Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer

This study has been completed.
Sponsor:
Information provided by:
Hospital Nossa Senhora da Conceicao
ClinicalTrials.gov Identifier:
NCT01258413
First received: December 9, 2010
Last updated: December 22, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Postoperative Pain
Procedure: Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy
Procedure: Abdominal radical hysterectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic vs Abdominal Radical Hysterectomy With Pelvic Lymphadenectomy in Patients With Early Cervical Cancer: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital Nossa Senhora da Conceicao:

Primary Outcome Measures:
  • postoperative pain measured by a 10 point numeric rating scale [ Time Frame: around one week ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Intraoperative, perioperative and postoperative complication [ Time Frame: 30 days or five years ] [ Designated as safety issue: Yes ]

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

    2. 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.


  • Surgicopathological outcomes [ Time Frame: postoperatively ] [ Designated as safety issue: No ]
    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.

  • Overall survival and disease-free survival [ Time Frame: five years ] [ Designated as safety issue: No ]
    Clinical status in the last visit recorded; Date and location of the first recurrence or metastasis. Time frame: five years from surgery


Enrollment: 30
Study Start Date: November 1999
Study Completion Date: February 2009
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic Radical Hysterectomy
uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament are removed + pelvic lymphadenectomy
Procedure: Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy
uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament + pelvic lymphadenectomy are removed by laparoscopic approach
Active Comparator: Abdominal radical hysterectomy
uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament are removed + pelvic lymphadenectomy
Procedure: Abdominal radical hysterectomy
uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament + pelvic lymphadenectomy are removed by abdominal approach

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01258413

Locations
Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
Sponsors and Collaborators
Hospital Nossa Senhora da Conceicao
Investigators
Principal Investigator: Leo F Limberger, M.D. Hospital Nossa Senhora da Conceição
  More Information

No publications provided by Hospital Nossa Senhora da Conceicao

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Leo Franscisco Limberger, Hospital Nossa Senhora da Conceição
ClinicalTrials.gov Identifier: NCT01258413     History of Changes
Other Study ID Numbers: CEPGHC: 65/99
Study First Received: December 9, 2010
Last Updated: December 22, 2010
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Nossa Senhora da Conceicao:
Cervical Cancer
Radical hysterectomy, Laparoscopic
Overall survival
Disease-free five-years survival

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Pain, Postoperative
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014