Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy

Study Overview
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Brief Summary
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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.

Official Title
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Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy: a Randomized Clinical Trial

Conditions
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Renal Disease

Intervention / Treatment
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* Procedure: transvaginal NOTES nephrectomy
* Procedure: conventional laparoscopic nephrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transvaginal NOTES nephrectomy<br>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 | Procedure: transvaginal NOTES nephrectomy<br>* 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<br>Procedure: conventional laparoscopic nephrectomy<br>* 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<br>|
| Active Comparator: conventional laparoscopic nephrectomy<br>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 | Procedure: transvaginal NOTES nephrectomy<br>* 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<br>Procedure: conventional laparoscopic nephrectomy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain in motion (Pain Scores on the Visual Analog Scale (0-10) | Pain Scores on the Visual Analog Scale (0-10) | at postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic assessment (Patient Scar Assessment Questionnaire) | The cosmetic result was assessed using a Patient Scar Assessment Questionnaire and Scoring System (PSAQ) | > 3 months after surgery | 
| Sexual function (Female Sexual Function Index) | Sexual function was evaluated according to the Female Sexual Function Index | Preoperatively, and 4, 8 and 12 months postoperatively | 
| Intraoperative complications (e.g. bleeding, organ-injury) | e.g. bleeding, organ-injury | Evaluated at the operation day | 
| Duration of the operation | in minutes | at the operation day | 
| Quality of life (SF-36) | measured with the | on postoperative month 1 | 
| Postoperative complication (classified using the Clavien-Dindo system) | Early (≤ 1 month) and late (> 1 month) complications were classified using the Clavien-Dindo system | early (≤ 1 month), or late (>1 month) |