The Comparison of Conventional and Advanced Bipolar Energy Modalities During Laparoscopic Staging Surgery of Gynecologic Cancers

Study Overview
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Brief Summary
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This single-institution prospective randomized clinical trial will be performed at the Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and cervix cancer who will be operated for staging via laparoscopic approach will be included in the study. The included patients will be randomized to two groups before surgery. During the operation of first group instruments with advanced bipolar energy will be used during lymphadenectomy and hysterectomy and salpingo-oophorectomy. In the second group the operation will be performed by conventional bipolar energy forceps. The outcome parameters to be measured are intra-operative bleeding, duration of operation, intraoperative complications, postoperative pain score, postoperative complications, postoperative duration of hospitalization, late complications such as lymphocele formation and costs.

Official Title
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The Impact of Bipolar Energy Modalities on Peri-operative Outcome During Laparoscopic Staging Surgery of Gynecologic Cancers: A Randomized Clinical Trial

Conditions
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Perioperative Period

Intervention / Treatment
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* Device: Ligasure-Covidien
* Device: RoBi forceps-Karl Storz


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologic diagnosis of endometrial or cervix cancer Stage I, IB1, IIA1 cervix cancer or patients with partial or complete response to chemoradiotherapy Clinically stage I and II endometrial cancer Exclusion Criteria: Hematologic abnormality Coagulation disorder Present or past thromboembolic disease ECOG performance >2 Advanced stage disease Fertility preserving surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Advanced bipolar (Ligasure-Covidien)<br>Devices with advanced bipolar energy (Ligasure-Covidien) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy | Device: Ligasure-Covidien<br>* Vessel sealing device Ligasure-Covidien used during laparoscopic hysterectomy and pelvic lymphadenectomy<br>|
| Active Comparator: Conventional bipolar (RoBi forceps-Karl Storz)<br>Devices with conventional bipolar energy (RoBi rotating bipolar forceps-Karl Storz) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy | Device: RoBi forceps-Karl Storz<br>* Vessel sealing device RoBi forceps-Karl Storz used during laparoscopic hysterectomy and pelvic lymphadenectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of operation |  | six months | 
| Perioperative complications |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured by Visual Analog Scale |  | Postoperative pain scores at 8th and 24th hours | 
| Total cost of hospitalization, operation and complications |  | six months |