la laparoscopia diagnostica
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La LaparoscopiaLudovico Muzii
Clinica Ginecologica e Ostetrica, Università Campus Bio-Medico, Roma
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Laparoscopia Diagnostica Laparoscopia Diagnostica -- OperativaOperativa•• SterilitSterilitàà
•• Dolore pelvico cronico, acutoDolore pelvico cronico, acuto
•• Gravidanza Gravidanza ectopicaectopica
•• Aderenze, Aderenze, endometriosiendometriosi
•• Masse Masse annessialiannessiali
•• Isterectomia (LAVH, TLH, LSH)Isterectomia (LAVH, TLH, LSH)
•• MiomiMiomi uteriniuterini
•• Patologia del pavimento pelvicoPatologia del pavimento pelvico
•• Oncologia ginecologicaOncologia ginecologica
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Laparoscopia: accessoLaparoscopia: accesso
• Inserimento ago di Veres
• Inserimento trocar secondo tecnica classica
• Inserimento trocar secondo tecnica diretta
• Open laparoscopy
• Trocar ottico
• Introduzione trocar accessori
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Complicanze maggiori dovute all’accessoGarry R. Gynaecol Endosc 8:315-326, 1999
Tecnica classicaTecnica classica
66 357.257357.257 103103 0,4/10000,4/1000 6969 0,2/10000,2/1000
Tecnica Tecnica ““openopen””
77 20.41020.410 9999 5,0/10005,0/1000 00 ////
6*6* 12.41012.410 77 0,6/10000,6/1000 00 ////
Tecnica direttaTecnica diretta
33 6.8336.833 77 1,1/10001,1/1000 00 ////
NumeroNumero Numero Numero LesioniLesioni x 1000x 1000 LesioniLesioni x1000x1000
di studidi studi di procedure di procedure intestinaliintestinali vascolarivascolari
*escludendo lo studio AAGL (8000 casi, 92 lesioni, 12/1000)*escludendo lo studio AAGL (8000 casi, 92 lesioni, 12/1000)
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““LL’’approccio approccio ‘‘openopen’’ secondo secondo HassonHasson dovrebbe essere dovrebbe essere quello preferito in ogni caso.quello preferito in ogni caso.””
ThomasThomas WEG: Basic WEG: Basic surgicalsurgical skillsskills: A : A participantsparticipants’’hanbookhanbook. . RoyalRoyal College of College of SurgeonsSurgeons 1996 1996
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Per evitare lesioni vascolari maggiori: Per evitare lesioni vascolari maggiori: MAI DEVIARE DALLA LINEA MAI DEVIARE DALLA LINEA MEDIANA CON UN ANGOLO DI MEDIANA CON UN ANGOLO DI 4040--4545°° VERSO IL BASSO (in pazienti VERSO IL BASSO (in pazienti obese angolo maggiore)obese angolo maggiore)
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Presenza di aderenze in relazione a pregressa chirurgiaAudebert AJM. Gynaecol Endosc 8:363-7, 1999
Pregressa chirurgiaPregressa chirurgia AderenzeAderenze n / 1000n / 1000
NessunaNessuna 4 / 5194 / 519 ( 8 / 1000)( 8 / 1000)
LaparoscopiaLaparoscopia 2 / 1402 / 140 (14/ 1000)(14/ 1000)
PfannenstielPfannenstiel 31 / 14531 / 145 (214/ 1000)(214/ 1000)
LongitudinaleLongitudinale 51 / 9651 / 96 (531/ 1000)(531/ 1000)
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Tecnica classicaTecnica classica
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Tecnica direttaTecnica diretta
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Tecnica openTecnica open
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Inserimento trocar accessoriInserimento trocar accessori
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Diagnosi di Fattore tubarico di Sterilita’
Quale metodica?
Quando?
