Comparison of Perioperative Outcomes of Three Different Instruments in Total Laparoscopic Hysterectomy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01745315 |
Recruitment Status : Unknown
Verified January 2013 by Hakan Aytan, Adana Numune Training and Research Hospital.
Recruitment status was: Not yet recruiting
First Posted : December 10, 2012
Last Update Posted : January 30, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Perioperative Outcomes | Device: Advanced bipolar devices | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Comparison of the Use of LigaSure, Halo PKS Cutting Forceps and Enseal Tissue Sealer in Total Laparoscopic Hysterectomy: a Randomised Trial. |
Study Start Date : | February 2013 |
Estimated Primary Completion Date : | June 2013 |
Estimated Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: LigaSure (advanced bipolar device)
Laparoscopic hysterectomy will be done with LigaSure in 15 patients.
|
Device: Advanced bipolar devices
Other Names:
|
Active Comparator: Halo PKSforceps(advanced bipolar device)
Laparoscopic hysterectomy will be done with Halo PKS cutting forceps in 15 patients.
|
Device: Advanced bipolar devices
Other Names:
|
Active Comparator: EnSeal (advanced bipolar device)
Laparoscopic hysterectomy will be done with EnSeal in 15 patients.
|
Device: Advanced bipolar devices
Other Names:
|
- Perioperative Outcomes [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745315
Contact: Hakan Aytan, Associate Professor, M.D. | +905056833866 | drhakanaytan@yahoo.com |
Turkey | |
Adana Numune Training and Research Hospital | |
Adana, Turkey, 01150 | |
Contact: Hakan Aytan, Associate Professor, M.D. +905056833866 drhakanaytan@yahoo.com | |
Sub-Investigator: Hakan Nazik, M.D. | |
Sub-Investigator: Raziye Narin, M.D. | |
Sub-Investigator: Murat Api, M.D., PhD. | |
Principal Investigator: Hakan Aytan, M.D. |
Principal Investigator: | Hakan Aytan, M.D. | Adana Numune Training and Research Hospital |
Responsible Party: | Hakan Aytan, Associate Professor,, Adana Numune Training and Research Hospital |
ClinicalTrials.gov Identifier: | NCT01745315 |
Other Study ID Numbers: |
instruments in TLH |
First Posted: | December 10, 2012 Key Record Dates |
Last Update Posted: | January 30, 2013 |
Last Verified: | January 2013 |
total laparoscopic hysterectomy LigaSure EnSeal |
Halo PKS Cutting forceps electrothermal bipolar vessel sealer advanced bipolar device |