Comparison of Perioperative Outcomes of Three Different Instruments in Total Laparoscopic Hysterectomy

Not Applicable

• Conditions: Perioperative Outcomes
• Interventions: Device: Advanced bipolar devices

• Registration Number: NCT01745315
• Lead Sponsor: Adana Numune Training and Research Hospital

Brief Summary

There are many instruments with different energy modalities or with different properties that are available for use in total laparoscopic hysterectomy. The aim of the present study is to compare three of these instruments that are present in our clinic - HALO PKS Cutting Forceps, LigaSure and Enseal Tissue Sealer, in total laparoscopic hysterectomy with respect to operation time, blood loss, change in hemoglobin / hematocrit levels, perioperative complications, return of gastrointestinal activity and hospitalization time.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-29
• Last Update Posted: 2013-01-30
• Study Start: 2013-02
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• any women with the indication of hysterectomy

Exclusion Criteria

• malignancy
• having 3 or more previous abdominal surgeries
• uterus being larger than 12 weeks of gestation
• patients who must undergo additional surgical procedures during the same operation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LigaSure (advanced bipolar device)	Advanced bipolar devices	Laparoscopic hysterectomy will be done with LigaSure in 15 patients.
Halo PKSforceps(advanced bipolar device)	Advanced bipolar devices	Laparoscopic hysterectomy will be done with Halo PKS cutting forceps in 15 patients.
EnSeal (advanced bipolar device)	Advanced bipolar devices	Laparoscopic hysterectomy will be done with EnSeal in 15 patients.

Primary Outcome Measures

Name	Time	Method
Perioperative Outcomes	Until 45 patients are operated (6 months anticipated)	Perioperative outcomes will be assessed with respect to complication rates, operation time, blood loss, change in hemoglobin and hemotocrit levels, time to return of gastrointestinal function and hospitalization time.

Trial Locations

Locations (1)

Adana Numune Training and Research Hospital; 🇹🇷 Adana, Turkey