Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy

NCT ID: NCT02398110

Last Updated: 2015-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

transvaginal NOTES nephrectomy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

transvaginal NOTES nephrectomy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Gannan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiaofeng Zou

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaofeng Zou, MD

Role: CONTACT

+86-797-8269588

Facility Contacts

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Xiaofeng Zou, MD

Role: primary

+86-797-8269588

Other Identifiers

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20121BBG70032

Identifier Type: -

Identifier Source: org_study_id

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