Keywords dysplasia unit - dysplasia - Pap smear - HPV - colposcopy
Introduction
In Germany there are currently 168 gynecologic cancer centers that are certified by
the German Cancer Society (DKG) (as of March 2022) [1 ]. In Germany and German-speaking regions there are 36 certified dysplasia units and
191 certified dysplasia consultations (as of November 2020) [2 ].
The division into a dual certification system can be explained based on the different
requirement profiles: dysplasia consultations are tied to individuals, and in the
context of
certification they are subject to less extensive requirements. Certification is granted
based on documentation evaluated by the Working Group for Cervical Pathology and Colposcopy
e.V. (in
German: AG-CPC). Coordination, publication, and archiving of certifications is then
managed by OnkoZert, an independent institute responsible for the certification process.
Gynecologic
dysplasia units are tied to individuals and institutions. Compared to dysplasia consultations,
they are required to meet a higher standard of medical expertise, advanced training
and
education, and research. The certification is administered by OnkoZert in a three-year
cycle. It is based on the fulfillment of medical requirements and characteristics
described in the
questionnaires and KPI forms (KPI: key performance indicator), and is subject to an
on-site audit by medical specialists in which the structures and processes of the
dysplasia unit are
reviewed. In addition, annual KPIs must be submitted as specific, quantifiable elements
for assessing the quality of results. These KPIs include inter alia attendance of
an interdisciplinary
tumor conference, indication for surgery in cases of CIN II+, and information on postoperative
resection status. These benchmarks are then published in the individual and combined
annual
reports [3 ].
The consented care algorithm of the interdisciplinary care chain for cervical cancer
patients is illustrated in [Fig. 1 ]
[4 ]
[5 ]. If any abnormalities are detected in gynecology examinations, the patient is referred
to a dysplasia unit or dysplasia consultation for further diagnostics. This unit is
affiliated to a gynecologic cancer center (in German: GKZ) certified by the DKG. Dysplasia
units may be linked to additional dysplasia consultations. In the diagnostic process,
the
interdisciplinary tumor meeting serves as a central decision-making body for all carcinomata,
as well as for difficult or rare cases of dysplasia. The GKZ collaborates closely
with its
interdisciplinary cooperation partners. The pathways for patients with malignancies
and dysplasia are set out in [Fig. 2 ].
Fig. 1 Approved algorithm for patients with cervical cancer [4 ].
Fig. 2 Procedures at the Gynecologic Cancer Center of Franconia for collaboration with the
dysplasia consultations/dysplasia units and additional cooperation partners; pathways
for patients with
malignancies and dysplasia.
These structural elements provide a basis for investigating abnormal findings detected
in the context of opportunistic cervical screening, and for switch to an organized,
HPV-based cervical
cancer screening program.
Scientific investigations of the dysplasia unit have been published on individual
prognosis factors such as tumor budding in the development of squamous epithelial
cervical carcinoma, HPV
integration and subtyping, the consistency of external vs. in-house cytologic results,
of colposcopic or vulvoscopic impressions and histology performed, and the accuracy
of biopsies of the
cervix, vulva and vagina performed by colposcopy [6 ]
[7 ]
[8 ]
[9 ]
[10 ]
[11 ]
[12 ]. This research has been presented at various scientific conferences.
For clinical, professional, and scientific reasons, the director of the dysplasia
unit is distinguished as an AG-CPC trainer and member of the Vulva Vagina Committee
of the Working Group for
Gynecologic Oncology (AGO). Colposcopy training courses with examinations leading
to the colposcopy diploma are offered annually (basic and advanced courses according
to the curriculum of the
AG-CPC). External observation placements in this area are also regularly offered.
In addition, a clinical colposcopic cytology and histology conference is held quarterly,
via the Comprehensive
Cancer Center Erlangen/European Metropolitan Region Nuremberg (CCC ER-EMN), as a forum
to discuss cases from the dysplasia unit and the GKZ involving clinical examination,
cytology, histology
and pathology of biopsies, and/or surgery using digital cytology and pathology. A
quarterly quality circle also takes place. All treating physicians are members of
the AG-CPC, and have
obtained the colposcopy diploma.
