Subjects undergoing transurethral soft tissue dissection
Conditions
Interventions
experimental group:Endoscopic surgery control system
matched group:Transurethral resection
Sponsors
Peking Union Medical College Hospital ,Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 95 Years
Inclusion criteria
Inclusion criteria: (1) Over 18 years old; (2) Subjects requiring transurethral soft tissue dissection; (3) The American Society of Anesthesiologists (ASA) Physical status classification system is graded as class I to Class III; (4) Patients who voluntarily sign informed consent and are willing to cooperate with doctors to complete relevant treatment, examination and follow-up.
Exclusion criteria
Exclusion criteria: (1) A pacemaker has been installed; (2) Combined with systemic or uncontrolled local infection, active urinary tract infection, urethral injury, severe urethral stricture or malformation, malignancies other than prostate or bladder cancer, bladder neck contracture, bladder stones or other vital organ (heart, liver, kidney, lung) failure or neurological disease that may affect surgery; (3) Diagnosed hip stiffness, or received femoral head replacement surgery, lumbosacral spinal metal implantation surgery; (4) Pregnant or lactating women; (5) Absolute neutrophil count (ANC) = 10.0mmol/L; (7) Severe coagulation dysfunction (2 times the upper limit of normal APTT or PT); (8) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal value; (9) Participating in clinical trials of other drugs or medical devices within 1 month before enrollment; (10) In the interest of the subjects, the investigator considers that they should not participate in other situations in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| success rate of operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative time;blood loss;blood transfusion rate;Postoperative catheterization time;postoperative hospitalization days;patient pain score fVA ;from the time the instrument entered urethra to the postoperative period Overall complication rate of 30± 3 days (Chvien to Dindo grade I or higher) ; re-entry within 30± 3 days Hospitalization rate;reoperation rate;mortality rate;Postoperative investigator satisfaction with the instrument (including the NAsA¯ TLX scale) was used to assess the operator's performance in the operating device The degree of work load during preparation;Postoperative investigator satisfaction with the instrument(the load of relevant parts during operation) ;Postoperative investigator satisfaction with the instrument(the feeling of operation);(the operator's operation of the instrument Performance evaluation); | — |
Countries
China
Contacts
Public ContactZhigang Ji
Peking Union Medical College Hospital , Chinese Academy of Medical Sciences
Outcome results
None listed