Postoperative Pain Clinical Trial
Official title:
Laparoscopic vs Abdominal Radical Hysterectomy With Pelvic Lymphadenectomy in Patients With Early Cervical Cancer: A Randomized Clinical Trial
The purpose of this study is to determine whether laparoscopic radical hysterectomy for early cervical cancer will has decreased postoperative pain intensity compared to abdominal radical hysterectomy with similar postoperative complications and survival rates.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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