A randomised controlled trial comparing the LigaSure Retractable L Hook with the Harmonic ACE +7 Scalpel for use as a single instrument to complete a total laparoscopic hysterectomy for benign conditions in a normal sized uterus.
- Conditions
- total laparoscopic hysterectomySurgery - Other surgery
- Registration Number
- ACTRN12620000511932
- Lead Sponsor
- Sydney West Advanced Pelvic Surgery Unit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 86
Benign indication for hysterectomy (including but not limited to: abnormal uterine bleeding, fibroid uterus, pelvic organ prolapse)
-Hysterectomies can include removal of adenxae (eg bilateral salpingectomy, or oophprectomy etc)
-Non-pregnant
-BMI less than 40
-Uterus less than 14 week size
-No other pre-planned concurrent surgical procedures such as pelvic floor repair, excision of endometriosis etc
-Surgery performed by consultant gynaecologist and/or laparoscopic fellow
-Patients able to understand the nature of the study, provide consent for participation and willing to commit to 6-week follow-up
-Suspected or confirmed uterine malignancy (as determined by the Investigator based on prior endometrial biopsy, imaging or clinical appearance)
-Unanticipated surgical difficulty likely to provide complexity unrelated to TLH (eg extensive abdominal adhesions, extensive endometriosis)
-Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method