In this article we present a retrospective analysis of the structures of the dysplasia
unit in the Women’s Hospital of the University Hospital Erlangen, the first unit to
be certified in
Germany, prior to the introduction of the cervical cancer screening program which
has been in place since 1 January 2020 [13 ]. The certified dysplasia unit and colposcopy consultation represents a central point
of contact for patients with cytology abnormalities, persistent HPV infection, and
a
large variety of other genital diseases. The aim of this article is to present the
standardized procedures that have been established in our certified dysplasia unit.
Methods
The dysplasia consultation at the Women’s Hospital of the University Hospital Erlangen
was first certified in May 2014 (Dys-E001) as a dysplasia unit in cooperation with
the University
Gynecologic Cancer Center of Franconia. Certification was administered in accordance
with the criteria of the DKG, the German Society for Gynecology and Obstetrics e.V.
(DGGG), the working
group for gynecologic oncology (AGO), and the AG-CPC.
The cytology results are evaluated according to Munich Nomenclature III [14 ]
[15 ]. Following the conversion from Munich Nomenclature II to the new Munich Nomenclature
III which took effect on 1 July 2014, 2351 cytology smears were not included in this
evaluation, because they were taken during the transition phase and could not be adequately
converted into the new Munich Nomenclature III.
Patient Cohort
During the period from 1 July 2014 to 31 December 2019, 5594 patients attended 9772
appointments in our dysplasia unit. The subcohorts are not congruent because the diagnostics
(cytology,
colposcopy, HPV and histology) performed at each individual presentation were not
identical for all patients. The same applies for the surgeries included in our analysis,
as only a subsection
of the total cohort underwent surgery depending on the indication.
Due to spatial and structural overlaps with the GKZ in patients with urgently suspected
or confirmed carcinoma of the cervix, vagina, or vulva, these patients were excluded
from the surgical
cohort based on the objective of this study to present solely the dysplasia unit.
Moreover, the histologic, cytologic, and colposcopic findings only represent a portion
of the invasive cancers
since externally confirmed diagnoses were captured via the GKZ, and not via the dysplasia
unit.
Structured Processes
All patients with abnormal Pap smears are primarily examined in the dysplasia unit.
Consultation hours are held twice a week. There is a capacity for 20 to 30 patients
per consultation. In
addition, we have cooperation agreements with practices of three gynaecologists offering
dysplasia consultations (as of 2019). In case of abnormalities in the routine examination
by
gynecologists in private practice, the patient is referred to a certified gynecologic
dysplasia consultation or dysplasia unit for further diagnostics and appropriate treatment
[16 ].
The main reasons for referral are abnormal Pap smears detected through the statutory
cancer screening program, suspicious lesions, treatment-resistant complaints, or incidental
findings
detected in other special consultations at the Department of Gynecology and Obstetrics.
Management of appointments
During the consultation, and depending on the findings, a central appointment management
system ensures that appointments are scheduled in a timely manner. The OnkoZert requirements,
as
well as the requirements of the cervical cancer screening program set out in the guideline
on implementation of the organized cancer screening program (oKFE-RL), are listed
in [Table 1 ]
[17 ]
[18 ]. Appointments are managed based on the probability of a patient having dysplasia
or carcinoma. The OnkoZert requirements regarding appointment management were met.
Table 1
Comparison of requirements regarding appointment management in dysplasia units.
