Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen

Urologic Neoplasms Clinical Trial

Official title: A Prospective Randomized Controlled Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen (STTELS)

Status Not yet recruiting

Clinical Trial Summary

The aim of this study is to evaluate the outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who are planning multiport laparoscopic surgery for resection of kidney.

Clinical Trial Description

Study design:

This is a prospective, randomized, single center trial. This clinical trial was approved by the Institutional Review Boards.

Study process:

All patients gave informed written consent after being informed of the details of the study. Subjects were randomized into either the experimental group (specimen removal through posterior vagina fornix incision) or control groups (specimen removal through extended abdominal incision). All participants underwent demographic and history taking, laboratory tests, a gynecologic examination to determine whether specimen removal through vagina is possible.

To evaluate cosmesis, patient satisfaction and quality of life VAS (Visual Analogue Scale), SF-12 (Short Form-12) health survey, BIQ (Body Image Questionnaire) and POSAS (the Patient and Observer Scar Assessment Scale) will be sent to the patients 6 months after the surgery. ;

Related Conditions & MeSH terms

• Urologic Neoplasms

• NCT number: NCT05135520
• Study type: Interventional
• Source: Seoul National University Bundang Hospital
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 29, 2021
• Completion date: November 29, 2023