Laparoscopic vs Abdominal Radical Hysterectomy With Pelvic Lymphadenectomy in Patients With Early Cervical Cancer: A Randomized Clinical Trial
Background: Radical hysterectomy with pelvic lymphadenectomy is one of the FIGO
(International Federation of Gynecology and Obstetrics) recommended treatments for early
cervical cancer. The objective of this study was to compare radical hysterectomy by
laparoscopic approach and open radical hysterectomy in a single center randomized clinical
trial. Nevertheless, there are no finished randomized controlled trials comparing
laparoscopic radical hysterectomy and abdominal radical hysterectomy although there is an
ongoing trial.
Methods: Were enrolled 30 IA2 with lymph vascular space invasion and IB cervical cancer
patients. Postoperative pain intensity was defined as primary endpoint and pain intensity
was measured by a 10-point numeric rating scale. Secondary outcomes were: intraoperative and
other postoperative outcomes, histopathological outcomes and 5-year follow-up. Data
analysis is being done at this moment
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
postoperative pain measured by a 10 point numeric rating scale
The primary outcome is postoperative pain as measured by a 10-point numeric rating scale (NRS) during the postoperative period. Pain was assessed every six hours by nursing staff during a patient's usual postoperative care. The nursing staff was not aware of the study objective.
around one week
No
Leo F Limberger, M.D.
Principal Investigator
Hospital Nossa Senhora da Conceição
Brazil: Ministry of Health
CEPGHC: 65/99
NCT01258413
November 1999
February 2009
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