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La Laparoscopia
Ludovico Muzii
Clinica Ginecologica e Ostetrica,
Università Campus Bio-Medico,
Roma
Laparoscopia Diagnostica - Operativa
• Sterilità

• Dolore pelvico cronico, acuto
• Gravidanza ectopica
• Aderenze, endometriosi
• Masse annessiali
• Isterectomia (LAVH, TLH, LSH)
• Miomi uterini
• Patologia del pavimento pelvico
• Oncologia ginecologica
Laparoscopia: accesso
• Inserimento ago di Veres
• Inserimento trocar secondo tecnica classica
• Inserimento trocar secondo tecnica diretta
• Open laparoscopy
• Trocar ottico
• Introduzione trocar accessori
Complicanze maggiori dovute all’accesso
  Garry R. Gynaecol Endosc 8:315-326, 1999

Numero           Numero                    Lesioni        x 1000   Lesioni     x1000
di studi         di procedure              intestinali             vascolari

Tecnica classica
  6              357.257                   103 0,4/1000             69         0,2/1000
Tecnica “open”
  7               20.410                     99 5,0/1000              0          //
  6*              12.410                       7 0,6/1000             0          //
Tecnica diretta
  3                 6.833                      7 1,1/1000             0         //
*escludendo lo studio AAGL (8000 casi, 92 lesioni, 12/1000)
“L’approccio ‘open’ secondo
Hasson dovrebbe essere
quello preferito in ogni caso.”

Thomas WEG: Basic surgical skills: A participants’
hanbook. Royal College of Surgeons 1996
Per evitare lesioni vascolari maggiori:
MAI DEVIARE DALLA LINEA
MEDIANA CON UN ANGOLO DI
40-45° VERSO IL BASSO (in pazienti
obese angolo maggiore)
Presenza di aderenze in relazione a pregressa
chirurgia
Audebert AJM. Gynaecol Endosc 8:363-7, 1999

 Pregressa chirurgia   Aderenze      n / 1000



 Nessuna               4 / 519     ( 8 / 1000)
 Laparoscopia          2 / 140     (14/ 1000)
 Pfannenstiel          31 / 145   (214/ 1000)
 Longitudinale         51 / 96    (531/ 1000)
Tecnica classica
Tecnica diretta
Tecnica open
Inserimento trocar accessori
Diagnosi di Fattore tubarico di
           Sterilita’

 Quale metodica?
Quando?
Medicina
              basata sulla
              EVIDENZA
• Two million articles per year in the
  biomedical literature
• A physician should read 19 articles per
  day, 365 days per year, to keep up with
  her/his specialty

                   Sackett DL, BMJ 1995
NICE guidelines




                  www.nice.org.uk
NICE guidelines

Meta-analysis based on three studies with judgement of
laparoscopy without knowledge of HSG results gave pooled
estimates of sensitivity and specificity for HSG as a test for
tubal obstruction of 0.65 and 0.83 respectively. When HSG
suggests the presence of tubal obstruction this will be
confirmed by laparoscopy in only 38% of women.Thus, HSG is
not a reliable indicator of tubal occlusion. However, when HSG
suggests that the tubes are patent, this will be confirmed at
laparoscopy in 94% of women. Thus HSG is a reliable
indicator of tubal patency.
NICE guidelines
NICE guidelines
Altre metodiche?
NICE guidelines

In conclusione:
  Se non ci sono fattori di rischio
noti, ISTEROSALPINGOGRAFIA
  Se ci sono fattori di rischio noti,
LAPAROSCOPIA
Fertil Steril 2004; www.asrm.org
Diagnosi di Fattore tubarico di Sterilita’
  Quale metodica?

A postal survey was conducted among gynecologists
and radiologists to find out the current practice in
the UK regarding the methods employed to assess
tubal patency. In the responses from radiologists, a
HSG was the investigation of choice for both low
risk (61%) and high risk women (50%). In the
responses from gynecologists, in low risk the
majority perfomred a HSG (58%) or HyCoSo
(15ì4%), whereas in high risk most (84%) performed
a laparoscopy
        Vvjayanthi S, Hum Fertil (Camb) 2004
Quando?
Quando?
      ?
   ?
    The specific definition of infertility is inability of
    a couple to conceive after 1 year of sexual
    intercourse without contraception. The initial
    diagnostic test for infertility should include a
    midulteal progesteron assay, a semen analysis
    and a test for tubal patency such as HSG.
    The ESHRE Capri Workshop Group: “Optimal
    use of infertility diagnostic tests and treatments”.
    Human Reproduction 15:723, 2000
Diagnosi di Fattore tubarico di Sterilita’
  E’ necessaria la laparoscopia dopo HSG normale?

When tubal patency has been demonstrated by HSG,
laparoscopy is traditionally suggested as a mandatory
step to preclude the existence of peritubal adhesions and
endometriosis. In women without a hystory suggestive of
tubal disease and a normal HSG, we demonstrate that
the probability of clinicallly relevant disease is very low
and laparosocpy does not seem to be justified or cost-
effective. In these cases surgery has not been proven to
improve fecundity, and we suggest 3-6 cycles of
COH/IUI, and if unsuccesful, IVF

                 Fatum M, Hum Reprod 2002
STERILITA’ DA FATTORE TUBARICO

 La sterilità da fattore tubo-peritoneale
 (aderenze pelviche, occlusioni tubariche
 prossimali e distali, endometriosi)
 rappresenta il fattore eziologico nel
 40% dei casi di sterilità femminile
Fattore Tubo-Peritoneale di Sterilita’

