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FSA SYMPOSIUM ON REPRODUCTIVE SURGERYFSA SYMPOSIUM ON REPRODUCTIVE SURGERYSTOP: NON INCISIONAL FEMALE STERILISATION UNDER MINIMAL SEDATION(FALLOPOSCOPY: DIAGNOSTICALLY USEFUL BUT TECHNICALLY CHALLENGING)Kerin John*,Plummer Helen, University ofAdelaide and STOP ResearchCentre,Ashford Medical CentreAdelaide S.A. AustraliaIntroductionThe single biggest threat to Earth's animal and plant. survival is human overpopulation in the next 50 years. Worldwidethere are 200 million human pregnancies per year and 13 million female sterilisations carried out byincisional surgery under general anaesthesia (WHO, 1998). However expensive and complex, sterilisation procedures aremostly unavailable to women who most need it in developing countries. Previous hysteroscopic methods failed to meetsafety and efficiency expectations (Kerin, Int. 1. Gynaecol. & Obstet. 51,29-39,1995).Materials and MethodsThe STOP system, developed by Conceptus Inc., San Carlos, California, USA, delivers a proprietary micro-coil device tothe tubal lumen using a small hysteroscope and refined tubal access technology. Upon release, the outer coil ofthe deviceexpands to gently wedge itselfagainst the individual tube's lumen and configuration across the utero-tubal junction. Thedevice is made ofinert materials and is theorized to have a permanent contraceptive effect due to its space filling design thatincites a local benign tissue reaction, which altersthe function and architecture ofthe tube (Valle & Cooper etal, AAGL, Nov 1999). The patient can observe the 10 to 15minute procedure on a video monitor and return home after a brief observation period. This world first Phase II ClinicalStudy began in July 1997 following approval by TQEH and Ashford Research and Ethics Committees and complies withthe US Food and Drug Administration (FDA) guidelines.ResultsPresently 87 women are happily wearing STOP devices. A hysterosalpingogram (HSG) 3 months post insertion showsbilateral proximal tubal occlusion in all cases. There has been no apparent change in menstrual cycle pattern, abnormalbleeding,pain or coital discomfort. No pregnancies have occurred to date. In 6 women,unsuspected proximal tubal stenosis or obstruction prevented placement. In 2 women asymptomatic tubal perforationoccurred and was detected at the 3 month HSG where tubal occlusion was also demonstrated. These devices were easilyremoved at subsequent clip sterilization. There were 3 technical failures and 2cases ofunilateral migration ofthe devices further along the tube detected at HSG again with tubal occlusion demonstrated.ConclusionTo .date th~ Pha~e II study data deJ?onstrates promising clinical outcomes in terms ofpregnancy prevention and very highpatlent satisfactiOn levels. Recent lmprovements in device design have markedly reduced technical difficulties andimproved stability in the tube. To date there have been no serious adverse outcomes.SELECTIVE SALPINGOGRAPHY, TUBAL CATHERISATION AND TRANSCERVICALTUBAL RE-CANALISATIONRobert WoolcottLingard Fertility Centre, Newcastle, New South Wales, 2291Selective salpingography remains a specialised investigation confined to tertiary referral institutions. This is largely due tothe perceived technical difficulty oftrans-cervical approach to the Fallopian tube associated with the inability to guide thecannula to the internal tubal ostia and the lack offamiliarity with fluoroscopic image intensification equipment Thetechnique is simple, easy to learn and inexpensive. There are implements available however such as the Fallopotorque tubalcatheterisation set which make it simple for almost every clinician with an average knowledge ofuterine anatomy andtechnical skill to perform this procedure. Most clinicians with hospital appointments have access to the necessaryfluoroscopic equipment to perform the procedure. Equipment and performance costs are only a fraction ofthat associatedwith laparoscopic or microsurgical procedures. Selective salpingography is superior to laparoscopic dye studies as a test ofFallopian tube patency.A randomised prospective controlled study oflaparoscopic dye studies versus selective salpingography as diagnostic tests offallopian tube patency, involving 278 female patients undergoing investigation ofinfertility, demonstrated selectivesalpingography to be a superior test ofFallopian tube patency. In 16/135 (11.9%) laparoscopies diagnosed proximal tubalocclusion (PTa) versus 5/138 (3.6%) at selective salpingography (p=0.018). Furthermore, when apparent bilateral proximaltubal occlusion is present as determined by both laparoscopic dye studies and hysterosalpingogram (in combination),selective salpingography will enable the demonstration ofpatency in approximately 35% oftubes.There is a potential therapeutic effect ofselective salpingography alone and the use ofthe technique permits immediatetreatment ofproximal tubal occlusion. Selective salpingography involving tubal catheterisation with or without wire guidecannulation is deemed by the American Society ofReproductive Medicine to be the management ofchoice where PTO ispresent alone without distal tubal disease. (American Fertility Society. 1993). There appears to be a significant therapeuticeffect ofselective salpingography alone, which is consistent with apparent benefit ofHSG on pregnancy rates. There isadifferential impact ofselective salpingography, tubal catheterisation and wire guide re-canalisation on pregnancy rates whenthese procedures are performed sequentially on a single occasion for the diagnosis and treatment ofapparent PTa. Crudepregnancy rates of20% for selective salpingography, 39% for tubal catheterisation and 13% for wire guide re-canalisationhave been achieved.Falloposcopy is a logical investigative extension ofabnormalities discovered by selective salpingography. Shouldmicrosurgical resection and re-anastomosis be contemplated due to an inability to achieve patency via trans-cervicalmethods then trans-fimbrial salpingoscopy is a wiser method ofendosalpingeal assessment. Apparent proximal tubalocclusion as diagnosed by selective salpingography identifies a sub-group ofpatient at high rsik ofhaving endometriosis.The association between endometriosis and PTa needs further investigation. Endometriosis is present in approximately70% ofpatients with proximal occlusion and otherwise normal tubes and PTa is present in 5-10% ofwomen withendometriosis.Selective Salpingography should be considered the 'gold standard' testofFallopian Tube patency. It has bothdiagnostic and therapeutic advantages over other methods and as such should be adopted more widely into routine clinicalpractice by general gynaecologists and infertility specialists alike.134135