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

Perioperative Outcomes Clinical Trial

Official title:

Comparison of the Use of LigaSure, Halo PKS Cutting Forceps and Enseal Tissue Sealer in Total Laparoscopic Hysterectomy: a Randomised Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01745315
• Other study ID #: instruments in TLH
• Status: Not yet recruiting
• Phase: N/A
• First received: December 6, 2012
• Last updated: January 29, 2013
• Start date: February 2013
• Est. completion date: June 2013

Study information

• Verified date: January 2013
• Source: Adana Numune Training and Research Hospital
• Contact: Hakan Aytan, Associate Professor, M.D.
• Phone: +905056833866
• Email: drhakanaytan[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perioperative Outcomes

Intervention

Device:
• Advanced bipolar devices

Locations

Country	Name	City	State
Turkey	Adana Numune Training and Research Hospital	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Adana Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative Outcomes	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.	Until 45 patients are operated (6 months anticipated)	Yes