The comparison of surgical outcomes of using LigaSure and Gyrus PK in total laparoscopic hysterectomy

Comparison of operative time and blood loss using LigaSure and Gyrus PK in women undergoing total laparoscopic hysterectomy

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000649516

Enrollment

Registered

2015-06-23

Start date

2015-07-01

Completion date

2018-07-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a randomised controlled trial. All components used in this study are TGA approved. Women, who undergo a laparoscopic hysterectomy for benign indications will be randomised to the use of LigaSure or Gyrus PK blood vessel sealing devices. The aim is to compare operative time and blood loss with the use of LigaSure (LF 1737 5mm laparoscopic 37cm sealer /divider) versus Gyrus PK (5mm LYONS™ 33cm dissecting forceps) blood vessel sealing device during laparoscopic hysterectomy. A minimum of 64 patients will be enrolled into the study. Operating time (from initial skin incision until detachment of the uterus with secured haemostasis), total operating time (from initial skin incision until final skin closure), intra-operative blood loss, major complications, post-operative analgesia usage, conversion rate, ergonomics and costs will be evaluated.

Interventions

LigaSure and Gyrus PK are all TGA approved laparoscopic blood vessel sealing devices used in standard hospital care. They have been widely used in laparoscopic surgery for more than 15 years. The safety of these two instruments has been well established in clinical practice. We are evaluating their operative time and blood loss in laparoscopic gynaecological surgery.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

35 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients requiring hysterectomy for benign indications as determined jointly by the surgeon and the patient;Non-pregnant female patients;Over 35 years of age at time of surgery;Patients with the following (but not limited to) diagnoses: abnormal uterine bleeding, fibroids, prolapse;Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up; Patients who are capable of, and have given, informed consent to their participation in the study.

Exclusion criteria

Pregnancy or malignancy suspected ;Uterus exceeding 14 weeks in size

Outcome results