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Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy

Primary Purpose

Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transvaginal NOTES nephrectomy
conventional laparoscopic nephrectomy
Sponsored by
First Affiliated Hospital of Gannan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • First Affiliated Hospital of Gannan Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

transvaginal NOTES nephrectomy

conventional laparoscopic nephrectomy

Arm Description

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

Outcomes

Primary Outcome Measures

Intensity of pain in motion (Pain Scores on the Visual Analog Scale (0-10)
Pain Scores on the Visual Analog Scale (0-10)

Secondary Outcome Measures

Cosmetic assessment (Patient Scar Assessment Questionnaire)
The cosmetic result was assessed using a Patient Scar Assessment Questionnaire and Scoring System (PSAQ)
Sexual function (Female Sexual Function Index)
Sexual function was evaluated according to the Female Sexual Function Index
Intraoperative complications (e.g. bleeding, organ-injury)
e.g. bleeding, organ-injury
Duration of the operation
in minutes
Quality of life (SF-36)
measured with the
Postoperative complication (classified using the Clavien-Dindo system)
Early (≤ 1 month) and late (> 1 month) complications were classified using the Clavien-Dindo system

Full Information

First Posted
March 10, 2015
Last Updated
August 10, 2015
Sponsor
First Affiliated Hospital of Gannan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02398110
Brief Title
Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy
Official Title
Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Gannan Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transvaginal NOTES nephrectomy
Arm Type
Experimental
Arm Description
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
Arm Title
conventional laparoscopic nephrectomy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
transvaginal NOTES nephrectomy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
conventional laparoscopic nephrectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Intensity of pain in motion (Pain Scores on the Visual Analog Scale (0-10)
Description
Pain Scores on the Visual Analog Scale (0-10)
Time Frame
at postoperative day 1
Secondary Outcome Measure Information:
Title
Cosmetic assessment (Patient Scar Assessment Questionnaire)
Description
The cosmetic result was assessed using a Patient Scar Assessment Questionnaire and Scoring System (PSAQ)
Time Frame
> 3 months after surgery
Title
Sexual function (Female Sexual Function Index)
Description
Sexual function was evaluated according to the Female Sexual Function Index
Time Frame
Preoperatively, and 4, 8 and 12 months postoperatively
Title
Intraoperative complications (e.g. bleeding, organ-injury)
Description
e.g. bleeding, organ-injury
Time Frame
Evaluated at the operation day
Title
Duration of the operation
Description
in minutes
Time Frame
at the operation day
Title
Quality of life (SF-36)
Description
measured with the
Time Frame
on postoperative month 1
Title
Postoperative complication (classified using the Clavien-Dindo system)
Description
Early (≤ 1 month) and late (> 1 month) complications were classified using the Clavien-Dindo system
Time Frame
early (≤ 1 month), or late (>1 month)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaofeng Zou, MD
Phone
+86-797-8269588
Email
gyfyurology@126.com
Facility Information:
Facility Name
First Affiliated Hospital of Gannan Medical University
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
341000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zou, MD
Phone
+86-797-8269588
Email
gyfyurology@126.com

12. IPD Sharing Statement

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Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy

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