    Aderenze
    Occlusione tubarica distale –
  Idrosalpinge
    Occlusione tubarica prossimale
    Endometriosi
Aderenze
ADERENZE POST-CHIRURGICHE
Le aderenze, causate da PID,
pregressi interventi, endometriosi,
possono essere a loro volta causa di
sterilità, dolore pelvico cronico,
occlusione intestinale, gravidanza
extra-uterina, re-interventi
COME SI FORMANO LE ADERENZE:
    Fenomeni a livello peritoneale (5-7 giorni)
                                Peritoneum
                                          Trauma
                              Peritoneal Defect

                         Increased Vessel Permeab

                           Inflammatory Exudate
                               Fibrin Matrix
    PA
                Plasminogen    Fibrinolysis      Ischemia
    PAI

    Normal fibrinolytic activity      Suppressed fibrinolytic activity
                                                            Persistence of fibrin
       Resolution of fibrin               Fibroblast Proliferation
  Mesothelium
                                                          Organisation of fibrin matrix
                Repair
                                              Adhesion Formation
Classificazione delle Aderenze

 • Incidenza
 • Estensione
 • Severità
 • Localizzazione
Fertil Steril 1988
Incidenza


• Aderenze De Novo

• Riformazione delle Aderenze
Incidence of De Novo Adhesions

• 55% - 100% Incidence of Adhesions after Laparotomy
                                    Time from Total Total no.
                                       Inital   no. of    With     % with
                                    Procedures Patients Adhesions Adhesions

 Diamomd et al       1 wk -12 wk                           106             91                 86
 DeCherney and Mezer 4 wk - 16wk                           20              15                 75
                      1 yr - 3 yr                          41              31                 76
 Surrey and           6 wk – 8 wk                          31              22                 71
 Friedman             > 6 mo                                6              5                  83
 Pittaway et al       4 wk – 6 wk                          23              23                 100
 Trimbos-Kemper et al 8 days                               188            104                 55
 Daniell and Pittaway 4 wk – 6 wk                          25              24                 96

Adapted from Diamond MP, Surgical Aspects in Fertility. In Gynaecology and Obstetrics, 1988
Adhesion Formation & Laparoscopy
 Sites of adhesion formation following laparoscopy
                 Number of    Reformed      De Novo
                  Patients    Adhesions     Adhesions
  Diamond           62       67% tube     23% pelvic
  et al, 1991                80% ovary
  Canis et al,      42       82% adnexa   21% adnexa
  1992
  Lundorff et       31       60% tube     17% tube
  al, 1991
Aderenze post-miomectomia laparoscopica
Autore, anno        n.pz   2Look (%)   % aderenze

Mais, 1996a          25     100%          40%
Mais, 1996b          25     100%          88%
Bulletti, 1996       16      88%          29%
Dubuisson, 1998      45     100%          36%
Takeuchi, 2002      115      44%          29%
Di Gregorio, 2002   635      19%           2%
Malzoni, 2003       144      12%          33%

Total               1005   289 (29%)   25% (41%)
...THE TWO ENDS OF THE SPECTRUM:
 • Do not undertreat, or mismanage, the
  unexpected ovarian cancer

 • Do not overtreat the functional cyst

 • (Do not operate on the incidental myoma)
            Muzii and Benedetti Panici, JAAGL 2004
FUNCTIONAL CYSTS EXCISED AT
           OPERATIVE LAPAROSCOPY
                    n. of patients     Functional cysts       %
  Nezhat, 1992          1011                  358             36
  Mecke, 1992            678                  207             31
  Canis, 1994            757                  149             18
 Van Her. 1995           121                   17             14
  Sadik, 1999            220                   74             34
Rasmussen, 1999          275                   23             8
 Mettler, 2001           493                  144             29
Benedetti Panici,        282                   12             4
     2002
 Marana, 2004            658                   29             4

                       4495
                       4495                 1013
                                            1013             22.5%
                                                             22.5%
                    Muzii and Benedetti Panici, JAAGL 2004
LAPAROSCOPIC EXCISION OF
   FUNCTIONAL CYSTS

•COST OF THE PROCEDURE

•ADHESIONS

•HARMFUL OF THE OVARY

•MEDICO-LEGAL IMPLICATIONS
From Luciano AA et al, Fertil Steril, 1991
From Luciano AA et al, Fertil Steril, 1991
“...to avoid adhesions
you must avoid surgery.”

        L Mettler, Ann N Y Acad Sci, 2003
ADERENZE POST-CHIRURGICHE

Le aderenze possono essere causa
di dolore pelvico cronico, sterilità,
occlusione intestinale, gravidanza
extra-uterina, re-interventi
Pelvic Pain and Adhesions

• 15% - 45% of patients with chronic pelvic pain
  (CPP) have pelvic adhesions
• Fix internal genital organs to adjacent structures
• Compress/construct ovaries and fallopian tubes
Laparoscopy for Chronic Pelvic Pain
 80
 70
 60
 50                                              Liston et al
 40                                              Lundberg et al
                                                 Renaer
 30                                              Kresch et al
 20                                              Rapkin
 10
  0
      no pathology   adhesions   endometriosis
Pain relief after laparoscopic adhesiolysis

                         No. of     Pain Better Pain Not Better
Study                    Patients      (%)           (%)

Sutton & Macdonald, 1990       65    53 (82%)    10 (15%)
Goldstein et al., 1980         18    16 (89%)     2 (11%)
Steege & Stout, 1991           30    19 (63%)    11 (37%)
Onders and Mittendorf, 2003    70    50 (71%)    20 (29%)