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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
SackettSackett DL, BMJ 1995DL, BMJ 1995
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NICE NICE guidelinesguidelines
www.nice.org.ukwww.nice.org.uk
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NICE NICE guidelinesguidelines
MetaMeta--analysisanalysis basedbased on on threethree studiesstudies withwith judgementjudgement of of laparoscopy laparoscopy withoutwithout knowledgeknowledge of HSG of HSG resultsresults gavegave pooledpooledestimatesestimates of of sensitivitysensitivity and and specificityspecificity forfor HSG HSG asas a test a test forfortubaltubal obstructionobstruction of of 0.65 and 0.830.65 and 0.83 respectivelyrespectively. . WhenWhen HSG HSG suggestssuggests the the presencepresence of of tubaltubal obstructionobstruction thisthis will be will be confirmedconfirmed byby laparoscopy in laparoscopy in onlyonly 38%38% of of women.Thuswomen.Thus, HSG , HSG isisnotnot a a reliablereliable indicatorindicator of of tubaltubal occlusionocclusion. . HoweverHowever, , whenwhen HSG HSG suggestssuggests thatthat the the tubestubes are are patentpatent, , thisthis will be will be confirmedconfirmed at at laparoscopy in 94%laparoscopy in 94% of of womenwomen. . ThusThus HSG HSG isis a a reliablereliableindicatorindicator of of tubaltubal patencypatency..
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NICE NICE guidelinesguidelines
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NICE NICE guidelinesguidelinesAltre metodiche?Altre metodiche?
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NICE NICE guidelinesguidelines
In conclusione: In conclusione:
Se non ci sono fattori di rischio Se non ci sono fattori di rischio noti, ISTEROSALPINGOGRAFIAnoti, ISTEROSALPINGOGRAFIA
Se ci sono fattori di rischio noti, Se ci sono fattori di rischio noti, LAPAROSCOPIALAPAROSCOPIA
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FertilFertil SterilSteril 2004; www.asrm.org2004; www.asrm.org
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Diagnosi di Fattore tubarico di Sterilita’Quale metodica?
A A postalpostal surveysurvey waswas conductedconducted amongamong gynecologistsgynecologistsand and radiologistsradiologists toto findfind out the out the currentcurrent practicepractice in in the UK the UK regardingregarding the the methodsmethods employedemployed toto assessassesstubaltubal patencypatency. In the . In the responsesresponses fromfrom radiologistsradiologists, a , a HSG HSG waswas the the investigationinvestigation of of choicechoice forfor bothboth lowlowriskrisk (61%) and high (61%) and high riskrisk womenwomen (50%). In the (50%). In the responsesresponses fromfrom gynecologistsgynecologists, in , in lowlow riskrisk the the majority majority perfomredperfomred a HSG (58%) or a HSG (58%) or HyCoSoHyCoSo(15(15ìì4%), 4%), whereaswhereas in high in high riskrisk mostmost (84%) (84%) performedperformeda laparoscopya laparoscopy
VvjayanthiVvjayanthi S, S, HumHum FertilFertil ((CambCamb) 2004) 2004
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Quando?
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Quando??
?The The specificspecific definitiondefinition of of infertilityinfertility isis inabilityinability of of a a couplecouple toto conceiveconceive after 1 after 1 yearyear of of sexualsexualintercourseintercourse withoutwithout contraceptioncontraception. The . The initialinitialdiagnosticdiagnostic test test forfor infertilityinfertility shouldshould include a include a midultealmidulteal progesteronprogesteron assayassay, a , a semensemen analysisanalysisand a test and a test forfor tubaltubal patencypatency suchsuch asas HSG.HSG.
The ESHRE Capri Workshop The ESHRE Capri Workshop GroupGroup: : ““OptimalOptimaluseuse of of infertilityinfertility diagnosticdiagnostic teststests and and treatmentstreatments””. . HumanHuman ReproductionReproduction 15:723, 200015:723, 2000
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Diagnosi di Fattore tubarico di Sterilita’E’ necessaria la laparoscopia dopo HSG normale?
