via and vili form for cervical screening
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Appendix 1
FIGO staging of cervical carcinomas
Stage ISt age I is carcinoma st r ict ly confined t o the cervix; extension to t he uter ine corpus should
be di sregarded. The di agnosis of bot h St ages IA1 and IA2 should b e based on mi croscopicexamination of removed t issue, preferably a cone, which must include the enti re lesion.Stage IA: Invasive cancer identif ied only microscopically. Invasion is l im it ed to measured
stromal invasion wi th a maximum depth o f 5 mm and no wider than7 mm.
Stage IA1: Measured invasion of t he st roma no greater t han 3 mm i n dept h and no widerthan 7 mm diameter.
Stage IA2: Measured invasion of stroma greater than 3 mm but no greater than 5 mm indepth and no wider than 7 mm in diameter.
Stage IB: Clinical l esions confined t o t he cervix or precl in ical l esions greater t han St ageIA. All gross lesions even wit h superf icial invasion ar e St age IB cancers.
Stage IB1: Clinical lesions no greater than 4 cm in size.Stage IB2: Clinical lesions greater than 4 cm in size.
Stage IISt age II is carcinoma that extends beyond t he cervix, but does not ext end into t he pelvicwal l . The carcinoma involves the vagina, but not as far as the lower th ird.Stage IIA: No obvious parametr ia l involvement. Involvement of up to the upper two-
thirds of the vagina.Stage IIB: Obv ious pa ramet r i a l i nvo l vemen t , bu t no t i n to t he pe lv i c sidewa l l .
Stage IIISt age II I is carcinoma t hat has extended int o t he pelvic sidewal l . On rect al examinati on,there is no cancer-free space between the tumour and the pelvic sidewal l . The tumourinvolves t he lower t h ird of t he vagina. Al l cases wit h hydronephrosis or a non-funct ioningkidney are St age III cancers.Stage IIIA: No extension in to t he pe lv ic sidewal l bu t involvement o f the low er t h i rd o f t he
vagina.Stage IIIB: Ext ension int o t he pelvic sidewal l or hydronephrosis or non-funct ioning kidney.
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Stage IVSt age IV is carcinoma t hat has extended beyond t he t rue pelvis or has cl in ical ly involved
the mucosa o f the b ladder and/ or rectum.Stage IVA: Spread of the tumour into adjacent pelvic organs.Stage IVB: Spread to distant organs.
Source: TNM Classif icat ion of mali gnant t umours. L. Sobin and Ch Witt ekind (eds.),UICC Inter nati on Union against Cancer, Geneva, Swi t zerland, pp155-157; 6t h ed. 2002.
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The doctor/ heal th worker explained to m e in detai l about t he vinegar (VIA)/ iodine (VILI)test(s)* for t he ear ly det ection and prevention of cancer in the neck of m y womb (ut er ine
cervix) . I understand that the surface of my cervix wi l l be visual ly inspected afterapp l i cat i on o f 5% acet i c ac id / d i l u te i od ine so lu t i on t o de tec t o r t o exc ludeprecancer/ cancer. I underst and that t hese procedures are generally harm less, but mayoccasionally cause some irritation or mild bleeding, which can be easily controlled.
I underst and that, i f t he test is posi t ive, ot her t est s such as magnif i ed inspection of thecervix wit h an inst rument cal led a colposcope and examinat ion of a sample of t he t issuein my cervix (biopsy) may be recommended before treatment is provided. I have beeninformed t hat t reatm ent by medicines or cryotherapy (dest roying the diseased port ion ofthe cervix by an ice-cold met al probe) or rem oving the diseased port ion by mi nor surgeryor major surgery and/ or tr eatment wit h x-rays, m ay be required, in t he event of anyabnormal i t y ( infect ion or precancer or cancer or compl icat ions) being detected.