Totals                        183   138 (75%)    43 (23%)
Pain & Adhesions Controversy
• Some patients have pelvic pain and no
  adhesions
• Some patients have adhesions and no pelvic
  pain
• After adhesiolysis, pain but later it could
  return or
• No RCTs
Adesiolisi?
“The best single source of reliable evidence
about the effects of health care”
                    www.cochrane.org
DJ Swank, Lancet 2003
DJ Swank, Lancet 2003
“This finding suggest that the value of laparoscopic adhesiolysis
does not lie in the adhesiolysis itself.
Adhesions do not cause pain unless they are causing an
obstruction.
Diagnostic laparoscopy could be of benefit to patients by
revealing other causes of their pain.
We recommend that clinicians consider abandoning laparoscopic
adhesiolysis as a treatment”
                              DJ Swank, Lancet 2003
L Demco, JAAGL 2004
“Filmy adhesions between a
moveable structure, such as an
ovary, and the peritoneum had
the highest pain scores. Fixed or
dense adhesions, no matter
where they were located, had
the lowest pain scores.”            L Demco, JAAGL 2004
Do not lyse the dense,
fixed, difficult adhesions.
If in doubt, lyse only the
easy adhesions
ADERENZE POST-CHIRURGICHE
 Le aderenze possono essere causa
 di dolore pelvico cronico, sterilità,
 occlusione intestinale, gravidanza
 extra-uterina, re-interventi
Role of Adhesions in Infertility

• Interference with ovum escape
• Impairment of tubal function
• Tubal occlusion


Buttram VC Jr., Reiter RC. Surgical Treatment of the Infertile Female. Baltimore, MD:
    Williams & Wilkins; 70, 1985
Gordji M. Pelvic Adhesions and Sterility. Acta Eur Fertil 6:279, 1975
Adhesions & Infertility

• Impair fertility severely

• Surgical correction only partly effective…
            - Due to mucosal damage
            - Due to adhesion reformation
Infertility
                  Cumulative Pregnancy Rates of Untreated
                  Tubal/Pelvic Damage vs Surgery
                  100
Percent Couples




                   90                                          Normal
                   80
                   70                                Grade I - Surgery
                   60
                   50                                Grade II - Surgery
                   40
                   30
                                                   Grade I - Untreated
                   20
                   10                              Grade II - Untreated
                    0
                                12            24                     36
                                  Months
Seppure in assenza di studi controllati
randomizzati, l’adesiolisi in caso di
sterilita’ e’ sicuramente indicata
Occlusione tubarica
distale (DTO)
OCCLUSIONE TUBARICA DISTALE
Fertil Steril 1988
Salpingoneostomia: creazione della neostomia con elettrodo
monopolare o con laser a CO2 ad elevata densità di potenza (spot
piccolo, potenza alta)
Eversione delle fimbrie; tale manovra viene eseguita in
laparoscopia con il laser defocalizzato o con il bipolare a
bassa potenza
Stabilizzazione della neostomia con punti. In laparoscopia
tale procedura non è necessaria
SALPINGONEOSTOMIA:
 CONFRONTO TRA LAPAROTOMIA
 E LAPAROSCOPIA

               n. pazienti   % grav.   EP
                             totali


Laparotomia    1011          34%       2-38%
Laparoscopia    370          30%       0-18%
…We recommend intraoperative salpingoscopy to
visualize the whole length of the ampullary lumen.
Whereas the status of the ampullary endosalpinx is also
an important prognostic parameter, we elected not to
include it in the scoring system at this time, since
salpingoscopy is not being practiced universally…

         The American Fertility Society, 1988
SALPINGOSCOPY
    -classification of lesions-

Grade 1: normal fold pattern
Grade 2: separation and flattening of
      folds
Grade3: focal lesion, e. g. small
      adhesions
Grade 4: extensive adhesions and/or
      disseminated flat areas
Grade 5: complete loss of folds
                          Brosens, 1987
GRADE 1-2
GRADE 3
GRADE 4
GRADE 5
CUMULATIVE TABLE OF PREGNANCIES
       -According to the salpingoscopic grade
                     of the better tube-
                                  Salpingoscopic grade
                             I       II    III    IV   V
SALPINGO-OVARIOLYSIS
Number of patients           16       1     3    3     1
Intrauterine                 11       1     0    0     0
Extrauterine                  0       0     1    0     0
SALPINGONEOSTOMY
Number of patients           10       1     2    11    3
Intrauterine                 6        1     0     0    0
Extrauterine                 0        0      0    2    0
                                   Marana 1999
PERCENTAGE OF PATIENTS WITH
        NORMAL TUBAL MUCOSA:
          ADNEXAL ADHESIONS




  Marana (1995)               76%
  Brosens (1996)              80%

Expected intrauterine pregnancy rate: 70%
PERCENTAGE OF PATIENTS WITH
        NORMAL TUBAL MUCOSA:
            HYDROSALPINGES



   Marana (1995)               42%
   Brosens (1996)              34%


Expected intrauterine pregnancy rate: 60%
Occlusione tubarica
prossimale (PTO)
Anastomosi tubo-tubarica (in caso di “reversal”): apposizione
di un punto sul mesosalpinge e del primo punto a ore 6
Completamento del primo strato con punti a ore 3, 9 e 12
Louise Brown, born July 25, 1978



JP Toner, Fertil Steril 2002
Al di la’ di ogni discussione di tipo
etico, medico, economico, va
salvaguardata la discussione sulle
INDICAZIONI !
DIAGNOSI ISTEROSALPINGOGRAFICA
PREOPERATORIA DI OCCLUSIONE
TUBARICA: QUANTI FALSI POSITIVI
RIVELATI POI ALLA CHIRURGIA?