WhenWhen tubaltubal patencypatency hashas beenbeen demonstrateddemonstrated byby HSG, HSG, laparoscopy laparoscopy isis traditionallytraditionally suggestedsuggested asas a a mandatorymandatorystepstep toto preclude the preclude the existenceexistence of of peritubalperitubal adhesionsadhesions and and endometriosisendometriosis. In . In womenwomen withoutwithout a a hystoryhystory suggestive of suggestive of tubaltubal diseasedisease and a and a normalnormal HSG, HSG, wewe demonstratedemonstrate thatthatthe the probabilityprobability of of clinicalllyclinicallly relevantrelevant diseasedisease isis veryvery lowlowand and laparosocpylaparosocpy doesdoes notnot seemseem toto be be justifiedjustified or or costcost--effectiveeffective. In . In thesethese casescases surgerysurgery hashas notnot beenbeen provenproven totoimproveimprove fecundityfecundity, and , and wewe suggestsuggest 33--6 6 cyclescycles of of COH/IUI, and COH/IUI, and ifif unsuccesfulunsuccesful, IVF, IVF
FatumFatum M, M, HumHum ReprodReprod 20022002
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STERILITASTERILITA’’ DA FATTORE TUBARICODA FATTORE TUBARICO
La sterilitLa sterilitàà da fattore tuboda fattore tubo--peritoneale peritoneale (aderenze pelviche, occlusioni (aderenze pelviche, occlusioni tubarichetubaricheprossimali e distali, prossimali e distali, endometriosiendometriosi) ) rappresenta il fattore rappresenta il fattore eziologicoeziologico nel nel 40% dei casi di sterilit40% dei casi di sterilitàà femminilefemminile
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Fattore Tubo-Peritoneale di Sterilita’
Aderenze
Occlusione tubarica distale –Idrosalpinge
Occlusione tubarica prossimale
Endometriosi
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Aderenze
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ADERENZE POSTADERENZE POST--CHIRURGICHECHIRURGICHE
Le aderenze, causate da PID, Le aderenze, causate da PID, pregressi interventi, pregressi interventi, endometriosiendometriosi, , possono essere a loro volta causa di possono essere a loro volta causa di sterilitsterilitàà, dolore pelvico cronico, , dolore pelvico cronico, occlusione intestinale, gravidanza occlusione intestinale, gravidanza extraextra--uterina, reuterina, re--interventiinterventi
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COME SI FORMANO LE ADERENZE:Fenomeni a livello peritoneale (5-7 giorni)
Peritoneum
Peritoneal Defect
Increased Vessel Permeab
Inflammatory Exudate
Trauma
Fibrin Matrix
Fibrinolysis
Normal fibrinolytic activity Suppressed fibrinolytic activity
Plasminogen Ischemia
Resolution of fibrin
RepairMesothelium
Fibroblast Proliferation
Adhesion Formation
Persistence of fibrin
Organisation of fibrin matrix
PAPAI
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Classificazione delle Aderenze
• Incidenza • Estensione • Severità• Localizzazione
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Fertil Steril 1988
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Incidenza
• Aderenze De Novo
• Riformazione delle Aderenze
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Incidence of De Novo Adhesions
• 55% - 100% Incidence of Adhesions after Laparotomy
Time from Inital
Procedures
Total no. of
Patients
Total no. With
Adhesions
% with
Adhesions Diamomd et al DeCherney and Mezer
1 wk -12 wk 4 wk - 16wk 1 yr - 3 yr
106 20 41
91 15 31
86 75 76
Surrey and Friedman
6 wk – 8 wk > 6 mo
31 6
22 5
71 83
Pittaway et al Trimbos-Kemper et alDaniell and Pittaway
4 wk – 6 wk 8 days 4 wk – 6 wk
23 188 25
23 104 24
100 55 96
Adapted from Diamond MP, Surgical Aspects in Fertility. In Gynaecology and Obstetrics, 1988
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Adhesion Formation & Laparoscopy
Sites of adhesion formation following laparoscopy
Number of Patients
Reformed Adhesions
De Novo Adhesions
Diamond et al, 1991
62 67% tube 80% ovary
23% pelvic
Canis et al, 1992
42 82% adnexa 21% adnexa
Lundorff et al, 1991
31 60% tube 17% tube
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Aderenze Aderenze postpost--miomectomiamiomectomia laparoscopicalaparoscopica
Autore, annoAutore, anno n.pzn.pz 2Look (%)2Look (%) % aderenze% aderenze
Mais, 1996aMais, 1996a 2525 100%100% 40%40%
Mais, 1996bMais, 1996b 2525 100%100% 88%88%
BullettiBulletti, 1996, 1996 1616 88%88% 29%29%
DubuissonDubuisson, 1998, 1998 4545 100%100% 36%36%
TakeuchiTakeuchi, 2002, 2002 115 115 44%44% 29%29%
Di Gregorio, 2002Di Gregorio, 2002 635 635 19%19% 2%2%
MalzoniMalzoni, 2003, 2003 144144 12%12% 33%33%
TotalTotal 10051005 289 (29%)289 (29%) 25%25% ((4141%)%)
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...THE TWO ENDS OF THE SPECTRUM:...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)
• 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
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FUNCTIONAL CYSTS EXCISED AT OPERATIVE LAPAROSCOPY
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
Mettler, 2001 493 144 29
Benedetti Panici, 2002
282 12 4
Rasmussen, 1999 275 23 8
Marana, 2004 658 29 4
4495 1013 22.5%4495 1013 22.5%
Muzii and Benedetti Panici, JAAGL 2004
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LAPAROSCOPIC EXCISION OF FUNCTIONAL CYSTS
LAPAROSCOPIC EXCISION OF FUNCTIONAL CYSTS
•COST OF THE PROCEDURE
•ADHESIONS
•HARMFUL OF THE OVARY
•MEDICO-LEGAL IMPLICATIONS
•COST OF THE PROCEDURE
•ADHESIONS
•HARMFUL OF THE OVARY
•MEDICO-LEGAL IMPLICATIONS
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From Luciano AA et al, Fertil Steril, 1991From Luciano AA et al, Fertil Steril, 1991
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“...to avoid adhesionsyou must avoid surgery.”
