Total laparoscopic hysterectomy versus abdominal hysterectomy in the treatment of patients with early stage endometrial cancer: A randomized multi center studyReportar como inadecuado




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BMC Cancer

, 9:23

First Online: 15 January 2009Received: 22 December 2008Accepted: 15 January 2009DOI: 10.1186-1471-2407-9-23

Cite this article as: Bijen, C.B., Briët, J.M., de Bock, G.H. et al. BMC Cancer 2009 9: 23. doi:10.1186-1471-2407-9-23

Abstract

BackgroundTraditionally standard treatment for patients with early stage endometrial cancer EC is total abdominal hysterectomy and bilateral salpingo oophorectomy TAH+BSO with or without lymph node dissection through a vertical midline incision. While TAH is an accepted effective treatment, it is highly invasive, visibly scarring and associated with morbidity. An alternative treatment is the same operation by laparoscopy. Though in several studies total laparoscopic hysterectomy TLH+ BSO seems a safe and feasible alternative approach in early stage endometrial cancer patients, there are no randomized data available yet. Furthermore, a randomized controlled trial with surgeons trained in laparoscopy is warranted in order to implement this technique in a safe manner. The aim of this study is to compare the treatment related morbidity, cost-effectiveness and quality of life in early stage endometrial cancer patients treated by laparoscopy versus the standard open approach.

MethodsA multi centre randomized clinical phase 3 trial, including 5 university hospitals and 15 regional hospitals in the Netherlands. Only gynecologists trained in performing a TLH are allowed to participate. Inclusion criteria: Patients with a clinical stage I endometrioid adenocarcinoma or complex atypical hyperplasia are randomized in a 2:1 allocation to receive TLH or TAH. The main outcome measure is the rate of major complications, as assessed by an independent clinical review board. In total, 275 patients are required to have 80% power at α-0.05 to detect a significant difference of 15% complication rate. Secondary outcome measures are 1 costs and cost-effectiveness, 2 minor complications, and 3 quality of life. All data from this multi center study are reported using case record forms. Data regarding quality of life, pain, body Image, sexuality and additional homecare are assessed with self reported questionnaires.

DiscussionA randomized multi center study in early stage endometrial cancer patients with inclusion criteria for patients and surgeons is designed and ongoing. Results will be presented at the end of 2009.

Trial RegistrationDutch trial register number NTR821.

AbbreviationsBISBody Image Scale

BSOBilateral Salpingo Oophorectomy

CRFCase Record Form

CTCAECommon Terminology Criteria of Adverse Events

DVTDeep Venous Thrombosis

ECEndometrial Cancer

EQ-5DEuroQol-5 dimensional

OSATSObjective Structured Assessment of Technical Skills

SAQSexual Activity Questionnaire

SF-36Short Form-36

TAHTotal Abdominal Hysterectomy

TCCTrial Coordination Center

TLHTotal Laparoscopic Hysterectomy

VASVisual Analogue Scale

WMOWet Medisch Wetenschappelijk Onderzoek.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2407-9-23 contains supplementary material, which is available to authorized users.

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