Occlusione prossimale     41-61%
Occlusione distale         12%
CONCLUSIONI
• Appropriata selezione delle
pazienti e rispetto delle indicazioni
• Conoscere i vantaggi ed i limiti della
chirurgia della sterilità
• Corretta informazione alla paziente
video
Come prevenire le aderenze in
corso di chirurgia annessiale?
In letteratura è disponibile un’ampia
serie di dati, sia sperimentali che clinici,
ma a tutt’oggi non esiste un metodo
universalmente accettato per la
prevenzione delle aderenze
For laparoscopy, the perceived
                                  postoperative de novo adhesion
                                  formation rate was 0%-25%,
                                  whereas the adhesion reformation
                                  rate was 26%-75%; for
                                  laparotomy, the rates were 26%-
                                  75% and >75%, respectively.

Sixty-five percent of the respondents were using at least one
method for postoperative adhesion prevention during
laparoscopy, and 68% during laparotomy.The most frequently
used method during laparoscopy was Ringer's lactate (77% of
the respondents), followed by ferric hyaluronate gel (46% of
the respondents), and 4% icodextrin (39% of respondents).
During laparotomy, the most frequently used methods were
Ringer's lactate (28%), normal saline (20%), and 4%
icodextrin (20%). Antibiotic prophylaxis was used by 87.5% of
respondents.
                                             Muzii, JAAGL 2004
Crystalloid Solutions
• Continuous irrigation is positive because:
   – prevents fibrin deposition and wash away fibrinous exudates
   – it can keep the tissues moist

• Intraperitoneal solutions at the end of surgery:
   – active on all peritoneal surfaces, possibly preventing de novo
   – easy to use, reduced costs


• However, doubts on the efficacy:
   – rate of absorption is 35 ml/hour
   – 300 ml are absorbed in 8.5 hours
   – the process of peritoneal healing and adhesion formation takes
     place during the first 5-7 days
INTRAPERITONEAL RESIDENCE OF RINGER’S
          LACTATE: LONGER THAN EXPECTED
      Results from a randomized, double-blind, clinical trial




   Kurt Semm Award, AAGL 2003


PRELIMINARY STUDY
                   ESTIMATED IP VOLUME          (mL) =

        -4x10-8 V 4 + 4x10-5 V 3 – 1.32x10-2 V2 + 2,45V + 3,4217
V = D1 x D2 x D3
RESULTS

                                               96

                  24
         0

                                     48
TIME (hrs)   RINGER mL           CONTROL mL          P
0                  289 (+ 38)             18 (+12) p<0.05
24                  185 (+72)                 3 (+2) p<0.05
48                   55 (+28)                 7 (+3) p<0.05
96                     18 (+6)                6 (+4) N.S.
Mechanical Separation of Raw Surfaces
• Liquid Instillates
   –   Cystalloid solutions (i.e. Lactated Ringer’s)
   –   Hyskon (32% dextran 70)
   –   Intergel
   –   Adept
   –   Spraygel
   –   Hyalobarrier
   –   Sepracoat

• Mechanical Separation via barriers
   – Interceed
   – Preclude (Gore-tex)
   – Seprafilm
www.cochrane.org
Cochrane menstrual disorders
              and subfertility group


Reviews:
• Barrier agents for preventing
adhesions after surgery for subfertility
• Liquid and fluid agents for
preventing adhesions after surgery for
subfertility
AGENTI DI BARRIERA


• 15 RCTs
• LPTM = 9, LPS = 6
• Aderenze pelviche 6, Miomectomia 5, Chirurgia
ovarica 4, Endometriosi 2, Indicazioni varie 1
• 13 studi: Interceed vs. controllo, 2 studi: Interceed vs.
Gore-Tex, 1 studio: Gore-Tex vs. controllo, 1 studio:
Seprafilm vs. controllo
• In nessuno studio sono state valutate Gravidanze e
Riduzione del dolore
AGENTI DI BARRIERA


• L’uso dell’Interceed e’ associato ad una minore incidenza
di formazione di aderenze (sia ri-formazione che
formazione de novo) dopo chirugia laparoscopica e
laparotomica
• Il Gore-Tex e’ piu’ efficace di nessun trattamento o di
Interceed
• Evidenze limitate sull’efficacia del Seprafilm per la
prevenzione di aderenze dopo miomectomia
• Interceed efficace nel ridurre le aderenze, ma dati
insufficienti per raccomandarne l’uso per migliorare le
percentuali di gravidanza
AGENTI LIQUIDI / FLUIDI


• Nessuno degli agenti liquidi o fluidi studiati ha
determinato un aumento delle percentuali di gravidanza.
• Alcune evidenze sull’efficacia degli steroidi nel ridurre
l’incidenza e la severita’ della formazione di aderenze.
Destrano inefficace.
• L’uso di routine di questi agenti non puo’ essere
raccomandato sulla base delle evidenze disponibili.
• L’evidenza sugli steroidi e’ ben lontana dall’essere
perfetta, ma suggerisce l’efficacia. Dovrebbero essere
condotti studi addizionali.
Intergel




Adept
DB Johns, Fertil Steril 2001
“You should
immediately
discontinue use
of the device”
March 2003
Hum Reprod. 2002 Apr;17(4):1031-8.

A randomized, controlled pilot study of the safety and efficacy of
4% icodextrin solution in the reduction of adhesions following
laparoscopic gynaecological surgery.

diZerega GS, Verco SJ, Young P, Kettel M, Kobak W, Martin D, Sanfilippo J, Peers EM,
Scrimgeour A, Brown CB.

University of Southern California Keck School of Medicine, Los Angeles, CA, IGO Medical
Group, San Diego Fertility Center, Private Practice, Memphis TN, and ML Laboratories PLC,
Leicester, UK.