L Mettler, Ann N Y Acad Sci, 2003
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ADERENZE POSTADERENZE POST--CHIRURGICHECHIRURGICHE
Le aderenze possono essere causa Le aderenze possono essere causa di di dolore pelvico cronicodolore pelvico cronico, sterilit, sterilitàà, , occlusione intestinale, gravidanza occlusione intestinale, gravidanza extraextra--uterina, reuterina, re--interventiinterventi
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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
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Laparoscopy for Chronic Pelvic Pain
0
10
20
30
40
50
60
70
80
no pathology adhesions endometriosis
Liston et alLundberg et alRenaerKresch et alRapkin
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Pain relief after laparoscopic adhesiolysis
No. of Pain Better Pain Not BetterStudy 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%)
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Pain & Adhesions Controversy
• Some patients have pelvic pain and no adhesions
• Some patients have adhesions and no pelvicpain
• After adhesiolysis, pain but later it couldreturn or
• No RCTs
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Adesiolisi?
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““The best single The best single sourcesource of of reliablereliable evidenceevidenceaboutabout the the effectseffects of of healthhealth carecare””
www.cochrane.orgwww.cochrane.org
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DJ Swank, Lancet 2003
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DJ Swank, Lancet 2003
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“This finding suggest that the value of laparoscopic adhesiolysisdoes not lie in the adhesiolysis itself.
Adhesions do not cause pain unless they are causing anobstruction.
Diagnostic laparoscopy could be of benefit to patients byrevealing other causes of their pain.
We recommend that clinicians consider abandoning laparoscopic adhesiolysis as a treatment”
DJ Swank, Lancet 2003
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L Demco, JAAGL 2004
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“Filmy adhesions between a moveable structure, such as anovary, and the peritoneum hadthe highest pain scores. Fixed or dense adhesions, no matterwhere they were located, hadthe lowest pain scores.” L Demco, JAAGL 2004
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Do not lyse the dense, fixed, difficult adhesions.
