Renal Disease
Conditions
Brief summary
Recent reports have suggested that transvaginal NOTES nephrectomy is feasible, yet comparative studies are lacking. The aim of this study was to compare the surgical outcomes of transvaginal NOTES nephrectomy to conventional laparoscopic nephrectomy.
Interventions
PROCEDUREtransvaginal NOTES nephrectomy
A 5- and 10-mm trocar were placed at the right and left medial margin of umbilicus. A lengthened 10-mm trocar was placed through the vagina into the abdominal cavity
PROCEDUREconventional laparoscopic nephrectomy
One 10-mm trocar was inserted at the midclavicular line 2 cm below the umbilicus, another 10-mm periumbilical trocar was placed for the camera, and a 5- or 10-mm trocar was placed 3 cm below the costal margin
Sponsors
First Affiliated Hospital of Gannan Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* female sex, * indication for nephrectomy due to benign or malignant kidney disease, * age between 18 and 65 years, and * legal competence
Exclusion criteria
* emergency surgery, * contraindications to laparoscopic surgery, * class IV or V as defined by the American Society for Anesthesiologists (ASA), * body mass index (BMI) of \> 30 kg/m2, * advanced TNM staging (≥ T3), * history of major abdominal surgery, * gravidity or breast-feeding, and * no written informed consent signed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of pain in motion (Pain Scores on the Visual Analog Scale (0-10) | at postoperative day 1 | Pain Scores on the Visual Analog Scale (0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual function (Female Sexual Function Index) | Preoperatively, and 4, 8 and 12 months postoperatively | Sexual function was evaluated according to the Female Sexual Function Index |
| Intraoperative complications (e.g. bleeding, organ-injury) | Evaluated at the operation day | e.g. bleeding, organ-injury |
| Cosmetic assessment (Patient Scar Assessment Questionnaire) | > 3 months after surgery | The cosmetic result was assessed using a Patient Scar Assessment Questionnaire and Scoring System (PSAQ) |
| Quality of life (SF-36) | on postoperative month 1 | measured with the |
| Postoperative complication (classified using the Clavien-Dindo system) | early (≤ 1 month), or late (>1 month) | Early (≤ 1 month) and late (\> 1 month) complications were classified using the Clavien-Dindo system |
| Duration of the operation | at the operation day | in minutes |
Countries
China
Contacts
Primary ContactXiaofeng Zou, MD
Outcome results
None listed