Cryptoglanduar
(5 recurrent
fistulas)
100%
(VAAFT
+OTSC)
(Median FU
No substantial
change in anal
control
None
34 months,
range 12–
44 months)
Dango
et al. 2017
n ¼ 22
Cryptoglandular
(no IBD,
1 recurrent and
1 anorecto-vaginal
fistula)
59%
(Median FU
36 months,
range 19–
48 months)
No incontinence, no
significant pain
(VAS4), no
necrosis/abscess/
ulcer, no foreign
body reaction
None
(continued)
27 Treatment by Over-the-Scope-Clip 443
Table 1 (continued)
Authors
and year of
publication
NordholmCarstensen
et al. 2017
Marinello
et al. 2018
Mascagni
et al. 2019
Tong et al.
2019
Grossberg
et al. 2020
Number of
operations and
types of fistulas
treated
n ¼ 35
32 cryptoglandular,
3 IBD, and
6 recurrent fistulas
n ¼ 10
9 cryptoglandular,
1 IBD and
8 recurrent fistulas
n ¼ 15
Cryptoglandular
(no IBD, no
recurrent fistulas)
n ¼ 16
Rectovaginal
fistulas (3 IBD and
13 recurrent
fistulas)
n ¼ 19
Cryptoglandular
(no IBD fistulas,
also recurrent
fistulas)
Healing rate
(follow-up)
49%
(Median FU
17 months,
range 13–
28 months)
60%
(Median FU
15 months,
range 6–
26 months)
93.3%
(3 years)
43.7%
(Median FU
10.2 months;
range 8–
36 months)
47%
(Median FU
145 days;
range 63–
298 days)
Postoperative
findings (e.g., pain,
incontinence, soiling)
Clip removal due to
discomfort (n ¼ 3)
and dyspareunia/
neuralgiform pain
(n ¼ 2); no
incontinence
Early clip removal
due to pain (n ¼ 1);
no fecal incontinence
Early clip removal
due to pain (n ¼ 1),
no incontinence
Early clip removal
due to pain and
abscess (n ¼ 1);
chronic pain and
ulceration (n ¼ 3); no
postoperative
incontinence
Unknown Unknown
Major
complications
None
None
None
None
the clip was well tolerated without complaints. After OTSC removal, anal discomfort or soiling completely disappeared. There was no postoperative incontinence.
Another German study published in 2017 reported on 22 patients with
cryptoglandular fistulas including one recurrent and one anorecto-vaginal fistula
treated with the clip (Dango et al. 2017). There were no intraoperative complications. After a long-term median follow-up of 36 months (range 19–48 months), the
authors observed a healing rate of 59%. In case of recurrence, the time to develop
symptoms was on average 6.9 months (range 3–11 months). The nine recurrences
included also the anorecto-vaginal fistula. There was no incontinence for flatulence
or stool after treatment. During follow-up no unexpected side effects or complications attributed to the clip such as significant pain (VAS 4), necrosis, abscess,
foreign body sensation or allergic reactions, or mucosal anorectal wall ulcer were
seen. No spont aneous detachment of the clip was observed. The clip was removed in
all patients on average after almost 5.8 months (range 3–12 months). Three patients
refused clip removal without complaining of any discomfort.
444 R. L. Prosst
In 2016, surgeons from Singapore published their experience with anal fistulas
operated by video-assisted anal fistula treatment (VAAFT) in combination with
another technique to close the internal fistula opening, such as anorectal advancement flap, stapler, or OTSC Proctology (Seow-En et al. 2016). VAAFT is an
endoscopic technique in which the fistula can be visualized and coagulated from
the inside by a rigid fistuloscope to achieve destruction and closure of the fistula
tract. The authors performed surgery in 41 patients with cryptoglandular fistulas
including 11 recurrent fistulas. The best results were achieved when VAAFT was
combined with OTSC (100%). Inferior healing results were seen when the internal
fistula opening was closed with staplers (78%) or advancement flaps (25%) following VAAFT. OTSC was found to enable a better sealing of larger and more fibrotic
internal fistula orifices.