If in doubt, lyse only the easy adhesions
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ADERENZE POSTADERENZE POST--CHIRURGICHECHIRURGICHE
Le aderenze possono essere causa Le aderenze possono essere causa di dolore pelvico cronico, di dolore pelvico cronico, sterilitsterilitàà, , occlusione intestinale, gravidanza occlusione intestinale, gravidanza extraextra--uterina, reuterina, re--interventiinterventi
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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
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Adhesions & Infertility
• Impair fertility severely
• Surgical correction only partly effective…- Due to mucosal damage
- Due to adhesion reformation
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Infertility
0102030405060708090
100
12 24 36
Cumulative Pregnancy Rates of UntreatedTubal/Pelvic Damage vs Surgery
Perc
entC
oupl
es
Months
Normal
Grade I - Surgery
Grade II - Untreated
Grade I - Untreated
Grade II - Surgery
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Seppure in assenza di studi controllati Seppure in assenza di studi controllati randomizzatirandomizzati, l, l’’adesiolisiadesiolisi in caso di in caso di sterilitasterilita’’ ee’’ sicuramente indicatasicuramente indicata
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Occlusione tubaricadistale (DTO)
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OCCLUSIONE TUBARICA DISTALE
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Fertil Steril 1988
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SalpingoneostomiaSalpingoneostomia: creazione della : creazione della neostomianeostomia con elettrodo con elettrodo monopolaremonopolare o con laser a CO2 ad elevata densito con laser a CO2 ad elevata densitàà di potenza (spot di potenza (spot piccolo, potenza alta)piccolo, potenza alta)
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Eversione delle Eversione delle fimbriefimbrie; tale manovra viene eseguita in ; tale manovra viene eseguita in laparoscopia con il laser laparoscopia con il laser defocalizzatodefocalizzato o con il bipolare a o con il bipolare a bassa potenzabassa potenza
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Stabilizzazione della Stabilizzazione della neostomianeostomia con punti. In laparoscopia con punti. In laparoscopia tale procedura non tale procedura non èè necessarianecessaria
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SALPINGONEOSTOMIA: SALPINGONEOSTOMIA: CONFRONTO TRA LAPAROTOMIA CONFRONTO TRA LAPAROTOMIA E LAPAROSCOPIAE LAPAROSCOPIA
n. pazientin. pazienti % % gravgrav.. EPEPtotalitotali
LaparotomiaLaparotomia 10111011 34%34% 22--38%38%
LaparoscopiaLaparoscopia 370370 30%30% 00--18%18%
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…We recommend intraoperative salpingoscopy tovisualize the whole length of the ampullary lumen.
Whereas the status of the ampullary endosalpinx is alsoan important prognostic parameter, we elected not toinclude it in the scoring system at this time, sincesalpingoscopy is not being practiced universally…
The American Fertility Society, 1988
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SALPINGOSCOPY-classification of lesions-
Grade 1: normal fold patternGrade 2: separation and flattening of
foldsGrade3: focal lesion, e. g. small
adhesionsGrade 4: extensive adhesions and/or
disseminated flat areasGrade 5: complete loss of folds
Brosens, 1987
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GRADE 1-2
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GRADE 3
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GRADE 4
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GRADE 5
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CUMULATIVE TABLE OF PREGNANCIES
-According to the salpingoscopic grade
of the better tube-Salpingoscopic grade
I II III IV VSALPINGO-OVARIOLYSISNumber of patients 16 1 3 3 1
Intrauterine 11 1 0 0 0
Extrauterine 0 0 1 0 0SALPINGONEOSTOMYNumber of patients 10 1 2 11 3
Intrauterine 6 1 0 0 0
Extrauterine 0 0 0 2 0Marana 1999
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PERCENTAGE OF PATIENTS WITH
NORMAL TUBAL MUCOSA:
ADNEXAL ADHESIONS
Marana (1995) 76%
Brosens (1996) 80%
Expected intrauterine pregnancy rate: 70%
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PERCENTAGE OF PATIENTS WITH
NORMAL TUBAL MUCOSA:
HYDROSALPINGES
Marana (1995) 42%
Brosens (1996) 34%
Expected intrauterine pregnancy rate: 60%
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Occlusione tubaricaprossimale (PTO)
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Anastomosi Anastomosi tubotubo--tubaricatubarica (in caso di (in caso di ““reversalreversal””): apposizione ): apposizione di un punto sul di un punto sul mesosalpingemesosalpinge e del primo punto a ore 6e del primo punto a ore 6
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Completamento del primo strato con punti a ore 3, 9 e 12Completamento del primo strato con punti a ore 3, 9 e 12
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Louise Brown, born July 25, 1978
JP Toner, Fertil Steril 2002
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Al di Al di lala’’ di ogni discussione di tipo di ogni discussione di tipo etico, medico, economico, va etico, medico, economico, va salvaguardata la discussione sulle salvaguardata la discussione sulle INDICAZIONI !INDICAZIONI !
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DIAGNOSI ISTEROSALPINGOGRAFICA DIAGNOSI ISTEROSALPINGOGRAFICA PREOPERATORIA DI OCCLUSIONE PREOPERATORIA DI OCCLUSIONE TUBARICA: QUANTI FALSI POSITIVI TUBARICA: QUANTI FALSI POSITIVI RIVELATI POI ALLA CHIRURGIA?RIVELATI POI ALLA CHIRURGIA?
