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

Perioperative Period Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822820
• Other study ID #: 03
• Status: Completed
• Phase: N/A
• First received: June 24, 2016
• Last updated: April 22, 2017
• Start date: July 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perioperative Period

Intervention

Device:
• Ligasure-Covidien
Vessel sealing device Ligasure-Covidien used during laparoscopic hysterectomy and pelvic lymphadenectomy
• RoBi forceps-Karl Storz
Vessel sealing device RoBi forceps-Karl Storz used during laparoscopic hysterectomy and pelvic lymphadenectomy

Locations

Country	Name	City	State
Turkey	Ankara University Medical Faculty Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of operation		six months
Primary	Perioperative complications		six months
Secondary	Pain measured by Visual Analog Scale		Postoperative pain scores at 8th and 24th hours
Secondary	Total cost of hospitalization, operation and complications		six months