Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy
NCT ID: NCT02398110
Last Updated: 2015-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-03-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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transvaginal 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
transvaginal 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
conventional 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
conventional 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
transvaginal 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
conventional 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
Interventions
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transvaginal 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
conventional 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
Eligibility Criteria
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Inclusion Criteria
* indication for nephrectomy due to benign or malignant kidney disease,
* age between 18 and 65 years, and
* legal competence
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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First Affiliated Hospital of Gannan Medical University
OTHER
Responsible Party
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Xiaofeng Zou
professor
Locations
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First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20121BBG70032
Identifier Type: -
Identifier Source: org_study_id
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