Occlusione prossimaleOcclusione prossimale 4141--61%61%
Occlusione distaleOcclusione distale 12%12%
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CONCLUSIONICONCLUSIONI•• Appropriata selezione delle Appropriata selezione delle pazienti e rpazienti e rispetto delle indicazioniispetto delle indicazioni
•• Conoscere i vantaggi ed i limiti della Conoscere i vantaggi ed i limiti della chirurgia della sterilitchirurgia della sterilitàà
•• Corretta informazione alla pazienteCorretta informazione alla paziente
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video
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Come prevenire le aderenze in corso di chirurgia annessiale?
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In letteratura In letteratura èè disponibile undisponibile un’’ampia ampia serie di dati, sia sperimentali che clinici, serie di dati, sia sperimentali che clinici, ma a tuttma a tutt’’oggi non esiste un metodo oggi non esiste un metodo universalmente accettato per la universalmente accettato per la prevenzione delle aderenzeprevenzione delle aderenze
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For laparoscopy, the perceivedpostoperative de novo adhesionformation rate was 0%-25%, whereas the adhesion reformationrate was 26%-75%; forlaparotomy, the rates were 26%-75% and >75%, respectively.
Muzii, JAAGL 2004Muzii, JAAGL 2004
Sixty-five percent of the respondents were using at least one method for postoperative adhesion prevention duringlaparoscopy, and 68% during laparotomy.The most frequentlyused 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 wereRinger's lactate (28%), normal saline (20%), and 4% icodextrin (20%). Antibiotic prophylaxis was used by 87.5% of respondents.
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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
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INTRAPERITONEAL RESIDENCE OF RINGER’S LACTATE: LONGER THAN EXPECTED
Results from a randomized, double-blind, clinical trial
Kurt Semm Award, AAGL 2003
PRELIMINARY STUDYESTIMATED IP VOLUME ESTIMATED IP VOLUME (mL) = =
--4x104x10--88 V V 44 + 4x10+ 4x10--55 V V 33 –– 1.32x101.32x10--22 VV22 + 2,45V + 3,4217+ 2,45V + 3,4217V = D1 x D2 x D3V = D1 x D2 x D3
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TIME (hrs) RINGER mL CONTROL mL P
0 289 (+ 38) 18 (+12) p<0.05
3 (+2)
7 (+3)
6 (+4)
24 185 (+72) p<0.05
48 55 (+28) p<0.05
96 18 (+6) N.S.
0 24
48
96
RESULTS
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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
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www.cochrane.orgwww.cochrane.org
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CochraneCochrane menstrualmenstrual disordersdisordersand and subfertilitysubfertility groupgroup
ReviewsReviews::•• BarrierBarrier agentsagents forfor preventingpreventingadhesionsadhesions after after surgerysurgery forfor subfertilitysubfertility•• LiquidLiquid and and fluidfluid agentsagents forforpreventingpreventing adhesionsadhesions after after surgerysurgery forforsubfertilitysubfertility
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AGENTI DI BARRIERAAGENTI DI BARRIERA
•• 15 15 RCTsRCTs
•• LPTM = 9, LPS = 6LPTM = 9, LPS = 6
•• Aderenze pelviche 6, Aderenze pelviche 6, MiomectomiaMiomectomia 5, Chirurgia 5, Chirurgia ovaricaovarica 4, 4, EndometriosiEndometriosi 2, Indicazioni varie 12, Indicazioni varie 1
•• 13 studi: 13 studi: InterceedInterceed vs. controllo, 2 studi: vs. controllo, 2 studi: InterceedInterceed vs. vs. GoreGore--TexTex, 1 studio: , 1 studio: GoreGore--TexTex vs. controllo, 1 studio: vs. controllo, 1 studio: SeprafilmSeprafilm vs. controllovs. controllo
•• In nessuno studio sono state valutate Gravidanze e In nessuno studio sono state valutate Gravidanze e Riduzione del dolore Riduzione del dolore
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AGENTI DI BARRIERAAGENTI DI BARRIERA
•• LL’’uso delluso dell’’InterceedInterceed ee’’ associato ad una minore incidenza associato ad una minore incidenza di formazione di aderenze (sia ridi formazione di aderenze (sia ri--formazione che formazione che formazione formazione de novode novo) dopo ) dopo chirugiachirugia laparoscopicalaparoscopica e e laparotomicalaparotomica
•• Il Il GoreGore--TexTex ee’’ piupiu’’ efficace di nessun trattamento o di efficace di nessun trattamento o di InterceedInterceed
•• Evidenze limitate sullEvidenze limitate sull’’efficacia del efficacia del SeprafilmSeprafilm per la per la prevenzione di aderenze dopo prevenzione di aderenze dopo miomectomiamiomectomia
•• InterceedInterceed efficace nel ridurre le aderenze, ma dati efficace nel ridurre le aderenze, ma dati insufficienti per raccomandarne linsufficienti per raccomandarne l’’uso per migliorare le uso per migliorare le percentuali di gravidanzapercentuali di gravidanza
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AGENTI LIQUIDI / FLUIDIAGENTI LIQUIDI / FLUIDI
•• Nessuno degli agenti liquidi o fluidi studiati ha Nessuno degli agenti liquidi o fluidi studiati ha determinato un aumento delle percentuali di gravidanza. determinato un aumento delle percentuali di gravidanza.
