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

A

Ankara University

Status

Completed

Conditions

Perioperative Period

Treatments

Device: Ligasure-Covidien
Device: RoBi forceps-Karl Storz

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

68 participants in 2 patient groups

Advanced bipolar (Ligasure-Covidien)
Active Comparator group
Description:
Devices with advanced bipolar energy (Ligasure-Covidien) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy
Treatment:
Device: Ligasure-Covidien
Conventional bipolar (RoBi forceps-Karl Storz)
Active Comparator group
Description:
Devices with conventional bipolar energy (RoBi rotating bipolar forceps-Karl Storz) will be used during laparoscopic hysterectomy and pelvic lymphadenectomy
Treatment:
Device: RoBi forceps-Karl Storz

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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