Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer
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| ClinicalTrials.gov Identifier: NCT01258413 |
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Recruitment Status :
Completed
First Posted : December 13, 2010
Last Update Posted : December 24, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Cancer Postoperative Pain | Procedure: Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy Procedure: Abdominal radical hysterectomy | Phase 3 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Laparoscopic Radical Hysterectomy
uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament are removed + pelvic lymphadenectomy
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Procedure: Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy
uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament + pelvic lymphadenectomy are removed by laparoscopic approach |
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Active Comparator: Abdominal radical hysterectomy
uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament are removed + pelvic lymphadenectomy
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Procedure: Abdominal radical hysterectomy
uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament + pelvic lymphadenectomy are removed by abdominal approach |
- 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.
- 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.
- 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.
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258413
| Brazil | |
| Hospital Nossa Senhora da Conceição | |
| Porto Alegre, Rio Grande do Sul, Brazil, 91350-200 | |
| Principal Investigator: | Leo F Limberger, M.D. | Hospital Nossa Senhora da Conceição |
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 |
| First Posted: | December 13, 2010 Key Record Dates |
| Last Update Posted: | December 24, 2010 |
| Last Verified: | November 2010 |
Keywords provided by Hospital Nossa Senhora da Conceicao:
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Cervical Cancer Radical hysterectomy, Laparoscopic Overall survival Disease-free five-years survival |
Additional relevant MeSH terms:
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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 |