Skip to main content
OpenTrials
Completed

NCT Number: NCT01258413

Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy

Procedure

uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament + pelvic lymphadenectomy are removed by laparoscopic approach

Abdominal radical hysterectomy

Procedure

uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament + pelvic lymphadenectomy are removed by abdominal approach

Primary outcomes

  1. postoperative pain measured by a 10 point numeric rating scale

    Time frame: around one week

    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.

Secondary outcomes

  1. Intraoperative, perioperative and postoperative complication

    Time frame: 30 days or five years

    1 Intraoperative outcomes included the following: operative time (minutes), injuries to the ureter, bladder, bowel or vessels and anaesthesia complications requiring blood transfusion.

    • Early (< 30 days) or late postoperative events and findings during the hospital stay or after included the following: hospital stay duration (days), complications. Surgical or clinical findings that could be attributable to the treatment in five years of follow up 74 Clinical or surgical findings that could be attributable to the treatment or the disease at five years of follow-up.

  2. Surgicopathological outcomes

    Time frame: postoperatively

    outcomes included the following: histological type, surgical margins, lymph node status and lymph node number, all assessed by pathologists with expertise in gynaecologic oncology. In addition, parametrial and vaginal cuff width (centimetres) was assessed by the first surgeon in the operating room, before tissue processing.

  3. Overall survival and disease-free survival

    Time frame: five years

    Clinical status in the last visit recorded; Date and location of the first recurrence or metastasis. Time frame: five years from surgery

Sponsors and collaborators

Lead sponsor

Hospital Nossa Senhora da Conceicao

Other

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2004
Study completion
2009
First posted
Dec 13, 2010
Registry last updated
Dec 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.