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Completed

NCT Number: NCT02822820

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Medical Faculty Hospital

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ligasure-Covidien

Device

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

RoBi forceps-Karl Storz

Device

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

Primary outcomes

  1. Duration of operation

    Time frame: six months

  2. Perioperative complications

    Time frame: six months

Secondary outcomes

  1. Pain measured by Visual Analog Scale

    Time frame: Postoperative pain scores at 8th and 24th hours

  2. Total cost of hospitalization, operation and complications

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 4, 2016
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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