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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

December 9, 2010
December 22, 2010
November 1999
February 2004   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01258413 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervical Cancer
  • Postoperative Pain
  • 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
  • Experimental: Laparoscopic Radical Hysterectomy
    uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament are removed + pelvic lymphadenectomy
    Intervention: Procedure: Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy
  • Active Comparator: Abdominal radical hysterectomy
    uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament are removed + pelvic lymphadenectomy
    Intervention: Procedure: Abdominal radical hysterectomy
Campos LS, Limberger LF, Stein AT, Kalil AN. Postoperative pain and perioperative outcomes after laparoscopic radical hysterectomy and abdominal radical hysterectomy in patients with early cervical cancer: a randomised controlled trial. Trials. 2013 Sep 12;14:293. doi: 10.1186/1745-6215-14-293.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2009
February 2004   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01258413
CEPGHC: 65/99
No
Dr. Leo Franscisco Limberger, Hospital Nossa Senhora da Conceição
Hospital Nossa Senhora da Conceicao
Not Provided
Principal Investigator: Leo F Limberger, M.D. Hospital Nossa Senhora da Conceição
Hospital Nossa Senhora da Conceicao
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP