POW Journal Club 11 th September 2006

1. POW Journal Club11th September 2006 Laparoscopic Cholecystectomy and Interval Endoscopy For Gallstone Complications During Pregnancy P. Sungler, P.M. Heinerman, H. Steiner, H. W. Waclawiczek, J. Holizingler, F. Mayer, A. Heuberger, O. Boeckl Surgical Endoscopy 2000 14: 267- 271

2. Choosing Article • Based on Previous Journal Club Discussion • Medline Database • Many Articles – Few RCTs and none specifically answered question

3. Background • 1-3% Pregnant women have a surgical procedure unrelated to their pregnancy • Gallstones present 4.5-12% all pregnancies • Biliary disease is 2nd commonest (to appendicitis) • Aim is for conservative management to protect foetus – significant amount fail (1/3)

4. Background • Spontaneous Abortion rate 12% symptomatic cholelithiasis in 1st trimester • Maternal mortality 37% and foetal death 10-60% with increasing complications • 1st trimester OT has risks for preterm labour, teratogenesis and miscarriage • 3rd trimester also has technical difficulties and premature labour in <40%

5. Background • Hypothesis • Laparoscopic surgery is not without risks, but it should be considered for pregnant women with biliary disease • Purpose study • Claims to be a prospective assessment of the suitability of treatments and outcomes of surgical treatments • Aims are not clearly explained

6. Study Design • Prospectively recruited Pts if they were pregnant with biliary disease & confirmed with USS (Salzburg, Austria – during 4yr period) • Initial conservative management for all Pts • ?Randomised • When obstructive jaundice or pancreatitis, ERCP then cholecystectomy (some proceeded to OT without ERCP – pain/colic, choelcystitis) • No Intraop-cholangiograms (radiation) • ?Controlled • No blinding

7. Results • 37 Pts entered • 25 managed conservatively • 12 included for intervention • 3 ERCP only • 2 ERCP + OT • 7 OT only • All but 1 were in 2nd trimester

8. Results • From ERCP “Group” (5) • 1 persistent colic – Lap Chole (32/40) • 1 represented after initial dx of pancreatitis and had perf GB – recovered well after OT • From OT “Group” (7) • No complications but tocolytics required in 2 (25 and 32/40). ?Preterm labour • No statistical analysis performed……

9. Literature Review • Total 194 cases of Lap Chole and 45 ERCP • No meta-analysis or weighting of publications • Limited numbers per publication • ?Publication Bias – only publishing favourable results……

10. Conclusions from Paper • No maternal complication, preterm delivery or foetal loss or teratogenicity • 3rd trimester OT not ideal from anatomical perspective – perhaps RUQ for needle (Veress). Based on other work not from this paper • Suggests pressures of 10mmHg if OT required but obviously aim for conservative management • Supports Intervention when conservative fails

11. Execution of the Study • Sample size – Small but difficult to recruit • Confounding variables – not accounted for. No control, or clear goals • Follow up not commented upon – but talks of foetal complications being none • Statistical analysis lacking

12. Assessment of Conclusion • Weaknesses • Journal – Surgical Endoscopy • Aims not clear • Not prospective – Case Series • No control • Numbers small • Draws conclusions

13. Assessment of Conclusion • Strengths • Attempt to pool other data – badly • Nothing better as difficult to perform RCT in this group

14. Application of Study • Currently aware that preferable to avoid OT, but risks are obvious if ignore acute surgical diagnosis • Surgery can be performed at all trimesters with good outcome for mother and foetus • Numbers small, paper poor, but continue to practise as thought