Total laparoscopic hysterectomy is equally safe with respect to five-years disease-free survival outcomes in comparison to a total abdominal hysterectomy
ID
Bron
Verkorte titel
Aandoening
Endometrial cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Disease-free survival
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Total laparoscopic hysterectomy is equally safe with respect to five-years disease-free survival outcomes in comparison to a total abdominal hysterectomy
Onderzoeksopzet
Five years
Onderzoeksproduct en/of interventie
Total laparoscopic hysterectomy versus total abdominal hysterectomy
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9097 |
| Ander register | University Medical Center Groningen : NTR821 |