•• Alcune evidenze sullAlcune evidenze sull’’efficacia degli steroidi nel ridurre efficacia degli steroidi nel ridurre ll’’incidenza e la incidenza e la severitaseverita’’ della formazione di aderenze. della formazione di aderenze. DestranoDestrano inefficace.inefficace.
•• LL’’uso di routine di questi agenti non uso di routine di questi agenti non puopuo’’ essere essere raccomandato sulla base delle evidenze disponibili.raccomandato sulla base delle evidenze disponibili.
•• LL’’evidenza sugli steroidi eevidenza sugli steroidi e’’ ben lontana dallben lontana dall’’essere essere perfetta, ma suggerisce lperfetta, ma suggerisce l’’efficacia. Dovrebbero essere efficacia. Dovrebbero essere condotti studi addizionali.condotti studi addizionali.
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Intergel
Adept
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DB DB JohnsJohns, , FertilFertil SterilSteril 20012001
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“You shouldimmediatelydiscontinue useof the device”
March 2003
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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 followinglaparoscopic 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 MedicalGroup, San Diego Fertility Center, Private Practice, Memphis TN, and ML Laboratories PLC, Leicester, UK.
DiZerega, 2002
P = n.s.
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CONCLUSIONI CONCLUSIONI -- AderenzeAderenzeNonostante lNonostante l’’enorme mole di dati presenti in enorme mole di dati presenti in letteratura, non esiste oggi un approccio letteratura, non esiste oggi un approccio universalmente accettato. Luniversalmente accettato. L’’InterceedInterceed èè il il metodo sul quale oggi esistono pimetodo sul quale oggi esistono piùù studi. Nuovi studi. Nuovi metodi di barriera in studio. Lmetodi di barriera in studio. L’’approccio approccio laparoscopicolaparoscopico, probabilmente, determina una , probabilmente, determina una riduzione delle aderenze riduzione delle aderenze ““de novode novo””. La . La riformazione delle aderenze dopo riformazione delle aderenze dopo adesiolisiadesiolisisembra invece essere la norma pisembra invece essere la norma piùù che che ll’’eccezione, anche in laparoscopia.eccezione, anche in laparoscopia.
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CONCLUSIONICONCLUSIONILa corretta indicazione allLa corretta indicazione all’’intervento chirurgico intervento chirurgico èè probabilmente il mezzo piprobabilmente il mezzo piùù efficace per efficace per prevenire le aderenze postoperatorie.prevenire le aderenze postoperatorie.
LL’’accurata selezione delle pazienti e il rispetto accurata selezione delle pazienti e il rispetto delle indicazioni sono i puntidelle indicazioni sono i punti--chiave per ottenere chiave per ottenere i migliori risultati in chirurgia i migliori risultati in chirurgia laparoscopicalaparoscopica del del fattore tubofattore tubo--peritoneale di sterilitperitoneale di sterilitàà
LL’’utilizzo di tecniche chirurgiche nel rispetto dei utilizzo di tecniche chirurgiche nel rispetto dei tessuti tessuti èè ll’’altro punto fondamentale.altro punto fondamentale.
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Grazie per lGrazie per l’’attenzione!attenzione!