Cytology finding
OnkoZert requirements (as of July 2020) [17 ]
In-house standard (up until 31 December 2019)
oKFE-RL (valid from 1 January 2020) [16 ]
Abbreviations: HPV = human papillomavirus; oKFE-RL = Federal Joint Committee guideline
on organized cancer screening programs; UKF ER = Women’s Hospital at the University
Hospital
Erlangen
Cancer suspicion or group IVb
Colposcopy appointment < 4 weeks
Max. 2 weeks
Immediately
For cytology group IVa
Colposcopy appointment < 3 months
Max. 4 weeks
Immediately
If pregnant and for cytology group IVa or higher
Colposcopy appointment < 4 weeks
Max. 2–3 weeks
If pregnant and for cytology group IIID1 to up to the 12th week of pregnancy (WOP)
Colposcopy appointment up to the 20th week of pregnancy
Colposcopy appointment up to the 20th week of pregnancy
Medical consultation
Patients are asked to submit their previous findings in advance, or at the latest
at the time of their appointment. On the day of the examination, the patient is given
a medical history
form to fill in their general medical and gynecological history. In addition, as part
of the administrative procedure for admission to the outpatient clinic, the patient
is given the
“Information for patients with suspicious findings in the special outpatient clinic
for dysplasia and colposcopy – Certified Gynecologic Dysplasia Unit”. This leaflet
provides information on
how the examination is conducted, which behavioral measures are necessary after a
biopsy, and when and how the results will be communicated to them (supplementary online material:
Supplement 1 ). In a consultation a symptom-related medical history is taken regarding symptoms,
risk factors (e.g., nicotine, sexual behavior), HPV vaccination, desire to have children,
previous treatment, and secondary diagnoses of particular relevance (such as immunosuppressive
diseases or malignancies).
Clinical examination
Initially, the portio vaginalis uteri is adjusted appropriately using a transparent,
single-use speculum (available in four sizes). The area is then dabbed to remove mucus
or detritus, and
a native smear is taken, as well as a microbiology smear if applicable. After this,
separate Pap smears are taken from the portio vaginalis uteri and from the cervical
canal (with a swab or
cytobrush). Then the HPV smear is taken. Testing in the laboratory was originally
performed with the Hybrid Capture 2 High-Risk HPV DNA Test (Qiagen, Düsseldorf) which
does not differentiate
between HPV subtypes; this was switched to the Abbott RealTime High-Risk HPV Test
2000 (Abbott Laboratories, Chicago, USA) in September 2017. This test detects HPV
types 16, 18, 31, 33, 35,
39, 45, 51, 52, 56, 58, 59, 66, and 68.
This is followed by differential colposcopy with application of 5% acetic acid solution,
Lugol’s solution where applicable, green filtering where applicable in the case of
suspicious
findings (before and after acetic acid), (cervical) strip biopsy, and/or endocervical
curettage (ECC), and colposcopic assessment of the vaginal wall, vulva, and anus.
Photo or video
documentation is recorded using a binocular video colposcope (Zeiss Colposcope KSK
150 FC). A bimanual rectovaginal examination can then be performed as an option depending
on the clinical
findings. Upon desire, patients can watch the entire examination on a monitor and
have abnormalities explained to them. The medical history, examination, photo documentation,
and colposcopy
results (i.e., suspicion of CIN I–III) is saved as a paperless digital file, and is
also added to a database of findings (Microsoft Access). In addition, a sketch of
the examination results
is documented on paper.
Debriefing
The colposcopic impression of the examination is then discussed with the patient.
If surgery is indicated, the lesion and the procedure are explained to the patient
with reference to a
sketch of the genital region specifically generated by an anatomical draftsman (supplementary online material: Supplement 2 ). After receiving the findings (Pap, HPV, where applicable
microbiology smear, histology, etc.), the final diagnosis is made and treatment is
commenced as indicated by the specialist/senior physician. Standards for diagnosis
and therapy (“Standard
Operating Procedure”, SOP) exist for common findings, which, if available, are based
on the applicable guidelines (supplementary online material: Supplement 3 ). Finally, a doctor’s
report is sent to the patient and to their gynecologist/referring doctor in private
practice.
Interdisciplinary concept
Cases of carcinoma and suspicious findings in post-carcinoma patients detected in
the certified gynecological cancer center (in the case of malignancy or unusual disease
courses) are
presented at an interdisciplinary tumor conference. This involves a close collaboration
between all cooperation partners ([Fig. 2 ]). In the dermatological department, a separate interdisciplinary inflammation board
is held, in which multimodal therapy options are discussed, for example in the
case of dermatological autoimmune diseases.
Statistical Analysis
The cohorts (cytology, HPV, colposcopy, and histology) were constituted from the prospective
database of findings, and the type of surgery based on ICD codes and OPS codes for
the cervix,
vagina, or vulva from the Meierhofer MCC software (supplementary online material: Supplement 4 ) [19 ]
[20 ]
[21 ]
[22 ]. The exact cohorts were compiled using Microsoft Access 2016 and an SQL (Structured
Query Language) script. Descriptive analyses were performed in IBM SPSS Statistics
on
the distributions and frequencies.
Results
In total, 99.48% of all patients with abnormal Pap smears presenting at the Department
of Gynecology and Obstetrics, Erlangen University Hospital, were initially examined
in the dysplasia
unit.
Diagnostic results
A total of 16061 colposcopic, vulvoscopic, and/or anoscopic examinations were documented.
Cytology testing (in accordance with Munich III) was performed in 12197 patients,
HPV testing in
8193 patients, and a biopsy was taken in 4850 patients.
Cytology/HPV
The results of the cytology examinations (n = 12197) are listed in [Fig. 3 ]. In 51.2% of patients, the cytology findings were normal (group I). With regard
to abnormal cytology findings requiring further diagnostics to confirm dysplasia,
10.8% were in group IIID1, 5.6% in group IIID2, and 9.75% in group IVa-p. Group IVb-p/V
findings indicating suspected carcinoma were observed in 2.97% of all cases.
Fig. 3 Cytology results.
A total of 8193 HPV high-risk tests were documented; among these, 3454 cases (42.2%)
were positive and 4739 cases (57.8%) were negative.
Colposcopy
Results from colposcopy/vulvoscopy, and anoscopy obtained immediately after the examination
(n = 16061) are presented in [Fig. 4 ]. The 16061 examinations of the cervix and/or vulva and/or vagina and/or anus were
performed in 5593 patients at 9754 appointments. This computes to around 1.7
appointments per patient and 2.9 colposcopies per patient for the period analyzed.
Fig. 4 Colposcopy results. AIS = adenocarcinoma in situ; CIS = carcinoma in situ; dVIN =
differentiated vulvar intraepithelial neoplasia; VIN = vulvar intraepithelial neoplasia
Dysplasia-free colposcopic findings were obtained in 57.7%. These included benign
alterations with and without complaints such as treatment-resistant pruritus, recurring
colpitides,
postcoital bleeding, vulvodynia, chronic disease, congenital malformations, labial
hypertrophy, or women with different forms of female genital mutation (FMG).
For the CIN2+ group (CIN II, CIN III, CIS: carcinoma in situ, AIS: adenocarcinoma
in situ or cervical carcinoma), 2926 colposcopies showed a progression as a vulvar
dysplasia, with VIN2+
observed in 72 and VaIN2+ observed in 81 colposcopies. In 23 colposcopies, synchronous
or metachronous HSIL/carcinoma of the cervix, vagina, and vulva were observed in all
three
localizations.
The distributions of colposcopy results by localization showed that CIN III/HSIL was
the second most frequent cervix biopsy observed. In other localizations of the vulva,
vagina, and anus,
HSIL was not always the most common observation following dysplasia-free findings
([Fig. 5 ]
a–d ).
Fig. 5 Colposcopy results by localization. Cervix (a ), vulva (b ), vagina (c ) or anus (d ).
Histology
From a total of 4850 histologies, 27.8% did not involve dysplasia. Among mild, moderate,
and severe dysplasia cases, cervical dysplasia was the most frequent at 54.9% (n = 2663
cases),
followed by vaginal dysplasia at 6.5% (m = 316), just slightly ahead of vulvar dysplasia
at 6.3% (n = 310). HSIL of the vulva (n = 124) was more frequent than HSIL of the
vagina (n = 108);
LSIL of the vulva was biopsied less frequently because it is more easy to assess.
