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

NCT02822820 | Completed

• 1 other identifier: 03
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Period

Outcome Measures

Primary Outcomes (2)

• Duration of operation

  six months

• Perioperative complications

  six months

Secondary Outcomes (2)

• Pain measured by Visual Analog Scale

  Postoperative pain scores at 8th and 24th hours

• Total cost of hospitalization, operation and complications

  six months

Study Arms (2)

Advanced bipolar (Ligasure-Covidien)

ACTIVE COMPARATOR

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

Device: Ligasure-Covidien

Conventional bipolar (RoBi forceps-Karl Storz)

ACTIVE COMPARATOR

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

Device: RoBi forceps-Karl Storz

Interventions

Ligasure-Covidien DEVICE

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

Advanced bipolar (Ligasure-Covidien)

RoBi forceps-Karl Storz DEVICE

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

Conventional bipolar (RoBi forceps-Karl Storz)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hematologic abnormality
• Coagulation disorder
• Present or past thromboembolic disease
• ECOG performance \>2
• Advanced stage disease
• Fertility preserving surgery

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Medical Faculty Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• Taskin S, Sukur YE, Altin D, Turgay B, Varli B, Baytas V, Ortac F. Bipolar Energy Instruments in Laparoscopic Uterine Cancer Surgery: A Randomized Study. J Laparoendosc Adv Surg Tech A. 2018 Jun;28(6):645-649. doi: 10.1089/lap.2017.0639. Epub 2018 Jan 11.

  PMID: 29323616 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 4, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

TU (1)