                                                                     DiZerega, 2002
P = n.s.
CONCLUSIONI - Aderenze
Nonostante l’enorme mole di dati presenti in
letteratura, non esiste oggi un approccio
universalmente accettato. L’Interceed è il
metodo sul quale oggi esistono più studi. Nuovi
metodi di barriera in studio. L’approccio
laparoscopico, probabilmente, determina una
riduzione delle aderenze “de novo”. La
riformazione delle aderenze dopo adesiolisi
sembra invece essere la norma più che
l’eccezione, anche in laparoscopia.
CONCLUSIONI
La corretta indicazione all’intervento chirurgico
è probabilmente il mezzo più efficace per
prevenire le aderenze postoperatorie.
L’accurata selezione delle pazienti e il rispetto
delle indicazioni sono i punti-chiave per ottenere
i migliori risultati in chirurgia laparoscopica del
fattore tubo-peritoneale di sterilità
L’utilizzo di tecniche chirurgiche nel rispetto dei
tessuti è l’altro punto fondamentale.
Grazie per l’attenzione!

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La laparoscopia diagnostica

  • 1. La Laparoscopia Ludovico Muzii Clinica Ginecologica e Ostetrica, Università Campus Bio-Medico, Roma
  • 2.
  • 3. Laparoscopia Diagnostica - Operativa • Sterilità • Dolore pelvico cronico, acuto • Gravidanza ectopica • Aderenze, endometriosi • Masse annessiali • Isterectomia (LAVH, TLH, LSH) • Miomi uterini • Patologia del pavimento pelvico • Oncologia ginecologica
  • 4. Laparoscopia: accesso • Inserimento ago di Veres • Inserimento trocar secondo tecnica classica • Inserimento trocar secondo tecnica diretta • Open laparoscopy • Trocar ottico • Introduzione trocar accessori
  • 5. Complicanze maggiori dovute all’accesso Garry R. Gynaecol Endosc 8:315-326, 1999 Numero Numero Lesioni x 1000 Lesioni x1000 di studi di procedure intestinali vascolari Tecnica classica 6 357.257 103 0,4/1000 69 0,2/1000 Tecnica “open” 7 20.410 99 5,0/1000 0 // 6* 12.410 7 0,6/1000 0 // Tecnica diretta 3 6.833 7 1,1/1000 0 // *escludendo lo studio AAGL (8000 casi, 92 lesioni, 12/1000)
  • 6. “L’approccio ‘open’ secondo Hasson dovrebbe essere quello preferito in ogni caso.” Thomas WEG: Basic surgical skills: A participants’ hanbook. Royal College of Surgeons 1996
  • 7. Per evitare lesioni vascolari maggiori: MAI DEVIARE DALLA LINEA MEDIANA CON UN ANGOLO DI 40-45° VERSO IL BASSO (in pazienti obese angolo maggiore)
  • 8. Presenza di aderenze in relazione a pregressa chirurgia Audebert AJM. Gynaecol Endosc 8:363-7, 1999 Pregressa chirurgia Aderenze n / 1000 Nessuna 4 / 519 ( 8 / 1000) Laparoscopia 2 / 140 (14/ 1000) Pfannenstiel 31 / 145 (214/ 1000) Longitudinale 51 / 96 (531/ 1000)
  • 13. Diagnosi di Fattore tubarico di Sterilita’ Quale metodica? Quando?
  • 14. Medicina basata sulla EVIDENZA • Two million articles per year in the biomedical literature • A physician should read 19 articles per day, 365 days per year, to keep up with her/his specialty Sackett DL, BMJ 1995
  • 15. NICE guidelines www.nice.org.uk
  • 16. NICE guidelines Meta-analysis based on three studies with judgement of laparoscopy without knowledge of HSG results gave pooled estimates of sensitivity and specificity for HSG as a test for tubal obstruction of 0.65 and 0.83 respectively. When HSG suggests the presence of tubal obstruction this will be confirmed by laparoscopy in only 38% of women.Thus, HSG is not a reliable indicator of tubal occlusion. However, when HSG suggests that the tubes are patent, this will be confirmed at laparoscopy in 94% of women. Thus HSG is a reliable indicator of tubal patency.
  • 19. NICE guidelines In conclusione: Se non ci sono fattori di rischio noti, ISTEROSALPINGOGRAFIA Se ci sono fattori di rischio noti, LAPAROSCOPIA
  • 20. Fertil Steril 2004; www.asrm.org
  • 21. Diagnosi di Fattore tubarico di Sterilita’ Quale metodica? A postal survey was conducted among gynecologists and radiologists to find out the current practice in the UK regarding the methods employed to assess tubal patency. In the responses from radiologists, a HSG was the investigation of choice for both low risk (61%) and high risk women (50%). In the responses from gynecologists, in low risk the majority perfomred a HSG (58%) or HyCoSo (15ì4%), whereas in high risk most (84%) performed a laparoscopy Vvjayanthi S, Hum Fertil (Camb) 2004
  • 23. Quando? ? ? The specific definition of infertility is inability of a couple to conceive after 1 year of sexual intercourse without contraception. The initial diagnostic test for infertility should include a midulteal progesteron assay, a semen analysis and a test for tubal patency such as HSG. The ESHRE Capri Workshop Group: “Optimal use of infertility diagnostic tests and treatments”. Human Reproduction 15:723, 2000
