Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urologic Neoplasms
• Intervention / Treatment: Procedure: Transabdominal specimen extraction; Procedure: Transvaginal natural orifice specimen extraction (NOSE)

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 Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transabdominal specimen extraction; The outcomes of transabdominal specimen extraction in a classic way in patients who underwent multiport laparoscopic surgery for resection of kidney	Procedure: Transabdominal specimen extraction; Under general anesthesia, patients who are planned to perform multiport laparoscopic surgery for resection of solid organs including kidney or bladder will undergo transabdominal specimen extraction with incision elongation
Experimental: 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	Procedure: Transvaginal natural orifice specimen extraction (NOSE); Under general anesthesia, patients who are planned to perform multiport laparoscopic surgery for resection of solid organs including kidney or bladder will undergo Transvaginal NOSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and Observer Scar Assessment Scale (POSAS)	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?	post-op 1 week
Patient and Observer Scar Assessment Scale (POSAS)	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?	post-op 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal wound assessment	assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain	post-op 1 week
Vaginal wound assessment	assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain	post-op 8 weeks
Post-op pain assessment	Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)	post-op 2hrs
Post-op pain assessment	Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)	post-op 6hrs
Post-op pain assessment	Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)	post-op 24hrs
Post-op pain assessment	Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)	post-op 48hrs
Female Sexual Function Index (FSFI) questionnaire	Assessment Domain: Desire/ Arousal/ Lubrication/ Orgasm/ Satisfaction/ Pain Full scale score range: min 2.0 - max 36	post-op 5 months

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 29, 2021
• Primary Completion (Anticipated): November 29, 2022
• Study Completion (Anticipated): November 29, 2023

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: laparoscopic surgery; female; natural orifice specimen extraction; transvaginal
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Neoplasms
• Other Study ID Numbers: SNUBH B-2105-687-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No