Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedAugust 13, 2015
August 1, 2015
1.5 years
March 10, 2015
August 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Cosmetic assessment (Patient Scar Assessment Questionnaire)
> 3 months after surgery
Sexual function (Female Sexual Function Index)
Preoperatively, and 4, 8 and 12 months postoperatively
Intraoperative complications (e.g. bleeding, organ-injury)
Evaluated at the operation day
Duration of the operation
at the operation day
Quality of life (SF-36)
on postoperative month 1
- +1 more secondary outcomes
Study Arms (2)
transvaginal NOTES nephrectomy
EXPERIMENTALA 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
ACTIVE COMPARATOROne 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
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
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
You may qualify if:
- female sex,
- indication for nephrectomy due to benign or malignant kidney disease,
- age between 18 and 65 years, and
- legal competence
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
March 10, 2015
First Posted
March 25, 2015
Study Start
March 1, 2015
Primary Completion
September 1, 2016
Study Completion
November 1, 2016
Last Updated
August 13, 2015
Record last verified: 2015-08