  • 24. Diagnosi di Fattore tubarico di Sterilita’ E’ necessaria la laparoscopia dopo HSG normale? When tubal patency has been demonstrated by HSG, laparoscopy is traditionally suggested as a mandatory step to preclude the existence of peritubal adhesions and endometriosis. In women without a hystory suggestive of tubal disease and a normal HSG, we demonstrate that the probability of clinicallly relevant disease is very low and laparosocpy does not seem to be justified or cost- effective. In these cases surgery has not been proven to improve fecundity, and we suggest 3-6 cycles of COH/IUI, and if unsuccesful, IVF Fatum M, Hum Reprod 2002
  • 25. STERILITA’ DA FATTORE TUBARICO La sterilità da fattore tubo-peritoneale (aderenze pelviche, occlusioni tubariche prossimali e distali, endometriosi) rappresenta il fattore eziologico nel 40% dei casi di sterilità femminile
  • 26. Fattore Tubo-Peritoneale di Sterilita’ Aderenze Occlusione tubarica distale – Idrosalpinge Occlusione tubarica prossimale Endometriosi
  • 28. ADERENZE POST-CHIRURGICHE Le aderenze, causate da PID, pregressi interventi, endometriosi, possono essere a loro volta causa di sterilità, dolore pelvico cronico, occlusione intestinale, gravidanza extra-uterina, re-interventi
  • 29. COME SI FORMANO LE ADERENZE: Fenomeni a livello peritoneale (5-7 giorni) Peritoneum Trauma Peritoneal Defect Increased Vessel Permeab Inflammatory Exudate Fibrin Matrix PA Plasminogen Fibrinolysis Ischemia PAI Normal fibrinolytic activity Suppressed fibrinolytic activity Persistence of fibrin Resolution of fibrin Fibroblast Proliferation Mesothelium Organisation of fibrin matrix Repair Adhesion Formation
  • 30. Classificazione delle Aderenze • Incidenza • Estensione • Severità • Localizzazione
  • 32. Incidenza • Aderenze De Novo • Riformazione delle Aderenze
  • 33. Incidence of De Novo Adhesions • 55% - 100% Incidence of Adhesions after Laparotomy Time from Total Total no. Inital no. of With % with Procedures Patients Adhesions Adhesions Diamomd et al 1 wk -12 wk 106 91 86 DeCherney and Mezer 4 wk - 16wk 20 15 75 1 yr - 3 yr 41 31 76 Surrey and 6 wk – 8 wk 31 22 71 Friedman > 6 mo 6 5 83 Pittaway et al 4 wk – 6 wk 23 23 100 Trimbos-Kemper et al 8 days 188 104 55 Daniell and Pittaway 4 wk – 6 wk 25 24 96 Adapted from Diamond MP, Surgical Aspects in Fertility. In Gynaecology and Obstetrics, 1988
  • 34. Adhesion Formation & Laparoscopy Sites of adhesion formation following laparoscopy Number of Reformed De Novo Patients Adhesions Adhesions Diamond 62 67% tube 23% pelvic et al, 1991 80% ovary Canis et al, 42 82% adnexa 21% adnexa 1992 Lundorff et 31 60% tube 17% tube al, 1991
  • 35. Aderenze post-miomectomia laparoscopica Autore, anno n.pz 2Look (%) % aderenze Mais, 1996a 25 100% 40% Mais, 1996b 25 100% 88% Bulletti, 1996 16 88% 29% Dubuisson, 1998 45 100% 36% Takeuchi, 2002 115 44% 29% Di Gregorio, 2002 635 19% 2% Malzoni, 2003 144 12% 33% Total 1005 289 (29%) 25% (41%)
  • 36. ...THE TWO ENDS OF THE SPECTRUM: • Do not undertreat, or mismanage, the unexpected ovarian cancer • Do not overtreat the functional cyst • (Do not operate on the incidental myoma) Muzii and Benedetti Panici, JAAGL 2004
  • 37. FUNCTIONAL CYSTS EXCISED AT OPERATIVE LAPAROSCOPY n. of patients Functional cysts % Nezhat, 1992 1011 358 36 Mecke, 1992 678 207 31 Canis, 1994 757 149 18 Van Her. 1995 121 17 14 Sadik, 1999 220 74 34 Rasmussen, 1999 275 23 8 Mettler, 2001 493 144 29 Benedetti Panici, 282 12 4 2002 Marana, 2004 658 29 4 4495 4495 1013 1013 22.5% 22.5% Muzii and Benedetti Panici, JAAGL 2004
  • 38. LAPAROSCOPIC EXCISION OF FUNCTIONAL CYSTS •COST OF THE PROCEDURE •ADHESIONS •HARMFUL OF THE OVARY •MEDICO-LEGAL IMPLICATIONS
  • 39. From Luciano AA et al, Fertil Steril, 1991 From Luciano AA et al, Fertil Steril, 1991
  • 40. “...to avoid adhesions you must avoid surgery.” L Mettler, Ann N Y Acad Sci, 2003
  • 41. ADERENZE POST-CHIRURGICHE Le aderenze possono essere causa di dolore pelvico cronico, sterilità, occlusione intestinale, gravidanza extra-uterina, re-interventi
  • 42. Pelvic Pain and Adhesions • 15% - 45% of patients with chronic pelvic pain (CPP) have pelvic adhesions • Fix internal genital organs to adjacent structures • Compress/construct ovaries and fallopian tubes
  • 43. Laparoscopy for Chronic Pelvic Pain 80 70 60 50 Liston et al 40 Lundberg et al Renaer 30 Kresch et al 20 Rapkin 10 0 no pathology adhesions endometriosis
  • 44. Pain relief after laparoscopic adhesiolysis No. of Pain Better Pain Not Better Study Patients (%) (%) Sutton & Macdonald, 1990 65 53 (82%) 10 (15%) Goldstein et al., 1980 18 16 (89%) 2 (11%) Steege & Stout, 1991 30 19 (63%) 11 (37%) Onders and Mittendorf, 2003 70 50 (71%) 20 (29%) Totals 183 138 (75%) 43 (23%)
  • 45. Pain & Adhesions Controversy • Some patients have pelvic pain and no adhesions • Some patients have adhesions and no pelvic pain • After adhesiolysis, pain but later it could return or • No RCTs
  • 47. “The best single source of reliable evidence about the effects of health care” www.cochrane.org
