Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen

Not Applicable

• Conditions: Urologic Neoplasms
• Interventions: Procedure: Transabdominal specimen extraction; Procedure: Transvaginal natural orifice specimen extraction (NOSE)

• Registration Number: NCT05135520
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Study First Posted: 2021-11-26
• Last Update Posted: 2021-11-26
• Study Start: 2021-11-29
• Primary Completion: 2022-11-29
• Study Completion: 2023-11-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transabdominal specimen extraction	Transabdominal specimen extraction	The outcomes of transabdominal specimen extraction in a classic way in patients who underwent multiport laparoscopic surgery for resection of kidney
Transvaginal natural orifice specimen extraction (NOSE)	Transvaginal natural orifice specimen extraction (NOSE)	The outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who underwent multiport laparoscopic surgery for resection of kidney

Primary Outcome Measures

Name	Time	Method
Patient and Observer Scar Assessment Scale (POSAS)	post-op 8 weeks	Cosmetic outcomes of scar assessed by Patient and Observer Scar Assessment Scale (POSAS) 1 week and 8 weeks after surgery. The POSAS is the international validated scar assessment questionnaire that measures quality of the scar from the perspective of both patient and observer.; observer scar assessment scale (OSAS): good (1) - bad (10); - vascularization/ pigmentation/ thickness/ relief/ pliability; patient scar assessment scale (PSAS): No (1) - Yes (10); * Is the scar painful?; * Is the scar itching?; * Is the scar color different from the color of your normal skin?; * Is the stiffness of the scar different from the color of your normal skin?; * Is the thickness of the scar different from the color of your normal skin?; * Is the scar more irregular than your normal skin?

Secondary Outcome Measures

Name	Time	Method
Post-op pain assessment	post-op 48hrs	Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)
Vaginal wound assessment	post-op 8 weeks	assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain
Female Sexual Function Index (FSFI) questionnaire	post-op 5 months	Assessment Domain: Desire/ Arousal/ Lubrication/ Orgasm/ Satisfaction/ Pain Full scale score range: min 2.0 - max 36