NCT05135520 - Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen | Crick

Overview

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 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

106

Conditions

Urologic Neoplasms

Interventions

Transvaginal natural orifice specimen extraction (NOSE)PROCEDURE

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

Transabdominal specimen extractionPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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?

Time frame: 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?

Time frame: post-op 8 weeks

Secondary Outcomes

Vaginal wound assessment

assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain

Time frame: post-op 1 week

Vaginal wound assessment

assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain