Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy

Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02398110
• Other study ID #: 20121BBG70032
• Status: Recruiting
• Phase: N/A
• First received: March 10, 2015
• Last updated: August 10, 2015
• Start date: March 2015
• Est. completion date: November 2016

Study information

• Verified date: August 2015
• Source: First Affiliated Hospital of Gannan Medical University
• Contact: Xiaofeng Zou, MD
• Phone: +86-797-8269588
• Email: gyfyurology[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Disease

Intervention

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
• 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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Gannan Medical University	Ganzhou	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Gannan Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Intraoperative complications (e.g. bleeding, organ-injury)	e.g. bleeding, organ-injury	Evaluated at the operation day	Yes
Secondary	Duration of the operation	in minutes	at the operation day	No
Secondary	Quality of life (SF-36)	measured with the	on postoperative month 1	No
Secondary	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)	No