radical Trachelectomy

1. Laparoscopic Vaginal Radical Trachelectomy
A Treatment to Preserve the Fertility of Cervical Carcinoma Patients
Daniel Dargent, M.D.
Xavier Martin, M.D.
Amaloa Sacchetoni, M.D.
Patrice Mathevet, M.D.
Department of Gynecology, Hopital E. Herriot,
place d’Arsonval, 69437 Lyon Cedex, France.
Presented in part at the 25th Annual Meeting of the
Society of Gynecologic Oncologists, Orlando, Flor-
ida, February 6–9, 1994.
Address for reprints: Daniel Dargent, M.D., Depart-
ment of Gynecology, Hopital E. Herriot, place
d’Arsonval, 69437 Lyon Cedex 03, France.
Received April 12, 1999; revision received August
23, 1999; accepted September 2, 1999.
BACKGROUND. Cervical carcinoma occurs frequently in young women who would
like to preserve their childbearing potential. For those with early stage invasive
lesions, the authors designed and performed radical trachelectomy, a surgical
procedure that preserves the functions of the uterus.
METHODS. Radical trachelectomy combines laparoscopic (for pelvic lymphadenec-
tomy) and transvaginal approaches. Between April 1987 and December 1996, 56
patients were scheduled for this procedure, and 47 underwent it. The charts of
these patients were retrospectively reviewed for medical and obstetric history,
characteristics and complications of surgical procedures, pathologic findings, post-
operative obstetric results, and cancer recurrences.
RESULTS. The mean durations of the laparoscopic and vaginal steps of the proce-
dure were 62 and 67 minutes, respectively. One intraoperative complication (cys-
totomy) and seven postoperative complications (drainage of pelvic collection)
were observed. The pathologic tumor classification was International Union
Against Cancer (UICC) pT1a1 (International Federation of Gynecology and Obstet-
rics [FIGO] Stage pIA1) in 5 cases, UICC pT1a2 (FIGO Stage pIA2) in 13 cases, UICC
pT1b (FIGO Stage pIB) in 25 cases, UICC pT2a (FIGO Stage pIA2) in 1 case, and
UICC pT2b (FIGO pIIB) in 3 cases. The mean follow-up was 52 months. Two
recurrences (4%) were observed (one lateropelvic and one distant), and one patient
died of disease progression. Despite a 25% rate of late miscarriages, 13 normal
children were born after radical trachelectomy.
CONCLUSIONS. In young patients affected by early invasive cervical carcinoma,
radical trachelectomy does not appear to increase the rate of recurrence. It carries
a relative risk of infertility and late miscarriage but makes it possible for some
patients to become pregnant and give birth to normal newborns. Thus, it seems
reasonable to offer this procedure in selected cases, provided that each patient is
fully informed and the surgeon properly trained. Cancer 2000;88:1877–82.
© 2000 American Cancer Society.
KEYWORDS: radical trachelectomy, childbearing, laparoscopic vaginal radical tra-
chelectomy (LVRT).
Radical trachelectomy is a surgical procedure used to treat cervical
carcinoma that is considered a so-called less radical or conserva-
tive surgery: a radical procedure preserving the morphology and
functions of the involved organ. There is no area of study in which
conservative surgery makes more sense than cervical carcinoma: con-
servative surgery enables young women to preserve their childbearing
potential.
The Romanian gynecologist Aburel was the first to propose a
conservative approach in the surgical management of cervical carci-
noma while realizing the “subfundic radical hysterectomy”. His fol-
lower Sirbu1
did the same. They operated using the laparotomic
1877
© 2000 American Cancer Society

2. route. Their patients did not succeed in becoming
pregnant. The technique was given up.
Since 1987, we have performed a procedure that
combines laparoscopic and transvaginal approaches:
the laparoscopic vaginal radical trachelectomy
(LVRT). In our opinion, the requirements for this type
of treatment are as follows: young patients (younger
than 40 years old) who wish to preserve their fertility
who have early cervical carcinoma (T1a lesions with
risk of pelvic or parametrial lymph node involvement,
or T1b1–T2a lesions of small volume) protruding from
the exocervix. We presented this procedure for the first
time in 1994,2,3
and it was adopted by European and
American teams whose preliminary results were pub-
lished recently.4–7
We present here the results of our
experience from 1987 to 1997. We attempt to answer
two basic questions concerning a so-called limited
procedure: does the limitation of radicality lessen the
rate of survival, and, second, does it actually preserve
the morphology and the normal biologic functions?