I hereby express my wil l ingness to undergo the above tests and treatment, i f advised.*/ I am no t w i l l ing t o un de rgo t he abov e proc ed ur es. *
Signature:
Date:
Name:
Address:
* Delete as appropriate
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Appendix 2
INFORMED CONSENT
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1. Cl in ic/ Ser ial / Unique number ______________
2. Dat e of t est ing [ ] [ ] - [ ] [ ] - [ ] [ ](day (2 digits)-mont h (2 digit s)-year (2 digit s)):
3. Name: ______________________________________________________________
4. Address: ________________________________________________________________________________________________________________________________
5. Age (in years) [ ] [ ]
6 . Educat ion (1 : Ni l ; 2 : Pr imary; 3 : Midd le ;4: High school ; 5: Col lege; 9: Not know n) [ ]
7 . When d id you have your last menstruat ion?(1: Less t han 12 mont hs ago; 2: More t han 12 mont hs ago) [ ]
8. Mari ta l st atus: (1: Marr ied; 2: Widowed; 3: Separated;8: Ot her ; 9: Not know n) [ ]
9 . Age a t marr iage or f i rst sexua l in tercourse: (99, i f not known) [ ] [ ]
10. Tot al num ber of pregnancies/ m iscar r iages: [ ] [ ]
11. Do you suff er from t he fol lowing?(use to indicate if the response is yes; otherwise, leave blank): Excessive vaginal discharge Itching in the external anogenitalia Ulcers in the external anogenitalia Lower abdominal pain Pain during sexual intercourse
Appendix 3
Format for reporting results of VIA and VILI
Screening with VIA and VILI
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Bleeding after intercourse Intermenstrual bleeding
Low back ache
12. Visual examination f indings(use to indicate if the response is Yes, otherwise, leave blank): Squamocolumnar junction fully seen Cervical polyp Nabothian foll icles Cervicitis Leukoplakia Condyloma Growth
13. Findings one minut e aft er applicat ion of 5% acetic acid (VIA)(1: Negat ive; 2: Posi t ive; 3: Posi t ive, invasive cancer) [ ]
14. If VIA posi t ive, does the acetowhit e lesion extend into t he endocervical canal?(1: Yes; 2: No) [ ]
15. If VIA posi t ive, how m any quadrants are involved in t he acet owhite lesion(s)?(1: Tw o or less; 2: Three; 3: Four quadrant s) [ ]
16. Diagram(Draw t he locat ion of t he squamocolumnar j unction wit h a dott ed l ine and theacetow hit e/ iodine non-uptake area(s) as a cont inuous l ine)
VIA VILI
17. Findings aft er applicat ion of Lugols iodine (VILI)(1: Negative; 2: Posit ive; 3: Posit ive, invasive cancer) [ ]
18. If invasive cancer, st age (1: IA; 2: IB; 3: IIA; 4: IIB;5: IIIA; 6: IIIB; 7: IVA; 8: IVB; 9: Not know n) [ ]
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19. Biopsy t aken? (1: Yes; 2: No)(If yes, indicate t he biopsy si t e(s) in the diagram wit h x mark) [ ]
20. Act ion taken: (1: Advised fol low-up aft er f ive years;2: Advised medication for cervicitis and follow-up after six months;3: Referred f or colposcopy; 4: Referred for immediate tr eatment ;5: Referred for staging and treatment of invasive cancer;6: Ot her, speci f y _________________________) [ ]
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Appendix 4
Cleaning and sterilization of instruments andmaterials used for early detection and
treatment of cervical neoplasia:
Instrument/material
Vaginal speculum, vaginal
retr actors, biopsy forceps,
toothed forceps, r ing
forceps, Cheatles forceps.
Gloves.
Examination t able, halogen
lamp, torch l ights,
instr ument t rol ley, t rays.
HLD: High-level d isinfection
Processing
Decontamination and
cleaning fol lowed by
steril ization or HLD.
Decontamination and
cleaning fol lowed by
steri l izat ion.
Intermediate or low-level
disinfect ion.
Suggested procedure
Decontamination b y
immer sing in 0.5%chlorine
for 10 minutes fol lowed by
cleaning with water and
detergents; cleaned
instr uments may be
immer sed in boi l ing water
for 20 minut es (high-level
disinfect i on) or may be
steril ized using autoclave
before re-use.
Decontamination b y
immer sing in 0.5%chlorine
for 10 minutes fol lowed by
cleaning with water and
detergents; steri l ized using
an autoclave in wrapped
packs.
Wipe with 60-90%ethyl or
isopropyl alcohol or wit h
0.5%chlorine solut ion.
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Preparation of 0.5% chlorinesolution:
The general formula for making a di lutech lo r i ne so lu t i on f rom a commerc ia lpreparation of any given concentrat ion isas fol lows: Total parts of water = [%concentra te / % d i lu te ] -1 . For example , t omake a 0.5% di lut e solut ion of chlor inefr om 5% concent rat ed l iquid householdbleach = [ 5.0%/ 0.5%] -1 = 10-1 = 9 parts ofwater ; hence add one par t o f concentr a tedbleach to nine parts of water.
