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

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.

Total Laparoscopic Hysterectomy Versus Total Abdominal Hysterectomy for Endometrial Cancer: A Meta-analysis

“…Six studies were further excluded including one study for no available data (Nicklin et al, 2011) and 5 overlapping studies (Tozzi et al, 2005;Zullo et al, 2005;Bijen et al, 2009;. Finally, nine randomized controlled trials with a total of 1263 patients were included into this meta-analysis (Fram, 2002;Tozzi et al, 2005;Zorlu et al, 2005;Chen and Huang, 2007;Wang, 2008;Malzoni et al, 2009;Zullo et al, 2009;Janda et al, 2010;Mourits et al, 2010).…”

Implementing an Advanced Laparoscopic Procedure by Monitoring with a Visiting Surgeon

“…The disadvantages of monitoring a learning curve in this manner is that it is time consuming and costly. In the present study, the visiting surgeon was supported by UMCG in an educational setting, and the study was a preparation for a larger trial [16]. We would suggest that with this study we demonstrated that a guided learning curve by an experienced colleague, using OSATS as the feedback instrument and for assessment, is a safe way to implement an advanced laparoscopic technique.…”

“…Because the advantages of laparoscopy over laparotomy in terms of quality of life and costeffectiveness can be proved only in a randomized study, we currently are conducting a multicenter, prospective, randomized controlled trial in the Netherlands [16]. All gynecologists who participated in the present study are participating in this randomized controlled trial, which reflects effective implementation of LH in these hospitals.…”

“…Because this was a feasibility and implementation study in preparation for a large randomized trial [16], there was no hypothesis testing, and a power calculation was not performed before the study. The regional hospitals were within 80 km of UMCG.…”

The Modern Surgical Strategy for Endometrial Cancer: Laparoscopic Surgery

“…Indeed, whilst endometrial cancer is the first gynecologic cancer to be treated laparoscopically, a laparoscopic approach also is being used for the surgical management of malignant disease. Following the first report on the use of laparoscopic surgery for endometrial cancer by Childers et al [12], the feasibility, safety, and efficacy of laparoscopic surgery in the surgical management of endometrial cancer has been reported in numerous retrospective studies [13][14][15][16][17][18][19][20][21][22][23][24][25], prospective nonrandomized studies [26][27][28][29], or randomized, controlled trials (RCTs) [30][31][32][33][34][35][36][37][38][39][40][41][42]43 This review provides an update on the role of laparoscopic surgery for the surgical management of endometrial cancer with particular emphasis on feasibility, safety, and efficacy based on the results of randomized, controlled trials comparing laparoscopy and laparotomy for surgical staging of endometrial cancer.…”