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Department of Clinical Epidemiology University of Santo Tomas Faculty of Medicine and Surgery

Department of Clinical Epidemiology University of Santo Tomas Faculty of Medicine and Surgery Case 6: Ectopic Pregnancy Lazaro, D. to Lim, Patrick Group 1 – 3C. Clinical Decision on a DIAGNOSTIC TEST. Case Scenario.

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Department of Clinical Epidemiology University of Santo Tomas Faculty of Medicine and Surgery

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  1. Department of Clinical Epidemiology University of Santo Tomas Faculty of Medicine and Surgery Case 6: Ectopic Pregnancy Lazaro, D. to Lim, Patrick Group 1 – 3C

  2. Clinical Decision on a DIAGNOSTIC TEST

  3. Case Scenario A.T. 25 yo female G3P1 (1-0-1-1) admitted because of vaginal spotting. She has a positive pregnancy test a week ago and a menstrual delay of 15 days. Last July 2006, she had the same complaint and passage of grape like tissue for which D & C was done. PPE: RR=30/min, mild tenderness at right iliac & hypogastrium; Cervix is soft and slightly tender, bluish with brownish discharge from the os. There is mild tenderness of the slightly enlarged uterus and of the right adnexa area.

  4. Salient Features 25-year old, female, G3P1 (1-0-1-1) Vaginal spotting (+) Pregnancy test Menstrual delay of 15 days RR = 30/min Mild tenderness at the right iliac & hypogastrium Cervix: soft and slightly tender, bluish with brownish discharge from os Mild tenderness of the slightly enlarge uterus and of the right adnexa area.

  5. Differential Diagnosis Molar Pregnancy Trophoblastic disease – persistent trophoblast Normal Pregnancy Salpingitis Corpus luteum cysts Adnexal torsion Appendicitis

  6. Table 1. Symptoms of Ectopic Pregnancy From Weckstein, LN: Current perspective on ectopic pregnancy. Obstet Gynecol Surv 40:259, 1985.

  7. Table 2. Signs of Ectopic Pregnancy From Weckstein, LN: Current perspective on ectopic pregnancy. Obstet Gynecol Surv 40:259, 1985.

  8. Clinical Question What is the most accurate diagnostic tool in a reproductive age female presenting with signs & symptoms of ectopic pregnancy?

  9. Search Terms: Reproductive age female, diagnostic procedure, ectopic pregnancy Limits: Added to PubMed in the last 10 years, Published in the last 10 years, Humans, Female, All Adult: 19+ years Population: Reproductive female, positive pregnancy test, menstrual delay Intervention: Diagnostic test Outcome: Accuracy

  10. Search Strategies

  11. Articles Found and Appraised George Condous, Emeka Okaro, Asma Khalid, Chuan Lu, Sabine Van Huffel, D Timmerman, Tom Bourne.The accuracy of transvaginal ultrasonography for the diagnosis of ectopic pregnancy. Human Reproduciton Vol. 20, No.5 pp. 1404 – 1409, 2005. Jun Y, Naobumi Y, Takahiro K, Toshihiro O, Hajime K. (2006). Diagnosis of ectopic pregnancy with MRI: efficacy of T2*-weighted imaging. Magnetic Resonance in Medical Sciences, Vol. 5, No.1, pp. 25-32 Refaat Bassem, Amer Saad, Ola Bolarinde, Chapman Neil, Ledger William. The expression of Activin-βA and –βB-Subunits, Follistatin, and Activin Type II Receptors in Fallopian Tubes Bearing an Ectopic Pregnancy. The Journal of Clinical Endocrinology Metabolism Vol 93, No. pp. 293-299, 2008 Pasquale Florio, Filiberto Maria Severi, caterina Bocchi, Stefano Luisi, Massimo Mazzini, Secondo Danero, Michela Torricelli, Felice Petraglia. Single Serum Activin A Testing to Predict Ectopic Pregnancy. The Journal of Clinical Epidemiology and Metabolism Vol 92, No.5 pp. 1748 – 1753, 2007. Evidence Based Medicine: DIAGNOSIS

  12. Spectrum of Disease: Ectopic Pregnancy 65% 80% 20%

  13. Critical Appraisal Evidence Based Medicine: DIAGNOSIS

  14. Critical Appraisal

  15. Sensitivity Analysis Total Number of Patients: 6621 TVS Pregnancy of Unknown Location (PUL): 581 Intrauterine Pregnancy (IUP): 5840 Ectopic Pregnancy (EP)*: 200 FN TN Surgically managed: 152 Conservative management: 48 TP FP (-): 9 (+): 143 *Fulfilled criteria set by the study for diagnosis of EP on TVS

  16. Sensitivity Analysis • Best Case Scenario • If the 48 patients managed conservatively were considered to have positive results on gold standard, then TP = 143 + 48 = 191 • Worst Case Scenario • If the 48 patients managed conservatively were considered to have negative results on gold standard, then FP = 9 + 48 = 57

  17. Gold standard: Laparoscopy TVS Specificity: 100% Sensitivity: 25% LR (-): 0.75 LR (+): 160.79 PTP (-): 58% PTP: (+): 100%

