Transcript Laparoscopic Ablation For Minimal Or Mild Lesions In

Laparoscopic Ablation For Minimal
Or Mild Lesions In Endometriosis
Associated Subfertility
Hesham Al-Inany, M.D
[email protected]
Dr Al-Inany is a Senior Lecturer at Cairo
University and IVF specialist at the Egyptian IVFET Center. He has conducted the first prospective
meta-analysis in the entire filed of gynecology
comparing GnRH agonist vs antagonist in
assisted conception. Dr.Al-Inany is responsible
for "Evidence Based Medicine" corner in the
Middle East Fertility Society Journal for more
than 3 years, explaining the values of evidence
based medicine and it tools. He has published
over 25 scientific articles since he obtained his
medical qualification in Obstetrics & Gynecology
in 1998.
Definition
Endometriosis, defined as the
presence of endometrial glands and
stroma at ectopic sites, is still not yet
fully understood
Prevalence


Endometriosis prevalence varies widely being
seen more frequently among
women
investigated for infertility (21%) than among
those undergoing sterilisation (6%).
Among those being investigated for chronic
abdominal pain, the incidence of endometriosis
is 15%, while among those undergoing
abdominal hysterectomy, it can be as high as
25%.
relation of minimal or mild
endometriosis to subfertility is
not established. The association
is not necessarily cause and
effect.
 The
Hence, the concept that minimal or mild
endometriosis should always be treated to
avoid worsening of the condition is
controversial (Buyalos RP, Agarwal
SK,2000)