  • 50. “This finding suggest that the value of laparoscopic adhesiolysis does not lie in the adhesiolysis itself. Adhesions do not cause pain unless they are causing an obstruction. Diagnostic laparoscopy could be of benefit to patients by revealing other causes of their pain. We recommend that clinicians consider abandoning laparoscopic adhesiolysis as a treatment” DJ Swank, Lancet 2003
  • 52. “Filmy adhesions between a moveable structure, such as an ovary, and the peritoneum had the highest pain scores. Fixed or dense adhesions, no matter where they were located, had the lowest pain scores.” L Demco, JAAGL 2004
  • 53. Do not lyse the dense, fixed, difficult adhesions. If in doubt, lyse only the easy adhesions
  • 54. ADERENZE POST-CHIRURGICHE Le aderenze possono essere causa di dolore pelvico cronico, sterilità, occlusione intestinale, gravidanza extra-uterina, re-interventi
  • 55. Role of Adhesions in Infertility • Interference with ovum escape • Impairment of tubal function • Tubal occlusion Buttram VC Jr., Reiter RC. Surgical Treatment of the Infertile Female. Baltimore, MD: Williams & Wilkins; 70, 1985 Gordji M. Pelvic Adhesions and Sterility. Acta Eur Fertil 6:279, 1975
  • 56. Adhesions & Infertility • Impair fertility severely • Surgical correction only partly effective… - Due to mucosal damage - Due to adhesion reformation
  • 57. Infertility Cumulative Pregnancy Rates of Untreated Tubal/Pelvic Damage vs Surgery 100 Percent Couples 90 Normal 80 70 Grade I - Surgery 60 50 Grade II - Surgery 40 30 Grade I - Untreated 20 10 Grade II - Untreated 0 12 24 36 Months
  • 58. Seppure in assenza di studi controllati randomizzati, l’adesiolisi in caso di sterilita’ e’ sicuramente indicata
  • 62.
  • 63. Salpingoneostomia: creazione della neostomia con elettrodo monopolare o con laser a CO2 ad elevata densità di potenza (spot piccolo, potenza alta)
  • 64.
  • 65.
  • 66. Eversione delle fimbrie; tale manovra viene eseguita in laparoscopia con il laser defocalizzato o con il bipolare a bassa potenza
  • 67. Stabilizzazione della neostomia con punti. In laparoscopia tale procedura non è necessaria
  • 68. SALPINGONEOSTOMIA: CONFRONTO TRA LAPAROTOMIA E LAPAROSCOPIA n. pazienti % grav. EP totali Laparotomia 1011 34% 2-38% Laparoscopia 370 30% 0-18%
  • 69. …We recommend intraoperative salpingoscopy to visualize the whole length of the ampullary lumen. Whereas the status of the ampullary endosalpinx is also an important prognostic parameter, we elected not to include it in the scoring system at this time, since salpingoscopy is not being practiced universally… The American Fertility Society, 1988
  • 70.
  • 71.
  • 72. SALPINGOSCOPY -classification of lesions- Grade 1: normal fold pattern Grade 2: separation and flattening of folds Grade3: focal lesion, e. g. small adhesions Grade 4: extensive adhesions and/or disseminated flat areas Grade 5: complete loss of folds Brosens, 1987
  • 77. CUMULATIVE TABLE OF PREGNANCIES -According to the salpingoscopic grade of the better tube- Salpingoscopic grade I II III IV V SALPINGO-OVARIOLYSIS Number of patients 16 1 3 3 1 Intrauterine 11 1 0 0 0 Extrauterine 0 0 1 0 0 SALPINGONEOSTOMY Number of patients 10 1 2 11 3 Intrauterine 6 1 0 0 0 Extrauterine 0 0 0 2 0 Marana 1999
  • 78. PERCENTAGE OF PATIENTS WITH NORMAL TUBAL MUCOSA: ADNEXAL ADHESIONS Marana (1995) 76% Brosens (1996) 80% Expected intrauterine pregnancy rate: 70%
  • 79. PERCENTAGE OF PATIENTS WITH NORMAL TUBAL MUCOSA: HYDROSALPINGES Marana (1995) 42% Brosens (1996) 34% Expected intrauterine pregnancy rate: 60%
  • 81.
  • 82. Anastomosi tubo-tubarica (in caso di “reversal”): apposizione di un punto sul mesosalpinge e del primo punto a ore 6
  • 83. Completamento del primo strato con punti a ore 3, 9 e 12
  • 84.
  • 85. Louise Brown, born July 25, 1978 JP Toner, Fertil Steril 2002
  • 86. Al di la’ di ogni discussione di tipo etico, medico, economico, va salvaguardata la discussione sulle INDICAZIONI !
  • 87. DIAGNOSI ISTEROSALPINGOGRAFICA PREOPERATORIA DI OCCLUSIONE TUBARICA: QUANTI FALSI POSITIVI RIVELATI POI ALLA CHIRURGIA? Occlusione prossimale 41-61% Occlusione distale 12%
  • 88. CONCLUSIONI • Appropriata selezione delle pazienti e rispetto delle indicazioni • Conoscere i vantaggi ed i limiti della chirurgia della sterilità • Corretta informazione alla paziente
  • 89. video
  • 90. Come prevenire le aderenze in corso di chirurgia annessiale?
  • 91. In letteratura è disponibile un’ampia serie di dati, sia sperimentali che clinici, ma a tutt’oggi non esiste un metodo universalmente accettato per la prevenzione delle aderenze