I f one is using commercial ly avai lable dry
powder chlor ine, use the fol low ing form ulato calculate the amount ( in grams) of drypowder required t o make 0.5% chlor inesolut ion:
Grams/ l i t re = [% di lut e/ % concentrat e] x1000. For example, t o make a 0. 5% di lut e
chlor ine solut i on from a dry pow der of 35%calcium hypochlor it e = [0.5%/ 35%] x 1000 =
14.2 g. Hence add 14.2 grams of drypowder to 1 l i t re o f w ater or 142 grams to10 l i tres of water. The instruments shouldnot be le f t in d i lu te b leach for more than10 minutes and should be cleaned in boiledwater immedia te ly a f ter decontaminat ionto prevent discolouration and corrosion ofme ta l .
Decontamination of the floor ofthe screening clinic:The f loor of t he screening cl in ic should be
decontaminated on a da i ly basis wi thchemica l d i s in fec tan ts i nc lud ingiodophores (e.g., 10% povidone iodine).
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5% dilute acetic acid
Ingredients Quantity1. Glacial acet ic acid 5 m l2. Dist i l led w at er 95 m l
PreparationCareful ly add 5 ml of g lacial acetic acid int o 95 ml of d ist i l led w ater and mi x t horoughly.
Storage: Unused acetic acid should be discarded at the end of the day.
Label: 5% dilu t e aceti c acid
Note: It is import ant to r emember to dilut e the glacial acetic acid, since the undiluted
strength causes a severe chemical burn if applied to the epithelium.
Lugols iodine solution
Ingredients Quantity1. Pot assium iodide 10 g2. Dist i l led w at er 100 m l3. Iodine cryst al s 5 g
PreparationA. Dissolve 10 g potassium iodide in 100 ml of disti l led water.B. Slowly add 5 g iodine crystals, while shaking.C. Fi l ter and store in a t ightly stoppered brown bott le.
Storage: 1 month
Label: Lugols iodine solution; Use by (date)
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Appendix 5
Preparation of 5% acetic acid,Lugols iodine solution, and Monsels paste
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Monsels paste
Ingredients Quantity1. Fer r ic sul f at e base 15 g2. Fer rous sul f at e pow der a f ew grains3. St er i l e w at er f or m ixing 10 m l4. Gl ycer ol st ar ch (see prepar at ion bel ow ) 12 g
PreparationTake care: The reaction is exothermic (emits heat).
A. Add a f ew grains of ferr ous sul fat e powder t o 10 ml of st er i le w ater in a glass beaker.Shake.
B. Dissolve t he f err ic sul fat e base in t he solut ion by st i r r ing w it h a glass st ick. Thesolution should become crystal clear.
C. Weigh the glycerol starch in a glass mortar. Mix well.D. Slowl y add fer r ic sul fat e solut i on t o glycerol st arch, constantl y mixi ng to get a
homogeneous mixt ure.E. Place in a 25 ml brown glass bottle.F. For cl i n ical use, m ost cl in ics prefer t o al low enough evaporation t o give the solut ion a
sticky paste- l ike consistency that looks l ike mustard. This may take 2 to 3 weeks,depending on the environment. The top of the container can then be secured forstorage. I f necessary, ster i le water can be added to the paste to th in i t .
Note: This preparation cont ains 15% element ary i ron.
Storage: 6 months
Label: Monsels solution; Shake well; External use only; Use by (date)
Glycerol starch (an ingredient in Monsels paste)
Ingredients Quantity1. St arch 30 g2. St er i l e w at er f or m ixing 30 m l3. Glycer ine 390 g
PreparationA. In a china crucible, d issolve t he st arch in t he st er i le w ater.B. Add the glycerine. Shake well.C. Heat t he crucible and i t s content s over a bunsen burner. Mix const antly wit h a spatula
unti l the mass takes on a thick, swell ing consistency. Take care not to overheat so asnot to le t i t tu rn ye l low.
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Storage: 1 year
Label: Glycerol st arch; St ore in a cool p lace; For ext ernal use only; Use by (dat e)
Note: Do not overheat, otherwise the mixture will turn yellow.
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Ott aviano, M. & La Torr e, P. ( 1982)Examinat ion o f the cerv ix wi th the
naked eye using acetic acid t est . Am. J.Obstet. Gynecol. , 143 , 139-142.
