NCT01258413

Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer

Laparoscopic vs Abdominal Radical Hysterectomy With Pelvic Lymphadenectomy in Patients With Early Cervical Cancer: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hospital Nossa Senhora da Conceicao · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Cervical Cancer
• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy	uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament + pelvic lymphadenectomy are removed by laparoscopic approach
PROCEDURE	Abdominal radical hysterectomy	uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament + pelvic lymphadenectomy are removed by abdominal approach

Timeline

• Start date: 1999-11-01
• Primary completion: 2004-02-01
• Completion: 2009-02-01
• First posted: 2010-12-13
• Last updated: 2010-12-24

Locations

1 site across 1 country: Brazil