Laparoscopy versus laparotomy in the treatment of patients with early stage endometrial cancer

1. Laparoscopy versus laparotomy in the treatment of patients with early stage endometrial cancer Claudia B.M. Bijen Department of Gynecologic Oncology, University Medical Center Groningen, the Netherlands

2. Endometrial carcinoma • Most common gynecologic malignancy in developing world • Peak incidence: 55-65 year • Incidence increases by obesity and age • 1400 patients yearly, of which 75% stage I

3. Standard treatment Worldwide: TAH + BSO with or without lymphadenectomy, through a vertical midline incision The Netherlands: General gynecologist, TAH + BSO without lymphadenectomy

4. Disadvantages of standard treatment • Highly invasive • Visibly scarring • Substantial morbidity laparotomy due to frequent obesity and co-morbidity • Hospital stay ±1wk Manolitsas 2002, Obermair 2005

5. TLH, a good alternative?

6. The McCartney tube

7. The McCartney tube

8. Background 1 Potential pro’s of laparoscopy • Less post-operative pain • Quicker return to daily activity • Shorter hospital stay (2-3 vs 7 days) • Less wound complications (2% vs 48%) • Higher quality of life • Similar recurrence rate • Especially feasible for obese and elderly! Eltabbakh 2001,Fram 2002, Manolitsas 2002, Obermair 2003) Obermair 2004)

9. Laparoscopy in the obese • Safe and feasible • Similar complication rates • Shorter hospitalization • Less pain, less wound infections • Increased conversion risk Heinberg 2004, Eltabbakh 2000, Obermair 2005, Holub 2000

10. Laparoscopy in the elderly • Shorter hospital stay • Less (wound)complications Overall: age not a contraindication for laparoscopy Tozzi 2005, Scribner 2001

11. Background 2 Potential disadvantages of laparoscopy • Longer operation time • Longer learning curve • Higher per-operative costs (disposables, OR time) • More per-operative complications (ureter lesions)

12. Background 3 Laparoscopy seems safe and effective, however… • Only retrospective data • Pittfall: patient selection! • Also unexperienced gynecologists participated • Hysterectomy with lymphadenectomy • Not randomised !

13. Pilot study - aim • Investigate the feasibility of TLH in patients with early stage EC • Evaluate the concept of visiting surgeon and the use of OSATS during the learning curve

14. Pilot Study -design • Participating centres: UMCG and 7 northern clinics • TLH procedure instead of abdominal hysterectomy • Early stage endometrial carcinoma • Benign pathology • One (or 2) gynecologist per center • Visiting surgeon evaluated learning curve with help of OSATS • Before and after pass grade OSATS score • Complications per- en postoperative • Duration of procedure (min)

15. Pilot Study -major complications

16. Pilot Study- complications

17. Pilot Study - complications # p = 0.08 * P < 0.05

18. Pilot Study -conclusions • Experienced gynaecologists reach the cut off value of 28 points in reasonable time (3-13 x) • The use of OSATS to evaluate the competence of the gynaecologists to perform a TLH seems feasible

19. Golden standard…… Randomised Controlled Trial !

20. Randomised controlled trial TLH study • Only RCT can answer the question, which procedure is the best for the patient • No randomised data about laparoscopy (without lymphadenectomy) in patients with early stage endometrial cancer • No cost-effectiveness data available • Complication rate is low with experienced gynecologists ↓ RCT was assigned January 2007!

21. RCT -design • Multi –centre: 20 participating centers • Duration: 3 years (start January 2007) • Total number of patients needed: 275

22. RCT – outcome Primary outcome: - major complications Secundary outcome: - costs effectiveness - minor complications - quality of life

23. RCT -inclusion • Endometrioid adenocarcinoma • stage I, grade 1-2 • Without cervical involvement (curettage/biopsy) • Premalignant lesions (atypical hyperplasia) • Uteri not larger than ~12 weeks pregancy • Age ≥18 jaar • Signed informed consent

24. RCT- exclusion • Severe cardiopulmonary disease • Unfavourable histopathology • papillary serous carcinoma • clear cell adenocarcinoma • grade 3 adenocarcinoma • sarcoma • Earlier pelvic radiotherapy

25. RCT- state of affairs Participating centres: • Amsterdam - Vrij Universitair Medisch Centrum Amsterdam • Amsterdam - Onze Lieve Vrouwe Gasthuis Amsterdam • Amsterdam - St Lucas Andreas ziekenhuis Amsterdam • Amsterdam - Academisch Medisch Centrum Amsterdam • Arnhem - Ziekenhuis Rijnstate Arnhem • Assen - Wilhelmina Ziekenhuis Assen • Drachten - Ziekenhuis Nij Smellinghe • Emmen - Scheper Ziekenhuis Emmen • Enschede - Medisch Spectrum Twente • Gouda - Groene Hart Ziekenhuis Gouda • Groningen - Universitair Medisch Centrum Groningen • Groningen - Martini ziekenhuis Groningen • Haarlem - Kennemer Gasthuis Haarlem • Hengelo - Ziekenhuisgroep Twente • Leeuwarden - Medisch Centrum Leeuwarden • Leiden - Leids Universitair Medisch Centrum • Maastricht - Academisch Ziekenhuis Maastricht • Nijmegen - UMC St. Radboud • Sneek - Antonius Ziekenhuis Sneek • Veldhoven - Maxima Medisch Centrum • Venlo - Vie Curie Medisch Centrum Noord-Limburg • Zwolle - Isala Klinieken (Locatie Sophia)

26. RCT- state of affairs Number of included patients: 11

27. UMCG Justine M. Briët Monique Kenkhuis Truuske de Bock Ate G.J. van der Zee Marian J.E. Mourits Henriette G.J. Arts