Transvaginal hysterectomy Urological and Genital Diseases Transvaginal hysterectomy
Conditions
Interventions
Patients who sign an informed consent will be enrolled in the study upon verification that all inclusion and exclusion criteria have been met. Patients’ demographics and medical histories will be coll
Sponsors
Covidien Private Limited
Eligibility
Sex/Gender
Female
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operative time is measured as the duration from the time of skin incision to the time of final suture in skin closure during surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Operative blood loss is measured by weighing the sponges and gauze pads used during the operation, and measuring the drainage containers/suction bottle post-operatively 2. Length of hospital stay is assessed by measuring the time between hospital admission and discharge 3. Surgical complications (e.g. bleeding, hematoma, micturition, abnormal defecation, decreased appetite, fatigue, myalgia and pain), will be assessed by the investigator and recorded in the CRF as adverse events. It will be assessed from operation day till post-operation day 30 4. Surgery costs will be calculated by capturing of cost in the CRFs. The cost may include (but not limited to), surgery cost and instruments cost, anaesthesia used (duration and cost), post-operative analgesic used (duration and cost), and hospitalization cost. Self-payment, co-payment, and insurance coverage of the surgery information will also be captured in the CRF. 5. Post-operative pain intensity will be assessed by the visual analogue scale (VAS) at least twice daily by the patient until the patient is discharged from the hospital 6. Blood samples will be taken at Pre-Op (1 day before operation, 15 mL) and Post-Op Day 1 (10 mL) for routine safety laboratory tests and stress hormones. The safety laboratory tests, including hematology tests (red blood cells count, white blood cells count and its differentials, platelet count, hemoglobin and hematocrit) and biochemistry tests (AST, ALT, bilirubin, creatinine, total protein and BUN), will be assessed by the hospital central laboratory. Both hematology and biochemistry tests will be assessed before the surgery; however, only hematology tests will be assessed at the next day after the surgery. Stress hormones or cytokine levels including interleukin-6 (IL-6), interleukin-1 beta (IL-1B), Tumor necrosis factor - alpha (TNF-a) and C-reactive protein (CRP), will be assessed before the surgery and at the next day after the surgery by the hospital central laboratory or the desi | — |
Countries
Taiwan
Contacts
Public ContactWendy Lim
Outcome results
None listed