CIN I (LSIL) of the cervix was observed in 20.4% of cases (n = 989), and CIN II/CIN
III/CIS/AIS (HSIL) of
the cervix was observed in 34.5% of cases (n = 1674) ([Fig. 6 ]). The distribution of histology results showed that in cervical biopsies in particular,
CIN III/HSIL was observed more frequently than dysplasia-free findings. In the
other localizations of the vulva, vagina, and anus, dysplasia-free findings or LSIL
where the most frequent histological diagnoses ([Fig. 7 ]
a–d ). These dysplasia-free findings included inflammatory changes/hyperkeratosis without
other pathologies, scars, polyps, cysts or metaplasia.
Fig. 6 Histology results from the samples taken.
Fig. 7 Histology results from the samples taken according to localization. Cervix (a ), vulva (b ), vagina (c ) or anus (d ).
The most frequent histological diagnoses of benign conditions requiring treatment
were lichen sclerosus/lichen ruber planus/simplex, and genital warts.
Therapeutic procedures
A total of 2009 patients underwent surgical procedures; these comprised 1641 surgeries
on the cervix, 239 operations on the vulva, and 129 operations on the vagina. These
are listed in
[Fig. 8 ], [Fig. 9 ], and [Fig. 10 ]. Operations on the cervix, vulva, and vagina were divided into solely destructive
laser evaporization procedures, and excision procedures. The indication for laser
evaporization was determined based on histology, having previously excluded the possibility
of (micro)invasion through colposcopy or vulvoscopy.
Fig. 8 Types of surgeries for CIN I–III.
Fig. 9 Types of operation on the vulva.
Fig. 10 Types of operation on the vagina.
Contraindications for laser evaporization are confirmed AIS, TZ3 (transformation zone
3), age > 50, or a discrepancy between the colposcopy, cytology, and histology findings.
Laser
therapy is performed on areas showing abnormalities and on the cervical transformation
zone. LOOP excision with laser evaporization and cervical curettage is a hybrid procedure
involving
both destructive techniques and excision techniques. In this procedure, a representative
biopsy is taken from the punctum maximum of the HSIL using a small wire loop to remove
surface
material for additional histological confirmation of the lesion diagnosis. This is
followed by cone-shaped laser evaporation of the wound bed and transformation zone
in order to ensure a
clinical Ris0 situation, as well as maximum destruction of HPV-infected cells. After
every laser evaporization or conization procedure, cervical curettage is performed
in order to further
exclude the risk of endocervical dysplasia.
Key performance indicators
Within the scope of certification of a dysplasia unit, key performance indicators
must be fulfilled [3 ].
KPI 4 covers the preoperative performance of a colposcopy for diagnostic clarification
in the dysplasia unit following abnormal cytology results. The target is ≥ 95% ([Table 2 ]).
Table 2
Results for KPI 4 (Performance of a clarification colposcopy) for the period from
2015 to 2019 [20 ].
Year
2015
2016
2017
2018
2019
Rate
100%
98.80%
98.83%
99.57%
96.40%
KPI 5 relates to the resection rate of ≥ CIN2 lesions, which should be as high as
possible. The target is ≥ 85% ([Table 3 ]).
Table 3
Results for KPI 5 (excision with histology ≥ CIN II/HSIL) for the period from 2015
to 2019 [20 ].
Year
2015
2016
2017
2018
2019
Rate
90.94%
90.42%
92.13%
91.74%
88.74%
KPI 7 captures the proportion of R0 resections in surgeries performed on the cervix
due to CIN III/ HSIL, and the target value is ≥ 80% ([Table 4 ]).
Table 4
Results for KPI 7 (proportion of R0 resections in CIN III/HSIL) for the period from
2015 to 2019 [20 ].
Year
2015
2016
2017
2018
2019
Rate
91.76%
85.71%
88.48%
98.70%
96.61%
Discussion
In our certified dysplasia unit, a standardized process for special outpatient care
of genital dysplasia and diseases of the vulva and vagina has been established. This
is based on the S3
guideline on prevention of cervical cancer (Working Group for Scientific Medical Societies
(AWMF) registry number 015/027OL), the S3 guideline on diagnosis, therapy, and follow-up
of cervical
cancer (AWMF-Registernummer 032/033OL), the S2k guideline on diagnosis, therapy, and
follow-up care of vulvar cancer and its precursors (AWMF registry number 015/059,
and the S2k guideline on
diagnosis, therapy and follow-up of vaginal cancer and its precursors (AWMF registry
number 032/042) [21 ]
[22 ]
[23 ]
[24 ].
