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Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy

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ClinicalTrials.gov Identifier: NCT02398110
Recruitment Status : Unknown
Verified August 2015 by Xiaofeng Zou, First Affiliated Hospital of Gannan Medical University.
Recruitment status was:  Recruiting
First Posted : March 25, 2015
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Xiaofeng Zou, First Affiliated Hospital of Gannan Medical University

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.

Condition or disease Intervention/treatment Phase
Renal Disease Procedure: transvaginal NOTES nephrectomy Procedure: conventional laparoscopic nephrectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy: a Randomized Clinical Trial
Study Start Date : March 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: 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
Procedure: 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

Procedure: 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

Active Comparator: 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
Procedure: 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

Procedure: 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




Primary Outcome Measures :
  1. Intensity of pain in motion (Pain Scores on the Visual Analog Scale (0-10) [ Time Frame: at postoperative day 1 ]
    Pain Scores on the Visual Analog Scale (0-10)


Secondary Outcome Measures :
  1. Cosmetic assessment (Patient Scar Assessment Questionnaire) [ Time Frame: > 3 months after surgery ]
    The cosmetic result was assessed using a Patient Scar Assessment Questionnaire and Scoring System (PSAQ)

  2. Sexual function (Female Sexual Function Index) [ Time Frame: Preoperatively, and 4, 8 and 12 months postoperatively ]
    Sexual function was evaluated according to the Female Sexual Function Index

  3. Intraoperative complications (e.g. bleeding, organ-injury) [ Time Frame: Evaluated at the operation day ]
    e.g. bleeding, organ-injury

  4. Duration of the operation [ Time Frame: at the operation day ]
    in minutes

  5. Quality of life (SF-36) [ Time Frame: on postoperative month 1 ]
    measured with the

  6. Postoperative complication (classified using the Clavien-Dindo system) [ Time Frame: early (≤ 1 month), or late (>1 month) ]
    Early (≤ 1 month) and late (> 1 month) complications were classified using the Clavien-Dindo system



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398110


Contacts
Contact: Xiaofeng Zou, MD +86-797-8269588 gyfyurology@126.com

Locations
China, Jiangxi
First Affiliated Hospital of Gannan Medical University Recruiting
Ganzhou, Jiangxi, China, 341000
Contact: Xiaofeng Zou, MD    +86-797-8269588    gyfyurology@126.com   
Sponsors and Collaborators
First Affiliated Hospital of Gannan Medical University

Responsible Party: Xiaofeng Zou, professor, First Affiliated Hospital of Gannan Medical University
ClinicalTrials.gov Identifier: NCT02398110     History of Changes
Other Study ID Numbers: 20121BBG70032
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015