METHODS
Technique
Laparoscopic lymphadenectomy is the prelude to the
vaginal radical trachelectomy (VRT). As a matter of
fact, VRT has to be reserved for early cases without risk
factors (see below). Lymphnodal involvement is the
most significant risk factor. The pN1 patients must be
excluded. Laparoscopic lymphadenectomy enables us
to evaluate the criteria for this exclusion.
For the laparoscopic pelvic dissection, we favor
the preperitoneal approach. The preperitoneal space
can be reached through either a suprapubic midline
incision2
or an infraumbilical one. The development
of the space can be performed by a digital preparation
or by direct optical separation thanks to the new tro-
cars that have a transparent tip and can cut at the
same time. Once the space has been developed and
insufflated with CO2, the pelvic dissection is per-
formed the same way as in the transumbilical trans-
peritoneal laparoscopy. The final objective is to re-
move entirely the lymph node-bearing tissues located
on both surfaces of the bifurcation of the common
iliac vessels.
Vaginal radical trachelectomy is a modification of
the Schauta Stoeckel procedure. The procedure has
been described elsewhere.3
It includes making a “vag-
inal cuff,” opening the ventrolateral dry spaces (vesi-
covaginal space and paravesical spaces), and then di-
viding the bladder pillars (vesicouterine ligaments) to
identify the ureters and uterine arteries. After opening
the Douglas pouch, the rectum pillars (rectouterine
ligaments) are divided. At this time, the paracervical
ligaments, the ventral and dorsal aspects of which are
visible, can be divided between two clamps, the most
lateral being placed 2 cm outside the vaginal cuff. The
last step of the procedure involves dividing the uterus
that is transected 5 mm underneath the isthmus. The
reconstruction includes closing the Douglas pouch,
putting a cerclage around the isthmus and reanasto-
mosing the vagina to the isthmus. No drain is left in
place. A Foley catheter is inserted for 2–6 days.
The decision to perform the laparoscopic vaginal
procedure can be made in one of two ways. With the
first option, the removed lymph nodes are assessed at
frozen sections, and the decision of whether to oper-
ate is made immediately. With the second option, one
awaits the results of the assessment of the embedded
nodes before deciding whether or not to go ahead with
the VRT.
The VRT specimen is assessed by frozen sections
just after it has been delivered. The patient is informed
that removal of the whole uterus may be necessary if
the upper margin of the specimen is involved. The
patient also is informed that the same option may be
necessary after the assessment of the embedded spec-
imen. This assessment is performed using the tech-
nique of semiserial giant sections.
MATERIALS AND METHODS
Between April 1987 and December 1996, 56 patients
were scheduled for LVRT. We obtained the patients’
informed consent before treatment. Eight patients
were excluded because of the results of the frozen
sections: true metastasis on one (or more) pelvic node
in four cases and involvement of the upper margin of
the VRT specimen in the other four cases. For one
patient, a total hysterectomy was decided upon after
the assessment of the embedded specimen (figures of
capillary-like space involvement [CLSI] spreading ex-
tensively in the tumor itself, in the paracervical liga-
ments, in the vaginal cuff, and in the pelvic lymph
nodes).
Patient demographics are shown in Table 1.
Among the 47 patients submitted to LVRT, 6 had been
treated for infertility including 3 for whom in vitro
fertilization has been attempted without success. In
contrast, five patients were pregnant at the time the
LVRT was scheduled (the pregnancies were undetec-
ted in two cases at the time of procedure). The histo-
type distribution of the tumors is a common one: 39
squamous carcinomas, 3 adenocarcinomas, 4 adeno-
squamous carcinomas, and 1 neuroendocrine carci-
noma.
The pelvic lymphadenectomy was not performed
in one case (large infiltrative lesion with only multiple
pinpoint invasions). In one other case the lymphade-
nectomy was performed through laparotomy (T1b1
1878 CANCER April 15, 2000 / Volume 88 / Number 8

3. carcinoma detected during the pregnancy: pelvic
lymphadenectomy at the time of the cesarean section
followed by VRT 8 weeks later). In the 45 remaining
cases, the lymphadenectomy was performed with the
laparoscope: preperitoneal approach in 40 cases and
transperitoneal approach in 5 cases, a one-stage pro-
cedure in 34 cases (frozen sections onto the removed
nodes) and a two-stage procedure in 11 cases.
