Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Cervical Cancer; Postoperative Pain	Procedure: Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy; Procedure: Abdominal radical hysterectomy	Phase 3

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	November 1999
Actual Primary Completion Date :	February 2004
Actual Study Completion Date :	February 2009

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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.

   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.

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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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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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
First Posted:	December 13, 2010
Last Update Posted:	December 24, 2010
Last Verified:	November 2010

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; Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Signs and Symptoms