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Clinical Trial Summary

The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who are randomised to receive Total Laparoscopic Hysterectomy (TLH) and patients who are randomised to receive Total Abdominal Hysterectomy (TAH).


Clinical Trial Description

This phase III international, multicenter, open-label, randomized clinical trial is an equivalence study with the hypothesis is that Total Laparoscopic Hysterectomy (TLH) is associated with equivalent disease-free survival when compared to the standard treatment of Total Abdominal Hysterectomy (TAH) for women with apparent Stage I endometrial cancer.

The secondary hypotheses are:

- TLH is associated with equivalent or improved Quality of Life (QoL) at 6 months;

- TLH is associated with reduced treatment-related morbidity;

- TLH is associated with shorter hospital stay;

- TLH is associated with less analgesic consumption;

- TLH is cost effective;

- TLH is associated with improved pelvic floor function. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00096408
Study type Interventional
Source Queensland Centre for Gynaecological Cancer
Contact
Status Completed
Phase Phase 3
Start date October 2005
Completion date December 2018

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