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

NCT ID: NCT01745315

Last Updated: 2013-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Perioperative Outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LigaSure (advanced bipolar device)

Laparoscopic hysterectomy will be done with LigaSure in 15 patients.

Group Type ACTIVE_COMPARATOR

Advanced bipolar devices

Intervention Type DEVICE

Halo PKSforceps(advanced bipolar device)

Laparoscopic hysterectomy will be done with Halo PKS cutting forceps in 15 patients.

Group Type ACTIVE_COMPARATOR

Advanced bipolar devices

Intervention Type DEVICE

EnSeal (advanced bipolar device)

Laparoscopic hysterectomy will be done with EnSeal in 15 patients.

Group Type ACTIVE_COMPARATOR

Advanced bipolar devices

Intervention Type DEVICE

Interventions

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Advanced bipolar devices

Intervention Type DEVICE

Other Intervention Names

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LigaSure Halo PKS cutting forceps EnSeal

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Adana Numune Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hakan Aytan

Associate Professor,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hakan Aytan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Adana Numune Training and Research Hospital

Locations

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Adana Numune Training and Research Hospital

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Hakan Aytan, Associate Professor, M.D.

Role: CONTACT

+905056833866

Facility Contacts

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Hakan Aytan, Associate Professor, M.D.

Role: primary

+905056833866

Other Identifiers

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instruments in TLH

Identifier Type: -

Identifier Source: org_study_id

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