Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer

Phase 3

Completed

• Conditions: Cervical Cancer; Postoperative Pain
• Interventions: Procedure: Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy; Procedure: Abdominal radical hysterectomy

• Registration Number: NCT01258413
• Lead Sponsor: Hospital Nossa Senhora da Conceicao

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.

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 Timeline

• Study Start: 1999-11
• Primary Completion: 2004-02
• Study Completion: 2009-02
• Status Verified: 2010-11
• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-10
• Study First Posted: 2010-12-13
• Last Update Submitted: 2010-12-22
• Last Update Posted: 2010-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic Radical Hysterectomy	Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy	uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament are removed + pelvic lymphadenectomy
Abdominal radical hysterectomy	Abdominal radical hysterectomy	uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament are removed + pelvic lymphadenectomy

Primary Outcome Measures

Name	Time	Method
postoperative pain measured by a 10 point numeric rating scale	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

Name	Time	Method
Intraoperative, perioperative and postoperative complication	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	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	five years	Clinical status in the last visit recorded; Date and location of the first recurrence or metastasis. Time frame: five years from surgery

Trial Locations

Locations (1)

Hospital Nossa Senhora da Conceição; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil