No registrations found.
ID
Source
Brief title
Health condition
Endometrial cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disease-free survival
Secondary outcome
Site of primary recurrence, overall survival and disease-specific survival
Background summary
This is a follow-up study of the Dutch randomised controlled, multi-centre TLH-TAH trial. Women with clinically stage I, low-grade endometrial cancer were randomized on a 2:1 basis either to TLH or TAH without lymphadenectomy. Aim was to provide the long-term survival outcomes. The current study used five-years follow-up data collected from the 19 participating centres. Our primary hypothesis was that a TLH is equally safe with respect to five-years disease-free survival outcomes in comparison to a TAH.
Study objective
Total laparoscopic hysterectomy is equally safe with respect to five-years disease-free survival outcomes in comparison to a total abdominal hysterectomy
Study design
Five years
Intervention
Total laparoscopic hysterectomy versus total abdominal hysterectomy
Inclusion criteria
Participants included in the initial TLH-TAH study. They previously included women with histologically proven grade 1-2 endometrioid adenocarcinoma or complex atypical hyperplasia, clinically confined to the uterin corpus (ie, clinical stage I).
Exclusion criteria
Exclusion criteria of the initial TLH-TAH study: any non-endometrioid adenocarcinoma histological types, uterine size larger than that expected at 12 weeks of pregnancy, and cardiopulmonary contraindications for laparoscopy of laparotomy.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9097 |
| Other | University Medical Center Groningen : NTR821 |