Laparoscopy versus laparotomy in the treatment of patients with early stage endometrial cancer - PowerPoint PPT Presentation

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

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

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  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