The established concept of the dysplasia unit presented in this study was analyzed
retrospectively. It provides a framework for the deployment of new screening strategies.
Due to the fact
that since 1 January 2020 low-risk groups (HPV high-risk positivity, group II-p, II-g,
IIID1) should undergo colposcopy, the amount of referred patients has increased. To
mitigate this,
according to a statement by the AG-CPC, this patient cohort should only receive an
early colposcopy if there is evidence of HPV type 16 or 18 [25 ]. Only time will tell the further development of screening algorithms for the prevention
of cervical carcinoma after the initial evaluation of the screening program.
The certification process outlined is increasingly being considered by patients. In
a multicenter study, 2500 patients were surveyed about their knowledge of certified
centers during a
13-month period. In total, 53.4 percent of all surveyed patients understood the concept
of a certified center, and 43.8% reported that this was their (main) motivation for
presenting to a
certified center [26 ].
Quality criteria
The quality criteria for certification of a dysplasia unit include specific KPIs,
with several of these exclusively applying to dysplasia units. These KPIs include
a target rate of ≥ 95%
for performing preoperative colposcopies in all patients with abnormal cytology findings
(KPI 4). The aim of a targeted colposcopy examination is to assess the maximum extent
of the lesion,
and thus to determine how it should be treated. This is consistent with results from
the TOMBOLA studies, which also showed that performing colposcopies for diagnostic
clarification can
avoid overtreatment and associated unnecessary costs, as well as physical and psychological
stress for patients [27 ]
[28 ]
[29 ]. Abnormal cytologic findings must be investigated preoperatively by colposcopy in
accordance to guidelines in order to locate the dysplasia. A solely abnormal Pap smear
without colposcopic examination is not an indication for surgery. Otherwise, if surgery
is performed directly without colposcopy, dysplasias in unsuspected locations (e.g.,
ectocervical,
vaginal, or vulvar dysplasia) may be missed, or unnecessary surgery may be performed
on a regressive lesion [14 ].
KPI 5 for dysplasia units comprises maintaining a high resection rate for ≥ CIN2 lesions.
Because of the possibility of spontaneous remission, CIN II/HSIL lesions should be
examined at
least every 24 months, depending on the age of the patient. In patients under 25 of
age, CIN II/HSIL lesions must be examined at least every 24 months, and CIN III/HSIL
lesions should be
examined at least every 12 months [21 ]
[22 ]. Due to their high regression rate of > 80%, surgery for CIN I/LSIL lesions should
not be indicated directly [21 ]
[22 ]
[30 ]. If persisting, an ablation procedure should be favored instead of excision, depending
on the transformation zone.
KPI 7 includes the proportion of R0 resections in CIN III/HSIL lesions with a target
of ≥ 80%. Surgeries are performed with colposcopic monitoring in order to reduce the
volume of
resection, and at the same to time to increase the rate of Ris0 situations through
targeted excision. In the case of laser evaporizations and LOOP excisions with laser
evaporization, the
extent of the in-sano region that needs to be removed with pathological CIN2+ lesions
should be discussed, as laser evaporation of the transformation zone after excision
should ensure a
clinical Ris0 situation or allow any potential residual HSIL to resolve through immunological
processes. In Ris1 situations without suspicion of invasive carcinoma, no immediate
reoperation
should be performed in accordance with the guidelines [21 ]
[22 ]. Moreover, if the dysplasia expands to the ectocervical region, a significant tissue
preservation can be achieved for the patient. Cervical curettage provides insight
into the endocervical safety margin, while in the ectocervical region, colposcopy
follow-up provides adequate certainty. In addition, the standardized co-testing follow-up
at 6, 12, and 24
months, as specified in the guidelines, is highly sensitive for detecting either persistence
or healing [21 ]
[22 ].
