Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy

First Affiliated Hospital of Gannan Medical University

Status: Unknown

Conditions: Renal Disease

Treatments: Procedure: conventional laparoscopic nephrectomy; Procedure: transvaginal NOTES nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02398110

20121BBG70032

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

transvaginal NOTES nephrectomy

Experimental group

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

Treatment:

Procedure: transvaginal NOTES nephrectomy

Procedure: conventional laparoscopic nephrectomy

conventional laparoscopic nephrectomy

Active Comparator group

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

Treatment:

Procedure: transvaginal NOTES nephrectomy

Procedure: conventional laparoscopic nephrectomy