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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. Endometrial carcinoma. Most common gynecologic malignancy in developing world

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

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

endometrial carcinoma
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
standard treatment
Standard treatment

Worldwide:

TAH + BSO with or without

lymphadenectomy, through a vertical

midline incision

The Netherlands:

General gynecologist, TAH + BSO without

lymphadenectomy

disadvantages of standard treatment
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

background 1
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)

laparoscopy in the obese
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

laparoscopy in the elderly
Laparoscopy in the elderly
  • Shorter hospital stay
  • Less (wound)complications

Overall: age not a contraindication

for laparoscopy

Tozzi 2005, Scribner 2001

background 2
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)
background 3
Background 3

Laparoscopy seems safe and effective, however…

  • Only retrospective data
  • Pittfall: patient selection!
  • Also unexperienced gynecologists participated
  • Hysterectomy with lymphadenectomy
  • Not randomised !
pilot study aim
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
pilot study design
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)
pilot study complications17
Pilot Study - complications

# p = 0.08

* P < 0.05

pilot study conclusions
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
golden standard
Golden standard……

Randomised Controlled Trial !

randomised controlled trial tlh study
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!

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

Primary outcome: - major complications

Secundary outcome: - costs effectiveness

- minor complications

- quality of life

rct inclusion
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
rct exclusion
RCT- exclusion
  • Severe cardiopulmonary disease
  • Unfavourable histopathology
    • papillary serous carcinoma
    • clear cell adenocarcinoma
    • grade 3 adenocarcinoma
    • sarcoma
  • Earlier pelvic radiotherapy
rct state of affairs
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)
rct state of affairs26
RCT- state of affairs

Number of included patients: 11

slide27

UMCG

Justine M. Briët

Monique Kenkhuis

Truuske de Bock

Ate G.J. van der Zee

Marian J.E. Mourits

Henriette G.J. Arts