Often, a cytology smear is not repeated in dysplasia units or consultations. However,
it has been shown that only 47.65% of smears taken in the context of routine monitoring
correlate with
colposcopy-guided Pap smears performed in a dysplasia unit as part of the diagnostic
algorithm [8 ]. Therefore, a cytological smear and also an HPV-HR test in group I are taken again
at first presentation at the Dysplasia Unit of the Erlangen University Hospital. The
results in relation to colposcopy, cytological and histological results showed in
own published evaluations that the detection rate of dysplasia of the cervix differs
depending on the
setting (routine versus further clarification). Colposcopy-guided Pap smears correlate
significantly better to histology results than cytology smears taken in the context
of routine
screening without colposcopy guidance [8 ]. Colposcopy-guided biopsies also play an important role in the detection of vaginal
HSIL [10 ]. A combination of colposcopy findings, cytology, HPV PCR, and colposcopy-guided
biopsy is required in order to correctly diagnose HSIL [12 ]. For this reason these results, which have already been published, are not discussed
further in this article.
In general, type 1–3 excision is considered the gold standard [31 ]; however, the surgical procedure can be modified if the lesion is in an ectocervical
location and/or in younger patients who plan to have children. For example, in
younger patients planning to have children, laser evaporization with cervical curettage
or a LOOP excision with peripheral laser evaporization and cervical curettage may
be performed as the
sole treatment, even in the presence of severe cervical dysplasia (CIN III/HSIL).
However, this requires preoperative colposcopy to examine the transformation zone
(TZ 1/2) and smear tests
(Pap and HPV) in group ≤ IVa-p patients, as well as biopsy of the most conspicuous
lesion to rule out (micro)invasion.
Colposcopic assessment itself is subjective and depends on the expertise of the physician
performing the examination; for this reason, biopsies are indicated for diagnostic
clarification of
abnormal findings [12 ], and are consistent with the histology results from the operation in 71.9% of cases
[10 ]. In any case, colposcopy and colposcopy-guided biopsies are low-risk forms of examinations
whose rare side effects of pain, bleeding, anxiety or inflammation have been
published [32 ]. In the authors’ opinion, it is acceptable (including from a legal point of view)
to perform this procedure with verbal consent from the patient without obtaining
written consent, as it guarantees optimal diagnosis, thus enabling individualized
therapy in accordance with the guidelines.
In our dysplasia unit, surgeries are performed under colposcopic guidance. After intraoperative
application of Lugol’s iodine, the majority of dysplasias can be demarcated, with
the aid of
preoperative marking, in order to work on the entire transformation zone with HPV-infected
epithelial cells, reducing the volume of resected material, and defining the resection
margins more
precisely under colposcopic guidance.
In addition to solely dysplasia diagnostics, a special outpatient clinic is essential
for patients with chronic complaints. Especially for patients with lichen sclerosus,
lichen ruber
planus, or chronic vulvitis, the initial diagnosis is often preceded by a long period
of suffering. In patients with lichen sclerosus, it takes an average of five years
to obtain an initial
diagnosis. In these cases, interdisciplinary cooperation between the various specialties
involved can often lead to a faster diagnosis and better treatment for the patient.
In cases of
chronic vulvitis, severe forms of lichen sclerosus, or genital atrophy, fractional
CO2 laser therapy of the vulva and/or vagina can be offered as a treatment option. This
procedure creates needle-prick-like microwounds in the epidermis which lead to contraction
and regeneration of collagen fibers, angiogenesis, increased blood circulation, and
stimulation of
growth factors. These increase the elasticity of the skin [33 ]
[34 ]
[35 ]. However, there is currently no long-term follow-up data.
Conclusion
This retrospective analysis of our dysplasia unit provides a framework for the deployment
of new screening strategies. However, improvements to the existing structures are
essential,
particularly since patient numbers are expected to significantly increase following
the new decision of the Federal Joint Committee. There is also a need for discussing
the further procedure
after clarification colposcopy; this issue is not yet addressed in the current G-BA
algorithm for diagnostic clarification. The recommendation for (persistent) cytological
abnormalities or
persistent HPV positivity remains unclear and needs to be discussed.
