Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer

Hospital Nossa Senhora da Conceicao

Status and phase

Completed

Phase 3

Conditions

Postoperative Pain

Cervical Cancer

Treatments

Procedure: Abdominal radical hysterectomy

Procedure: Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01258413

CEPGHC: 65/99

Details and patient eligibility

About

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.

Full 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

Enrollment

30 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 approaches.