Each patient’ progress was reviewed at the end of
June 1997. The median follow-up was 52 months (7–
123 months).
RESULTS
The laparoscopic pre-VRT lymphadenectomy lasted
an average of 62.0 minutes (Ϯ21.3). A conversion to
laparotomy was needed in 1 case (cystotomy). A post-
operative complication attributable to the laparo-
scopic lymphadenectomy led to a reoperation in five
cases (10.9%): control of a bleeding at Day 0 (one
laparotomy); opening of a hematoma between Day 5
and Day 19 (two laparotomies and two laparoscopies);
opening of a lymphocyst at Day 75 (one laparoscopy).
The mean time to perform VRT was 67.1 minutes
(Ϯ15.8). No complication leading to laparotomy was
observed during the procedure. The mean hemoglo-
bin gasp was 25.4 g/L. Blood transfusions were given
to three patients (6.4%) during the postoperative stay.
The average hospital stay was 7.0 days. (In France,
there is no shortage of hospital beds, and patients
tend to stay longer than in other countries.) An addi-
tional procedure was necessary in three cases (6.4%): a
postoperative colpotomy was performed in one case
at Day 8 (parauterine hematoma), and stenosis of the
cervix uteri was treated successfully by dilation in two
patients. Urinary retention and/or postmiction of 100
mL or more was observed at the time of catheter
removal (Day 0 to Day 6; median, Day 4) in 20 cases
(42.5%). At the 6-month review, one of the 20 patients
had persistent voiding difficulty.
After assessment of the embedded specimens
(lymph nodes and VRT), the tumor appeared to belong
to the International Union Against Cancer (UICC)
Stage pT1A (International Federation of Gynecology
and Obstetrics [FIGO] Stage pIA) in 18 cases: 5 UICC
Stage pTIA1 (FIGO Stage PIA1) and 13 UICC pTIA2
(FIGO Stage pIA2). Figures of lymphovascular spaces
involvement were present in three of the cases that
belonged to FIGO Stage pIA1 changing these cases to
the SGO Stage pIA2.
Among the 24 cases higher than UICC Stage
pTA1(FIGO Stage pIA), the tumor growth was limited
to the cervix in 19 cases. An extrauterine spread was
found in five cases. In the first case, the tumor itself
was confined to the cervix, but a CLSI was found in the
capsule of one of the pelvic lymph nodes (UICC pT1b
pN1). In the four other cases, a juxtauterine spread
was present in one case. In three out of these four
cases, the juxtauterine spread was discontinuous: tu-
mor deposit in the vagina in one case (UICC pT2A),
tumor deposit in the paracervix in one case (UICC
pT2B), and true metastasis in a paracervical lymph
node in one case (UICC pT2B). In the fourth case, a
direct involvement of the vagina was combined with a
discontinuous involvement (CLSI) of the paracervix
and most of the pelvic lymph nodes (UICC pT2BpN1).
The tumor diameter assessed onto the VRT spec-
imen was, for the UICC pT1b and higher (29 cases),
less than 2 cm in 21 cases and greater than 2 cm in 7
cases . A correlation is likely to exist between the
tumor diameter and the risk of extrauterine spread: no
extrauterine spread for the 18 UICC pT1a cases versus
3 for the 22 tumors (larger than UICC pT1a) less than
2 cm in diameter (13.6%) and 2 for the 7 lesions 2 cm
or greater in diameter (28.6%). The differences be-
tween UICCpT1a cases and tumors less than 2 cm and
between UICC pT1a cases and lesions greater than 2
cm are statistically significant (P Ͻ 0.1 and P ϭ 0.02,
respectively). But the difference between the second
and the third subsets is not statistically significant. By
contrast, no correlation can be established between
the CLSI figures found in the tumor itself and the
chances of extrauterine spread (P value not signifi-
cant): 2 extra-uterine spread for the 13 tumors harbor-
ing figures of CLSI (15.4%) compared with 3 for the 34
that did not (9.1%).