  18. Gold standard: Laparoscopy TVS Specificity: 99% Sensitivity: 20% LR (-): 0.81 LR (+): 20.3 PTP (-): 60% PTP (+): 97%

  19. Evidence Based Medicine: DIAGNOSIS

  20. Spectrum of Disease: Ectopic Pregnancy 65% 99 - 100% 58- 60% 80% 20% TVS Post-test Probability Lower/Upper Testing Threshold Pretest Probability

  21. Comment Transvaginal ultrasound, when positive, can be diagnostic for ectopic pregnancy in reproductive age group females presenting with signs and symptoms of vaginal spotting, delayed menstruation, positive pregnancy test, and tenderness at right iliac and hypogastric area. However, a negative result would need further diagnostic work-ups. Evidence Based Medicine: DIAGNOSIS

  22. THERAPY 25

  23. Clinical Scenario 26

  24. Articles Found and Appraised A RANDOMIZED CONTROLED COMPARISON OF MINILAPAROTOMY AND LAPAROTOMY IN ECTOPIC PREGNANCY CASES 27

  25. Journal Title:A RANDOMIZED CONTROLED COMPARISON OF MINILAPAROTOMY AND LAPAROTOMY IN ECTOPIC PREGNANCY CASES J B SHARMA, S GUPTA, M MALHATORA, R ARORA ;Indian Journal of Medical Science Vol 57 No 11 November 2003 28

  26. Relevance • The study aimed to compare the efficacy and safety of minilaparotomy surgery for ectopic pregnancy cases with standard laparotomy method. • Population – women in reproductive age (19-40 yrs. Old) with suspected ectopic pregnancy • Intervention – Surgery: Minilaparotomy • Outcome – safety and less complications • Methodology – Randomized Control trial (computer generated numbers) 29

  27. VALIDITY:Was the assignment of patients to treatment randomized? • The assignment of patients to treatment was randomized using computer generated numbers. • This is seen in the TITLE, ABSTRACT and METHODOLOGY 30

  28. Were all patients who entered the trial properly accounted for and attributed at its conclusion? • Yes. All patients (60 cases) were accounted for. • In Tables 2 and 3 analysis, the sum of the patients totaled the number who were randomized at the start of the study. • Was Follow-up complete? • Patients were discharged if there were no complications and were seen in the outpatient clinic after 2 weeks for any complications and to collect their histopathology report (Methodology) 31

  29. Patients were analyzed in the groups to which they were randomized. Conversion of surgical method was not done (Results) • No drop-outs and withdrawals. • 0 cases of readmissions and repeat laparotomy 32

  30. Were the patients analyzed in the groups to which they are randomized? • Yes, there was no crossing over in the study groups • Were the patients, health workers and study personnel blind to treatment? • No blinding - surgical in nature • Blinding was not mentioned in the paper • Were the groups similar at the start of the treatment? • - Yes. Table 1 of the results section showed no significant difference in the baseline characteristics between the two groups. 33

  31. RESULTS 09/04/09

  32. Complication rates (Table 3) 35

  33. Paralytic ileus Urinary retention 09/04/09

  34. Fever UTI 09/04/09

  35. Wound Infection Malaria – dko lam if ksama pa tong malaria na ito! 09/04/09

  36. RESULTS: total complications p value = 0.05 Confidence interval = 95% 39

  37. Table 2. See results on operating time Table 3. See results on Hospital stay Pain relief Other endpoints measured Table 2. 09/04/09

  38. CARING FOR MY PATIENT:Can the results be applied to my patient care? • Inclusion criteria • reproductive aged women w/ mean age of the Tx Group at 25 yrs. old • Ectopic pregnancy • Exclusion criteria • Patients w/ significant medical dse like diabetes, hypertension and previous laparotomy 41

  39. Were all clinically important outcomes considered? Outcome, results • 0 reported deaths • 0 readmission • 0 repeat laparotomy • The main outcomes considered were the development of complications • Paralytic ileus, urinary retention, fever, UTI, wound infection, malaria 42

  40. Bottomline • Conclusion • Surgery by minilaparotomy technique in ectopic pregnancy cases appears to be a safe and feasible method and is superior to conventional laparotomy as there are minimum postoperative complications and patients can be discharged early w/o the need of expensive equipment. • There is also less estimated blood loss, operating time, hospital day stay , pain relief injections needed. 43

  41. Clinical Decision on HARM

  42. Clinical Question What are the complications of performing surgical treatment (salpingectomy) in women with ectopic pregnancy?

  43. Population: women with ectopic pregnancy Intervention: salpingectomy Outcome: risks, harm, complications Method: cohort Search Terms: ectopic pregnancy, laparoscopy, laparotomy complications Limits: full text article, within the last 10 years

  44. Articles Appraised Chan, C.C.W., Ng, E.H.Y., Li, C.F. and Ho, P.C., Impaired Ovarian Blood Flow and Reduced Antral Follicle Count following Laparoscopic Salpingectomy for Ectopic Pregnancy, Human Reproduction, 2003. • Zhu L., Wong, F., Bai J., Operative Laparotomy vs Laparoscopy for the Management of Ectopic Pregnancy, Chinese Medical Journal, 2000.

  45. Relevance

  46. Validity

  47. Validity

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