Cecchini , S., Bonardi , R., Mazzotta, A.,Grazzini, G. , Iossa A. & Ciat t o, S. ( 1993)Te st i n g c e r vi c og r ap h y an d VIA a sscreen ing tests for cerv ica l cancer .Tumori, 79, 22-25.
stor , A .G. (1993) Natura l h is tory o fce rv i ca l i n t raep i the l i a l neop las ia : acr i t ical review. Int. J. Gynecol. Pathol. ,12, 186-192.
Sankaranarayanan,R., Wesley, R.,
Somanathan, T. , Dhakad, N. ,Shyamalakumary, B., Sreedevi Amma,N., Parkin, D.M. & Krishnan Nair, M.(1998) Performance of visual inspectionaft er acetic acid appl ication (VIA) in thedet ection of cervical cancer precursors.Cancer, 83, 2150-2156.
Walboomers, J.M.M., Jacobs, M.V., Manos,M.M., Bosch, F.X., Kumm er, J.A. , Shah,K.V., Snij ders, P.J. , Peto, J., Meijer,C.J. & Munoz, N. (1999) Humanpapil lomavirus is a necessary cause ofinvasive cervical cancer worldwide. J.Pat hol. , 189 , 12-19.
Sankaranarayanan, R., Shyamalakumary,B., Wesley, R., Sreedevi Amma, N.,Parkin, D.M. & Krishnan Nair, M. (1999)Visual inspection with acetic acid in the
early detection of cervical cancer andprecursors. Int. J. Cancer, 80, 161-163.
Universit y of Zimbabw e/ JHPIEGO Cervic alCancer Project (1999) Visual inspectionwi th acet ic ac id for cerv ica l -cancerscreening: test qual i t ies in a pr imary-care sett ing. Lancet, 353 , 869-873.
Denny, L . , Kuhn, L . , Po l lack, A. ,Wainwright , H. & Wright, T.C., Jr (2000)Evaluation of al ternative methods ofcervical cancer screening for resource-poor settings. Cancer, 89, 826-833.
Bel inson, J.L., Pretor ius, R.G., Zhang,W. H., Wu, L. Y. , Qiao, Y. L. & Elson, P.
(2001) Cervical cancer screening bysimple visual inspection after aceticacid. Obst et . Gynecol. , 98, 441-444
Sankaranarayanan, R., Budukh, A.M. &Rajkumar, R. (2001) Effective screeningprogrammes for cervical cancer in low-and midd le - i ncome deve lop ingcountr ies. Bull. World Health Org. , 79,954-962.
Goldie, S.J., Kuhn, L., Denny, L., Pollack,A. & Wright, T.C. (2001) Policy analysisof cervical cancer screening strategiesin low-resource set t ings: c l in ica lbenefi ts and cost-effect iveness. JAMA,285 , 3107-3115.
Denny, L., Kuhn, L., Pol lack, A. & Wright,T.C., Jr (2002) Direct visual inspectionfor cerv ica l cancer screen ing: an
Suggestions for further reading
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analys is o f factors in f luencing testperformance. Cancer, 94, 1699-1707.
Mandelb la t t , J . S. , Lawrence, W.F. ,Ga f f i k i n , L . , L impahayom, K .K . ,Lumbiganon, P., Warakam in, S., King,J., Yi, B., Ringers, P. & Blument hal, P.D.(2002) Costs and benefits of differentstrategies to screen for cervical cancerin less-developed countr ies. J. Natl .Cancer Inst . , 94, 1469-1483.
Ferenczy, A. & Franco, E. (2002) Persist enthuman pap i l l omav i rus i n fec t i on andcervical neoplasia. Lancet Oncol. , 3,11-16.
Royal Thai College of Obstetricians andGynaecologists (RTCOG) and theJHPIEGO Corporation Cervical Cancer
Prevention Group (2003). Safety,acceptabi l i t y, and f easibi l i t y of a single-
v is i t approach to cerv ica l -cancerp reven t ion i n ru ra l Tha i l and : ademonstra t ion pro ject . Lancet, 361,814-820.
Sankaranarayanan, R., Wesley, R., Thara,S., Dhakad, N., Chandralekha, B.,Sebast ian, P., Chit hrat hara, K. , Parki n,D.M. & Krishnan Nair, M. (2003). Testcharacter ist ics of visual inspection with4% acetic acid (VIA) and Lugols iodine(VILI) in cervical cancer screening inKerala, India. Int. J. Cancer, 106,
404-408.
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Further reading
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