ISRCTN13646289
Completed
Not Applicable
An Investigational Study of the Effectiveness and Safety of the LigaSure™ Tissue Fusion System in Hysterectomy via Transvaginal Natural Orifice Transluminal Endoscopic Surgery (NOTES)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transvaginal hysterectomy
- Sponsor
- Covidien Private Limited
- Enrollment
- 72
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female patients 35 years of age or older
- •2\. Scheduled to undergo a transvaginal NOTES hysterectomy
- •3\. Willing to provide informed consent
Exclusion Criteria
- •1\. Multiple abdominal surgery, except caesarean section
- •2\. History of coagulation disorder
- •3\. History of liver and renal dysfunction within 6 months prior to inclusion into the study
- •4\. Severe inflammatory diseases
- •5\. Malignancy
- •6\. Electrosurgery contraindicated
- •7\. Hypersensitivity to or unable to tolerate general anesthesia or analgesic
- •8\. Those participating any clinical trials within 3 months prior to the intervention
- •9\. Not suitable for surgical intervention at the discretion of the investigator
Outcomes
Primary Outcomes
Not specified
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