Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen

Seoul National University

Status: Unknown

Conditions: Urologic Neoplasms

Treatments: Procedure: Transabdominal specimen extraction; Procedure: Transvaginal natural orifice specimen extraction (NOSE)

Study type: Interventional

Funder types: Other

Identifiers

NCT05135520

SNUBH B-2105-687-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who are accessible with vaginal approach
• Patients scheduled for laparoscopic resection of kidney for benign or malignant diseases
• Patients with normal cervical cancer screening tests within the last 3 years except inflammatory findings

Exclusion criteria

• Patients without sexual intercourse
• Patients who are considered unable to remove specimen through vagina due to narrow introitus in gynecological examination
• Patients who are expected to have severe adhesion due to deep infiltrative endometriosis or previous pelvic surgery history
• Patients with abnormal cervical cancer screening tests
• Patients scheduled to perform concomitant hysterectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

106 participants in 2 patient groups

Transabdominal specimen extraction

Active Comparator group

Description:

The outcomes of transabdominal specimen extraction in a classic way in patients who underwent multiport laparoscopic surgery for resection of kidney

Treatment:

Procedure: Transabdominal specimen extraction

Transvaginal natural orifice specimen extraction (NOSE)

Experimental group

Description:

The outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who underwent multiport laparoscopic surgery for resection of kidney

Treatment:

Procedure: Transvaginal natural orifice specimen extraction (NOSE)