Minimal/mild
endometriosis
could
represent a temporary phase in an ongoing process that usually results in
cytolysis
of
recently
implanted
endometrial cells, whereas in a few
immunologically
'tolerant'
subjects,
nodular, cystic and infiltrating lesions
develop
Diagnosis
 The
gold standard test to diagnose
endometriosis
is
the
direct
visualisation of classical or subtle
lesions at laparoscopy.
Is it progressive!!!
 In
the medical literaturer, there is
one small randomised controlled
trial (RCT) in which repeat
laparoscopy was performed in the
women treated with placebo.
 Over
12 months, endometrial
deposits resolved spontaneously in a
quarter, deteriorated in nearly half,
and were unchanged in the
remainder. (Cooke,1989)
Where we stand?
 Whether
minimal endometriosis is a
condition that is frequently selflimited or resolves spontaneously or
not, we still face a problem. Could
ablation of minimal or mild
endometriosis be associated with an
increase in pregnancy rate. This is
the hypothesis to be tested.
Treatment modalities
 Conventional
treatments
for
endometriosis aim to remove or
decrease
deposits
of
ectopic
endometrium. They achieve this
either by inducing atrophy within
the hormonally dependent ectopic
endometrium, or by destroying the
endometriotic implant.
 Medical
treatment options for
endometriosis include hormonal
drugs such as the combined oral
contraceptive,
progestogens,
danazol,
gestrinone
or
gonadotrophin releasing hormone
analogues for pain relief.
 The
aim of therapy is to "switch off
ovarian function". Their role in
infertility
treatment has been
reviewed in a Cochrane systematic
review which concluded that there is
no evidence to support their use in
women with endometriosis who wish
to conceive. (Hughes,1999)
 While
these approaches continue to
be useful for the management of
endometriosis associated pain, they
may do more harm than good in
women whose major concern is
fertility. For the six months or more
of treatment, women are forced to
contracept.
 The
other option for women with
endometriosis who wish to conceive
is surgical ablation of deposits of
endometriosis. The surgery may be
performed
laparoscopically
including
excision,
laser
or
diathermy ablation and adhesiolysis.
Where is the evidence?
A
prospective cohort analysis was
conducted to analyze results from
579 women with endometriosis to
evaluate the role of surgery in the
treatment
of
endometriosis
associated with infertility. Adamson
GD, Pasta DJ ,1994)
 Interventions
consisted of no
treatment, medical treatment, or
surgical treatment by laparoscopy or
laparotomy. The main outcome
measure was pregnancy rates.
 For
minimal and mild disease, no
treatment,
laparoscopy,
and
laparotomy had equivalent 3-year
estimated
cumulative
life-table
pregnancy rates (67% +/- 12%, 68%
+/- 4%, and 74% +/- 8%,
respectively) that were higher than
medical treatment pregnancy rates
(p = 0.003).
The authors urged for
prospective randomized trials
to be performed to confirm
these findings.
RCTs
 Marcaux
et al, 1997 conducted a
randomized controlled trial to reach
a clear evidence on ablation of
minimal or mild endometriosis. They
studied 341 infertile women 20 to 39
years of age with minimal or mild
endometriosis.
 During
diagnostic laparoscopy the
women were randomly assigned to
undergo resection or ablation of
visible endometriosis or diagnostic
laparoscopy only. They
were
followed for 36 weeks after the
laparoscopy
 The
corresponding rates of fecundity
were 4.7 and 2.4 per 100 womanmonths (rate ratio, 1.9; 95%
confidence interval, 1.2-3.1).
 Fetal
losses occurred in 20.6% of all
the recognized pregnancies in the
laparoscopic-surgery group and in
21.6% of all those in the diagnosticlaparoscopy group (P=0.91). The
authors concluded that Laparoscopic
resection or ablation of minimal and
mild
endometriosis
enhances
fecundity in infertile women.
 Two
years later, a group from Italy
have conducted another randomized
controlled trial
to evaluate the
available evidence. Eligible women
were randomly assigned to resection
or ablation of visible endometriosis
(54
patients)
or
diagnostic
laparoscopy only (47 patients).
 Follow
up for one year showed
that
12 (24%) in the
resection/ablation group and 13
(29%) in the no treatment group
conceived; the difference was not
significant.
Comments
 Two
points should be noticed in
these two trials. First, in order to be
able to conclude that removing
endometriosis is effective, then it
would be better not to do the
adhesiolysis which can be considered
as a co-intervention. However, this
was not done.
 The
second point is that the patients
were informed about the result of
procedure done (ablation or no
ablation)
immediately
after
laparoscopy at their postoperative
appointments. This could have a
possible negative placebo effect on
those in expectant group or a
positive placebo effect in those who
had ablation.
 If
we consider only late pregnancies
in the these two trials (50/172 in the
ablation group versus 29/169 in the
no surgery group in the Canadian
study and 10/54 versus 10/47
respectively in the Italian study), the
O.R would be 1.64 (95% CI, 1.02–
2.67) noticing that the lower
confidence interval limit is too close
to unity
NNT
 If
we express the results more
practically in terms of number of
women to undergo surgery to
achieve an additional pregnancy. In
this case, even taking into account
only the results of the Canadian
trial, the benefit of laparoscopic
ablation appears less encouraging.
 The
net result is that eight
women with minimal to mild
endometriosis need to undergo
laparoscopic ablation to achieve
an additional late pregnancy.
 However,
considering that we cannot
identify women with endometriosis
preoperatively,
and
that
the
proportion
of
subjects
with
endometriosis in the Canadian series
of patients undergoing laparoscopy
for unexplained infertility was a little
<50%, the number needed to be
treated doubles at least
More Over
 Interestingly,
the Canadian group
has also conducted a well designed
prospective cohort study (1998) to
assess whether infertile women with
minimal or mild endometriosis have
lower fecundity than women with
unexplained infertility.
 Infertile
women with minimal or
mild endometriosis (n = 168) were
compared
with
women
with
unexplained infertility (n = 263).
Both
groups
were
managed
expectantly. The women were
followed up for 36 weeks after the
laparoscopy or, for those who
became pregnant, for up to 20 weeks
of the pregnancy.
 Fecundity
was 18.2% in infertile
women with minimal or mild
endometriosis and 23.7% in women
without
endometriosis.
The
fecundity rate was 2.52 per 100
person-months in women with
endometriosis and 3.48 per 100
person-months in women with
unexplained infertility.
 The
crude and adjusted fecundity
rate ratios were 0.72 and 0.83 (95%
confidence interval = 0.53-1.32),
respectively. Thus, The fecundity of
infertile women with minimal or
mild
endometriosis
is
not
significantly lower than that of
women with unexplained infertility.
 Many
investigators are wondering if
minimal or mild endometriosis is
really a disease that needs treatment.
Conclusion
 Laparoscopic
ablation for minimal
or mild endometriosis associated
subfertility seems to be of very
limited efficacy. Exposing those
women to unnecessary anaesthesia
and laparoscopic manipulations
should not be done except in the
context of randomized controlled
trial
Recommendations
(if you decide to do ablation)
 Exclude
all other causes of
subfertility
 Estimate
the probability of
pregancy with and without
treatment.
 Counsel the couple.
 Decide
on the most appropriate
ablation
modality
available
(laser, diathermy…)
 Assess the potential for harm
with this treatment (e.g.pelvic
adhesions)
 If ablation is still to be done,
ensure that it is
provided
optimally.