Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Renal Disease
• Intervention / Treatment: Procedure: transvaginal NOTES nephrectomy; Procedure: conventional laparoscopic nephrectomy

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341000
      • Recruiting
      • First Affiliated hospital of Gannan Medical University
      • Contact: Xiaofeng Zou, MD; Phone Number: +86-797-8269588; Email: gyfyurology@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Gannan Medical University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: March 10, 2015
• First Submitted That Met QC Criteria: March 19, 2015
• First Posted (Estimate): March 25, 2015

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: 20121BBG70032