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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

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

Clinical Decision on a DIAGNOSTIC TEST


Case scenario

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.


Salient features

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.


Differential diagnosis

Differential Diagnosis

Molar Pregnancy

Trophoblastic disease – persistent trophoblast

Normal Pregnancy

Salpingitis

Corpus luteum cysts

Adnexal torsion

Appendicitis


Table 1 symptoms of ectopic pregnancy

Table 1. Symptoms of Ectopic Pregnancy

From Weckstein, LN: Current perspective on ectopic pregnancy. Obstet Gynecol Surv 40:259, 1985.


Table 2 signs of ectopic pregnancy

Table 2. Signs of Ectopic Pregnancy

From Weckstein, LN: Current perspective on ectopic pregnancy. Obstet Gynecol Surv 40:259, 1985.


Clinical question

Clinical Question

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


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

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


Search strategies

Search Strategies


Articles found and appraised

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


Spectrum of disease ectopic pregnancy

Spectrum of Disease: Ectopic Pregnancy

65%

80%

20%


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

Critical Appraisal

Evidence Based Medicine: DIAGNOSIS


Critical appraisal

Critical Appraisal


Sensitivity analysis

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


Sensitivity analysis1

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


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

Gold standard: Laparoscopy

TVS

Specificity: 100%

Sensitivity: 25%

LR (-): 0.75

LR (+): 160.79

PTP (-): 58%

PTP: (+): 100%


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

Gold standard: Laparoscopy

TVS

Specificity: 99%

Sensitivity: 20%

LR (-): 0.81

LR (+): 20.3

PTP (-): 60%

PTP (+): 97%


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

Evidence Based Medicine: DIAGNOSIS


Spectrum of disease ectopic pregnancy1

Spectrum of Disease: Ectopic Pregnancy

65%

99 - 100%

58- 60%

80%

20%

TVS Post-test Probability

Lower/Upper Testing Threshold

Pretest Probability


Comment

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


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

THERAPY

25


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

Clinical Scenario

26


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

Articles Found and Appraised

A RANDOMIZED CONTROLED COMPARISON OF MINILAPAROTOMY AND LAPAROTOMY IN ECTOPIC PREGNANCY CASES

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Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

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


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

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)

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Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

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

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Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

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)

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Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

  • 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

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Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

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.

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Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

RESULTS

09/04/09


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

  • Complication rates (Table 3)

35


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

Paralytic ileus

Urinary retention

09/04/09


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

Fever

UTI

09/04/09


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

Wound Infection

Malaria – dko lam if ksama pa tong malaria na ito!

09/04/09


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

RESULTS: total complications

p value = 0.05

Confidence interval = 95%

39


Table 2 see results on operating time table 3 see results on hospital stay pain relief

Table 2. See results on operating time

Table 3. See results on Hospital stay

Pain relief

Other endpoints measured

Table 2.

09/04/09


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

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

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Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

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

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Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

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.

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Clinical decision on harm

Clinical Decision on HARM


Clinical question1

Clinical Question

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


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

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


Articles appraised

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.


Relevance

Relevance


Validity

Validity


Validity1

Validity


Validity2

Validity


Validity3

Validity

Do the results of the harm study fulfill some of the tests for causation?


Validity4

Validity


Validity5

Validity


Applicability

Applicability


Conclusion

Conclusion

There was a significant reduction in antral follicle count and ovarian blood flow in the laparoscopy group.

However, the laparotomy group had significantly longer interval between the operation and assessment.

Longer interval between the time of operation and assessment in the laparoscopy group is recommended to rule out the possibility that the reduction in antral follicle count and ovarian blood flow is short-term.


Prognosis

Prognosis

Comments by the doctors are “italicized”

57


Search question

Search Question

  • What’s the fertility rate after surgical treatment for ectopic pregnancy?

  • Search terms:

    • Prognosis, fertility, ectopic pregnancy, surgery

    • Fertility, tubal pregnancy, surgery, salpingectomy

    • Fertility, tubal pregnancy, surgery, radical, conservative

58


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

59


Department of clinical epidemiology university of santo tomas faculty of medicine and surgery

Fertility following radical, conservative-surgical or medical treatment for tubal pregnancy: a population-based study.

Bouyer J, Job-Spira N, Pouly JL, Coste J, Germain E, Fernandez H.

INSERM U292, Bicêtre Hospital, Le Kremlin-Bicêtre, France.

60


Critical appraisal1

Critical Appraisal

61


Critical appraisal2

Critical Appraisal

62


Critical appraisal3

Critical Appraisal

63


Clinical appraisal

Clinical Appraisal

64


Results

Results

How large is the likelihood of outcome to occur in those with the prognostic factor in a specified period of time? Was it statistically significant?

65


Recurrent ectopic pregnancy

Recurrent Ectopic Pregnancy

Table 3. Recurrent ectopic pregnancy according to the initial treatment. Values are given as n or rate (95% CI), unless otherwise indicated

* P value of the log rank test between the 3 treatments

There’s no significant difference with regards to recurrence of ectopic pregnancy in between the 3 treatments.

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Crude cumulative rates of spontaneous intrauterine pregnancy

Crude Cumulative rates of spontaneous intrauterine pregnancy

Crudely:

Medical appears superior, followed by conservative surgical then radical being the lowest.

Fig 1. Crude cumultive rates of spontaneous intrauterine pregnancy according to initial treatment for EP (page 718, figure 1)

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Results1

Results

But after the multivariate analysis, there’s no significance in the cumulative rates of intrauterine pregnancy between the 3 treatments.

PS: In the table above, the data encoded are crude, but the entry for statistical significance is after multivariate analysis

Hazard ratio: In this study, the reference used was the conservative surgical because it’s the procedure mostly used by doctors. In computing for hazard ratio, the data in conservative was used as a denominator. For example in page 718, table 4, if hazard ratio of medical is 1.2, then it means that there’s a 1.2 more risk for medical compared to conservative-radical.

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Clinical appraisal1

Clinical Appraisal

69


Resolution of the problem in the scenario

Resolution of the Problem in the Scenario

In UST, if the baby is dead, both salphingostomy & salpingectomy is ethical & allowed. Although salpingostomy is more often used since it’s easier & has a shorter hospital stay. However if the baby is still alive then, salpingectomy is the only treatment that’s ethical

According to the study, there’s no significant difference between the treatments with regards to preserving fertility & recurrence of ectopic pregnancy

Salpingectomy will be recommended to the patient.

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