Know Cancer

forgot password

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

Phase 3
18 Years
Not Enrolling
Cervical Cancer, Postoperative Pain

Thank you

Trial Information

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

Inclusion Criteria:

- Women of 18 years or older referred to our service with histologically confirmed
primary squamous, adenocarcinoma or adenosquamous cervical cancer diagnosed by biopsy
or cervical conization, clinically FIGO (International Federation of Gynecologic and
Obstetrics) staged IA2 with lymph vascular invasion, IB and II A.

Exclusion Criteria:

- Patients with clinically advanced disease (IIB-IV), previous pelvic or abdominal
radiotherapy, pregnancy, clinical diseases that would preclude one or both surgical

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

postoperative pain measured by a 10 point numeric rating scale

Outcome Description:

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.

Outcome Time Frame:

around one week

Safety Issue:


Principal Investigator

Leo F Limberger, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Nossa Senhora da Conceição


Brazil: Ministry of Health

Study ID:

CEPGHC: 65/99



Start Date:

November 1999

Completion Date:

February 2009

Related Keywords:

  • Cervical Cancer
  • Postoperative Pain
  • Cervical Cancer
  • Radical hysterectomy, Laparoscopic
  • Overall survival
  • Disease-free five-years survival
  • Uterine Cervical Neoplasms
  • Pain, Postoperative