  • 92. For laparoscopy, the perceived postoperative de novo adhesion formation rate was 0%-25%, whereas the adhesion reformation rate was 26%-75%; for laparotomy, the rates were 26%- 75% and >75%, respectively. Sixty-five percent of the respondents were using at least one method for postoperative adhesion prevention during laparoscopy, and 68% during laparotomy.The most frequently used method during laparoscopy was Ringer's lactate (77% of the respondents), followed by ferric hyaluronate gel (46% of the respondents), and 4% icodextrin (39% of respondents). During laparotomy, the most frequently used methods were Ringer's lactate (28%), normal saline (20%), and 4% icodextrin (20%). Antibiotic prophylaxis was used by 87.5% of respondents. Muzii, JAAGL 2004
  • 93. Crystalloid Solutions • Continuous irrigation is positive because: – prevents fibrin deposition and wash away fibrinous exudates – it can keep the tissues moist • Intraperitoneal solutions at the end of surgery: – active on all peritoneal surfaces, possibly preventing de novo – easy to use, reduced costs • However, doubts on the efficacy: – rate of absorption is 35 ml/hour – 300 ml are absorbed in 8.5 hours – the process of peritoneal healing and adhesion formation takes place during the first 5-7 days
  • 94. INTRAPERITONEAL RESIDENCE OF RINGER’S LACTATE: LONGER THAN EXPECTED Results from a randomized, double-blind, clinical trial Kurt Semm Award, AAGL 2003 PRELIMINARY STUDY ESTIMATED IP VOLUME (mL) = -4x10-8 V 4 + 4x10-5 V 3 – 1.32x10-2 V2 + 2,45V + 3,4217 V = D1 x D2 x D3
  • 95. RESULTS 96 24 0 48 TIME (hrs) RINGER mL CONTROL mL P 0 289 (+ 38) 18 (+12) p<0.05 24 185 (+72) 3 (+2) p<0.05 48 55 (+28) 7 (+3) p<0.05 96 18 (+6) 6 (+4) N.S.
  • 96. Mechanical Separation of Raw Surfaces • Liquid Instillates – Cystalloid solutions (i.e. Lactated Ringer’s) – Hyskon (32% dextran 70) – Intergel – Adept – Spraygel – Hyalobarrier – Sepracoat • Mechanical Separation via barriers – Interceed – Preclude (Gore-tex) – Seprafilm
  • 98. Cochrane menstrual disorders and subfertility group Reviews: • Barrier agents for preventing adhesions after surgery for subfertility • Liquid and fluid agents for preventing adhesions after surgery for subfertility
  • 99. AGENTI DI BARRIERA • 15 RCTs • LPTM = 9, LPS = 6 • Aderenze pelviche 6, Miomectomia 5, Chirurgia ovarica 4, Endometriosi 2, Indicazioni varie 1 • 13 studi: Interceed vs. controllo, 2 studi: Interceed vs. Gore-Tex, 1 studio: Gore-Tex vs. controllo, 1 studio: Seprafilm vs. controllo • In nessuno studio sono state valutate Gravidanze e Riduzione del dolore
  • 100. AGENTI DI BARRIERA • L’uso dell’Interceed e’ associato ad una minore incidenza di formazione di aderenze (sia ri-formazione che formazione de novo) dopo chirugia laparoscopica e laparotomica • Il Gore-Tex e’ piu’ efficace di nessun trattamento o di Interceed • Evidenze limitate sull’efficacia del Seprafilm per la prevenzione di aderenze dopo miomectomia • Interceed efficace nel ridurre le aderenze, ma dati insufficienti per raccomandarne l’uso per migliorare le percentuali di gravidanza
  • 101. AGENTI LIQUIDI / FLUIDI • Nessuno degli agenti liquidi o fluidi studiati ha determinato un aumento delle percentuali di gravidanza. • Alcune evidenze sull’efficacia degli steroidi nel ridurre l’incidenza e la severita’ della formazione di aderenze. Destrano inefficace. • L’uso di routine di questi agenti non puo’ essere raccomandato sulla base delle evidenze disponibili. • L’evidenza sugli steroidi e’ ben lontana dall’essere perfetta, ma suggerisce l’efficacia. Dovrebbero essere condotti studi addizionali.
  • 103. DB Johns, Fertil Steril 2001
  • 104. “You should immediately discontinue use of the device” March 2003
  • 105. Hum Reprod. 2002 Apr;17(4):1031-8. A randomized, controlled pilot study of the safety and efficacy of 4% icodextrin solution in the reduction of adhesions following laparoscopic gynaecological surgery. diZerega GS, Verco SJ, Young P, Kettel M, Kobak W, Martin D, Sanfilippo J, Peers EM, Scrimgeour A, Brown CB. University of Southern California Keck School of Medicine, Los Angeles, CA, IGO Medical Group, San Diego Fertility Center, Private Practice, Memphis TN, and ML Laboratories PLC, Leicester, UK. DiZerega, 2002 P = n.s.
  • 106. CONCLUSIONI - Aderenze Nonostante l’enorme mole di dati presenti in letteratura, non esiste oggi un approccio universalmente accettato. L’Interceed è il metodo sul quale oggi esistono più studi. Nuovi metodi di barriera in studio. L’approccio laparoscopico, probabilmente, determina una riduzione delle aderenze “de novo”. La riformazione delle aderenze dopo adesiolisi sembra invece essere la norma più che l’eccezione, anche in laparoscopia.
  • 107. CONCLUSIONI La corretta indicazione all’intervento chirurgico è probabilmente il mezzo più efficace per prevenire le aderenze postoperatorie. L’accurata selezione delle pazienti e il rispetto delle indicazioni sono i punti-chiave per ottenere i migliori risultati in chirurgia laparoscopica del fattore tubo-peritoneale di sterilità L’utilizzo di tecniche chirurgiche nel rispetto dei tessuti è l’altro punto fondamentale.