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Laparoscopic Ablation For Minimal Or Mild Lesions In Endometriosis Associated Subfertility

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He has published over 25 scientific articles since he obtained his medical ... For the six months or more of treatment, women are forced to contracept. ... – PowerPoint PPT presentation

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Title: Laparoscopic Ablation For Minimal Or Mild Lesions In Endometriosis Associated Subfertility


1
Laparoscopic Ablation For Minimal Or Mild Lesions
In Endometriosis Associated Subfertility
Hesham Al-Inany, M.D kaainih_at_link.net
2
Dr Al-Inany is a Senior Lecturer at Cairo
University and IVF specialist at the Egyptian
IVF-ET 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.
3
Definition
  • Endometriosis, defined as the presence of
    endometrial glands and stroma at ectopic sites,
    is still not yet fully understood

4
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.

5
  • The relation of minimal or mild endometriosis to
    subfertility is not established. The association
    is not necessarily cause and effect.

6
  • 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)

7
  • Minimal/mild endometriosis could represent a
    temporary phase in an on-going process that
    usually results in cytolysis of recently
    implanted endometrial cells, whereas in a few
    immunologically 'tolerant' subjects, nodular,
    cystic and infiltrating lesions develop

8
Diagnosis
  • The gold standard test to diagnose endometriosis
    is the direct visualisation of classical or
    subtle lesions at laparoscopy.

9
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.

10
  • Over 12 months, endometrial deposits resolved
    spontaneously in a quarter, deteriorated in
    nearly half, and were unchanged in the remainder.
    (Cooke,1989)

11
Where we stand?
  • Whether minimal endometriosis is a condition that
    is frequently self-limited 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.

12
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.

13
  • 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.

14
  • 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)

15
  • 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.

16
  • 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.

17
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)

18
  • Interventions consisted of no treatment, medical
    treatment, or surgical treatment by laparoscopy
    or laparotomy. The main outcome measure was
    pregnancy rates.

19
  • 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).

20
The authors urged for prospective randomized
trials to be performed to confirm these findings.
21
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.

22
  • 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

23
  • The corresponding rates of fecundity were 4.7 and
    2.4 per 100 woman-months (rate ratio, 1.9 95
    confidence interval, 1.2-3.1).

24
  • 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
    diagnostic-laparoscopy group (P0.91). The
    authors concluded that Laparoscopic resection or
    ablation of minimal and mild endometriosis
    enhances fecundity in infertile women.

25
  • 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).

26
  • 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.

27
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.

28
  • 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.

29
  • 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,
    1.022.67) noticing that the lower confidence
    interval limit is too close to unity

30
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.

31
  • The net result is that eight women with minimal
    to mild endometriosis need to undergo
    laparoscopic ablation to achieve an additional
    late pregnancy.

32
  • 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 lt50, the number needed to be treated
    doubles at least

33
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.

34
  • 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.

35
  • 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.

36
  • 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.

37
  • Many investigators are wondering if minimal or
    mild endometriosis is really a disease that needs
    treatment.

38
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

39
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.

40
  • 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.
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