An adjuvant therapy was offered to the 16 patients
affected by a risk factor (CLSI or extrauterine spread):
two of them chose to be treated (brachytherapy in one
case [isolated tumor deposit in the vagina] and radio-
therapy in one case [true metastatic micro lymph
node in the paracervix]). For the two patients submit-
ted to adjuvant radiotherapy, laparoscopic ovarian
TABLE 1
Characteristics of the Patients
Characteristics No. of patients (%)
Age (yrs)
20–29 19 (40)
30–39 23 (49)
40 and older 5 (11)
Total 47 (100)
No. of children
0 25 (52)
1 or 2 17 (37)
3 or more 5 (11)
Total 47 (100)
Laparoscopic Vaginal Radical Trachelectomy/Dargent et al. 1879

4. transposition and paraaortic lymph node dissection
were performed before radiotherapy.
Recurrences were observed in two patients (4.3%):
Case 1: 20-mm large adenocarcinoma in a 27-year-old
nulligravida, 10 uninvolved nodes after laparoscopic
lymphadenectomy - CLSI onto the embedded VRT
specimen - aortic recurrence at 21 months, - death at
27 months. Case 2: greater than 5-mm-deep squa-
mous carcinoma of 25 mm diameter in a 33-year-old
nulligravida - 5 uninvolved nodes after laparoscopic
lymphadenectomy - CLSI onto the embedded VRT
specimen - dorsal side wall recurrence at 93 months -
surgical excision ϩ intraoperative radiotherapy ϩ ex-
ternal radiotherapy - living with n.e.d at 123 months.
As shown in Table 2, the rate of recurrences is
higher in the nonsquamous histotype population: 1 of
8 (12.5%) compared with 1 of 39 (2.5%) (P value); in
the CLSI involvement subpopulation: 2 of 13 (15.4%)
compared with 0 of 34 (P ϭ 0.02); and in the greater
than 2-cm tumor diameter subpopulation: 2 of 7 cases
(28.6%) compared with 0 out of 40 (P Ͻ 0.001).
The reproductive outcome data are summarized
in Figure 1 . Reproductive outcomes can be assessed
starting from the observation of 44 patients (3 exclu-
sions: 1 patient dead of disease after 27 months, and 2
patients submitted postoperatively to radiotherapy).
Among these 44 patients, 1 suffered a premature ovar-
ian failure, 22 continued to use contraception, and 8
did not succeed in conceiving (5 of them had been
treated for sterility before LVRT). Twenty pregnancies
were observed in the 13 patients who were able to
conceive. Conversely, in 5 cases, LVRT was performed
during pregnancy, leading to a total of 25 observed
pregnancies. Among the 25 pregnancies, 9 occurred in
patients who underwent the procedure before the re-
construction stage was added to the VRT procedure.
When the outcomes of these 9 pregnancies are com-
pared with the outcomes of the 16 other pregnancies,
the results are 1 abortion compared with 2, 3 early
miscarriages compared with 1 (P ϭ 0.07), 3 late mis-
carriages compared with 2 (P value not significant),
and 2 deliveries compared with 11 (P ϭ 0.025). In the
first subset, abortions and miscarriages occurred with-
out intervention, and deliveries were obtained
through abdominal cesarean section. In the second
subset, abortion and early miscarriages occurred with-
out intervention, but 2 of the 3 late miscarriages re-
quired an intervention (vaginal cesarean section), and
10 of the 11 deliveries were obtained using abdominal
cesarean section at 36 weeks on average.
DISCUSSION
The data presented enable us to answer the questions
about LVRT: its curative value and its impact on re-
productive potential.
The 47 patients who were managed using LVRT
FIGURE 1. Reproductive outcomes are shown. LVRT: laparoscopic vaginal
radical trachelectomy; mis: miscarriage.
TABLE 2
Recurrences in Relation with Tumor Characteristics
No. of cases
Relapses
local Pelvic Distant Total
Histotype
Squamous 39 0 1 0 1
Other 8 0 0 1 1
CLSI
No 34 0 0 0 0
Yes 13 0 1 1 2
Tumor diameter
Ͻ 2 cm 40a
0 0 0 0
Ն 2 cm 7 0 1 1 2
a
pT1a (18 cases) and pT1b and higher (22 cases).