Surgeons from Denmark treated 35 patients with 32 cryptoglandular, 3 Crohn‘s
disease associated, and 6 recurrent fistulas with OTSC Proctology (NordholmCarstensen et al. 2017). The median operative time was 41 min (range
34–49 min). There were no intraoperative complications. After a median followup of 17 months (range 13–28 months), the healing rate was 49%. The success rate
for cryptoglandular fistulas was 50% and for Crohn’s fistulas 33%. When the clip
was used as first-line therapy, the healing rate was 55% in contrast to 17% in
recurrent fistulas. The median time to failure was 28 days (range 15–65 days). The
clip was spontaneously lost between clinical controls in 4 patients (11%). The clip
was removed from 21 patients, most commonly because of a persistent fistula
(16/21). In three patients, subjective discomfort related to defecation and anal
hygiene caused by the clip on a low-lying internal fistula opening within the anal
canal necessitated clip removal. In another two patients, dyspareunia and
neuralgiform pain were the causes of clip removal. All of the symptoms unrelated
to fistula persistence disappeared after the clip was removed, and no permanent
adverse effects were encountered. All patients were fully continent both before and
after the procedure, regardless of whether fistula closure was successfully achieved.
In 2018, surgeons from Spain published their data on the treatment of 10 patients
with 9 cryptoglandular and 1 IBD-associated fistulas of which 8 were recurrent
fistulas (Marinello et al. 2018). The surgery was uneventful with a median operative
time of 28 min (range 20–50 min). One patient needed clip removal 1 week after
insertion due to anal pain. After a median follow-up of 15 months (range
6–26 months), the overall healing rate was 60%. Healing was achieved in 5 out of
9 cryptoglandular fistulas (56%) and in the IBD-associated fi
stula. Fifty percent of
the recurrent fistulas and all of the previously untreated fistulas were closed successfully. Two patients developed suppuration relapse within the first month after
surgery; however, they had more than 5 previous other fistula surgeries. One patient
showed a late recurrence 7 months after clip placement. No fecal incontinence was
noticed after the surgical procedure.
Surgeons from Italy (Mascagni et al. 2019) compared first-line cryptoglandular
fistula treatment with OTSC Proctology and fistulectomy with primary sphincter
reconstruction in a total of 30 patients. Both techniques rendered excellent long- term
results after 3 years (fistula healing 93.3% versus 100%). No patients reported to
27 Treatment by Over-the-Scope-Clip 445
suffer from pain after defecation and from gas or fecal incontinence. Although one
patient in the OTSC group needed clip removal due to pain on the 7th postoperative
day, the clip procedure was characterized by a reduced number of hospitalization
days (1.3 vs. 3.6 days) and less pain medications after treatment in comparison to
fistulectomy with sphincter reconstruction.
In 2019, surgeons from France evaluated the feasibility, safety, and effectiveness
of the clip for rectovaginal fistula repair in 16 patients (Tong et al. 2019). The most
common causes of rectovaginal fistula were adverse events following proctectomy
or pelvic radiotherapy, obstetric trauma, and inflammatory bowel disease. Thirteen
participants had undergone at least two previous surgical interventions before the
clipping procedure. Successful primary healing of the fistula was observed in seven
(43.7%) patients. There were no differences if the clip was placed as first surgical
intervention or following multiple attempts or regarding the etiology of the fistula or
with or without the presence of a stoma. Short-term complications were rare and
included pain and spontaneous clip detachment. Most recurrences appeared shortly
after the procedure, with a median delay of 45 days.
A recent publication from South Africa confirmed the results of previous studies
(Grossberg et al. 2020): a retrospective record review found 19 cases of
cryptoglandular fistulas treated with the clip. After a median follow-up of
145 days (range 63–298 days), nine procedures were successful (47%). Success
rates were higher for simple (66.7%) as opposed to complex (38.5%) fistulas. For
patients who underwent placement of the clip as a primary procedure, the success
rate (50%) was slightly better than those who received the clip as a secondary
procedure (44.4%).
