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

Not Applicable

Completed

• Conditions: Perioperative Period
• Interventions: Device: Ligasure-Covidien; Device: RoBi forceps-Karl Storz

• Registration Number: NCT02822820
• Lead Sponsor: Ankara University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-24
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-04
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-22
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advanced bipolar (Ligasure-Covidien)	Ligasure-Covidien	Devices with advanced bipolar energy (Ligasure-Covidien) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy
Conventional bipolar (RoBi forceps-Karl Storz)	RoBi forceps-Karl Storz	Devices with conventional bipolar energy (RoBi rotating bipolar forceps-Karl Storz) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy

Primary Outcome Measures

Name	Time	Method
Duration of operation	six months
Perioperative complications	six months

Secondary Outcome Measures

Name	Time	Method
Pain measured by Visual Analog Scale	Postoperative pain scores at 8th and 24th hours
Total cost of hospitalization, operation and complications	six months

Trial Locations

Locations (1)

Ankara University Medical Faculty Hospital; 🇹🇷 Ankara, Turkey