1880 CANCER April 15, 2000 / Volume 88 / Number 8

5. have a median follow-up of 52 months. Two recur-
rences occurred: one aortic recurrence at 21 months
after LVRT and one dorsal side wall recurrence at 93
months after LVRT. This rate of recurrence is in ac-
cordance with the norm8
taking into account the tu-
mor’ characteristics (Table 2). The absence of centro-
pelvic recurrence has to be highlighted.
Among the 16 patients who were not considered
previously to be infertile and who actually tried to
become pregnant, 13 succeeded. Among the 20 preg-
nancies achieved, 10 resulted in the birth of a normal
newborn. Conversely, in the five cases in which LVRT
was performed during pregnancy, the pregnancy also
resulted in the birth of a normal child in three in-
stances. The sterility rate (3 out of 16, 18.75%) and the
fetal losses, particularly the ones due to the late mis-
carriages (6 out of 25, 24%), are much higher than in
the overall population, but the results can be consid-
ered as acceptable taking into account the context in
which they were achieved : all the patients referred to
us were initially scheduled for radical hysterectomy
and/or radical radiotherapy. Moreover, with regard to
the late miscarriages, a prophylaxis could be obtained
using the procedure devised by Saling9
and recently
popularized by Hormel and Kunzel:10
surgical closure
of the cervix performed at 12 weeks of gestation.
If one accepts that LVRT is a cost-effective alter-
native to radical surgery, one can ask if it has to be
offered to all young patients affected by early infiltra-
tive cervical carcinoma. In this regard, two situations
have to be considered: UICC pT1a lesions and UICC
pT1b (or higher) tumors.
For UICC pT1a lesions, one can speculate whether
LVRT is an appropriate procedure. In UICC pT1a1
cases (less than 3 mm infiltration) with no CLSI, pelvic
lymphadenectomy is not useful, and VRT could ap-
pear excessive. However, exceptions do exist, and
LVRT can be recommended in some instances: pin-
point invasion on a surface greater than 7 mm wide,
invasion of less than 3 mm deep in a specimen in
which margins are not clear. An alternative could be to
perform a new and larger conization, but the effect on
fertility would be the same, and it would be less safe.
Concerning pT1A2 lesions, a consensus exists about
the necessity of pelvic lymphadenectomy. There is a
strong correlation between the risk of pelvic lymph
nodes involvement and the risk of paracervical in-
volvement.7
As a consequence, performing a pelvic
lymhadenectomy without removing the paracervical
tissues is not logical. Laparoscopic vaginal radical tra-
chelectomy appears to be the best choice.
For early T1b (T1b1) and higher, the risk of failure
is prevailing. Our rate is 2 among 29. Tumor diameter
is the most important risk factor: our two recurrences
were observed in cases in which tumor diameter was
greater than 2 cm. Capillary-like space involvement
appears as another risk factor: our two recurrences
also involved patients with CLSI. Adenocarcinoma is
likely to be a third risk factor: one case in our two
recurrences. Our results are in accordance with the
one observed by Delgado et al.12
But, in fact, a discus-
sion of risk factors is only speculative when one con-
siders the small size of our series. In our opinion, the
patient must be informed, but we do not automati-
cally deny LVRT if one of the above-mentioned risk
factors is present.
More important than the intrinsic factors are the
conditions in which the LVRT is performed. First, it is
of great importance to have a precise preoperative
workup including conization for all clinically asymp-
tomatic cases and magnetic resonance imaging for the
clinically symptomatic cases. The second condition is
that the surgeon must be trained in both laparoscopic
and transvaginal oncologic surgery (an alternative
could be bilateral retroperitoneal pelvic lymphade-
nectomy using small incisions for the surgeons who
have not mastered the technique of laparoscopic dis-
section). The third condition, possibly the most im-
portant, is that pathologists must give indisputable
data.
Finally, it seems acceptable to offer LVRT to young
patients affected by early invasive cervical carcinoma
on the condition that the patient is fully informed and
the surgeon is properly trained. Laparoscopic vaginal
radical trachelectomy does not increase the rate of
recurrence. It carries a relative risk of infertility, but it
makes it possible for some patients to actually become
pregnant and give birth to normal newborns.
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