A healing rate of only 18% noted in a French retrospective study on 17 patients
considerably stands out from all previous clinical reports on the clip procedure
(Gautier et al. 2015). The authors placed the clip in seven anorecto-vaginal fistulas
and one urethra-rectal fistula ( 47%, 8/17). Six patients had Crohn’sdisease(35%),
and another two patients had previous pelvic radiotherapy (12%). The authors
confirm that these underlying diseases had a significant negative selection bias in
their study. In addition, the authors admit to have had only v ery limited experience
with OTSC Proctology. Probably, these facts finally led to numerous postoperative complications, such as early clip detachment in 65%, primary technical
failure with persistent d ischarge after surgery in 76%, postoperative pain in
65%, and abscesses in 53%.
6 The Over-The-Scope-Clip (OTSC Proctology): Discussion
and Conclusions
Anorectal fistula surgery has to meet two essential requirements: first, eliminating
the fistula tract which causes secretion and hygienic problems leading to impaired
quality of life and work incapacity and, second, preserving the sphincter by a
minimally invasive surgical technique without extended wounds or major tissue
trauma to avoid fecal incontinence.
446 R. L. Prosst
For low uncomplicated fistulas not involving relevant portions of the sphincter
muscle, fistulotomy and fistulectomy will remain the gold standard. There is no
rationale for using modern fistulas techniques. For complicated, high transsphincteric, suprasphincteric, or extrasphincteric fistulas, modern fistulas techniques,
such as OTSC Proctology, compete with advancement flaps or with fistulectomy/
fistulotomy with primary sphincter reconstruction.
There are mainly two different ideas and principles on how to treat complex
anorectal fistulas which cannot be operated by simple fistulectomy or fistulotomy.
Video-assisted anal fistula treatment (VAAFT) (Meinero et al. 2014), Fistula Laser
Closure (FiLaC) (Wilhelm et al. 2017), and ligation of intersphincteric fistula tract
(LIFT) (Emile et al. 2020) intend to close or interrupt the fistula tract itself. Clip
surgery (OTSC Proctology) closes the internal fistula opening with its elastic Nitinol
clip while leaving the external orifice open for better drainage of the remaining tract.
In this regard, clip surgery is similar to the advancement flap treatment of fistulas: the
clip and the flap seal the internal fistula opening allowing to heal the fistula by
preventing inflowing stool and bacteria. As a consequence, the fistula tract, more or
less, dries out and closes.
One major drawback of standard procedures, such as fistulectomy with primary
sphincter reconstruction or advancement flap surgery, is the substantial change of the
mucosal surface, as well as the anatomical structure and symmetry. This leads to a
significant rate of stool incontinence and soiling in the long-term, even if surgery
succeeds in eliminating the fistula. The notable advantage of new techniques, such as
the clip or laser procedure, is their ability of being applied several times until fistula
closure occurs (Adegbola et al. 2017). In addition, they do not fundamentally alter
the anorectal anatomy, as the surgical effect is only around the course of the fistula
tract. Hence, the risk of postoperative incontinence is negligible.
OTSC Proctology is characterized by its intuitive design and stapler-like handling, so that it can be used by every surgeon after a brief explanation of the
procedure. As the clip is made of Nitinol, which is a biocompatible alloy, the clip
could stay in place even after fistula healing. The experience gained with the device
showed that the sharp-edged metal clip does not cause relevant pain or trauma in the
narrow anorectum. There are two ways how to deal with the implanted clip after
fistula healing. Some surgeons remove the clip as they fear that the remaining clip
could impair the anal sphincter and continence in the long run. But, clip removal
requires additional surgery and bears the risk of tissue trauma or even reopening the
fistula. Therefore, most surgeons leave the clip in place as long as it remains
asymptomatic. Only, if a patient experiences clip-related side effects, such as foreign
body sensation, pressure, or pain, clip removal may be necessary to eliminate these
adverse symptoms.
The evaluation of the existing studies about OTSC Proctology indicates that the
clip procedure is feasible, safe, and effective for the minimally invasive treatment of
anorectal fistulas. Best results can be achieved when the technique is applied in
cryptoglandular fistulas as first-line therapy. The use of the clip for recurrent fistulas
obviously renders inferior results. This might be attributed to increased scar tissue
around the internal fistula opening due to previous surgery impeding the secure hold