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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02822820

Enrollment

Registered

2016-07-04

Start date

2016-07-31

Completion date

2017-03-31

Last updated

2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Period

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.

Interventions

DEVICELigasure-Covidien

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

DEVICERoBi forceps-Karl Storz

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Duration of operation	six months
Perioperative complications	six months

Secondary

Measure	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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026