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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-03-31

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.

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Detailed Description

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Conditions

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Perioperative Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Advanced bipolar (Ligasure-Covidien)

Devices with advanced bipolar energy (Ligasure-Covidien) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy

Group Type ACTIVE_COMPARATOR

Ligasure-Covidien

Intervention Type DEVICE

Vessel sealing device Ligasure-Covidien used during laparoscopic hysterectomy and pelvic lymphadenectomy

Conventional bipolar (RoBi forceps-Karl Storz)

Devices with conventional bipolar energy (RoBi rotating bipolar forceps-Karl Storz) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy

Group Type ACTIVE_COMPARATOR

RoBi forceps-Karl Storz

Intervention Type DEVICE

Vessel sealing device RoBi forceps-Karl Storz used during laparoscopic hysterectomy and pelvic lymphadenectomy

Interventions

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Ligasure-Covidien

Vessel sealing device Ligasure-Covidien used during laparoscopic hysterectomy and pelvic lymphadenectomy

Intervention Type DEVICE

RoBi forceps-Karl Storz

Vessel sealing device RoBi forceps-Karl Storz used during laparoscopic hysterectomy and pelvic lymphadenectomy

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No