Clinical trial NCT05135520: Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen
Official title: A Prospective Randomized Controlled Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen (STTELS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urologic Neoplasms
Keywords: natural orifice specimen extraction
laparoscopic surgery
transvaginal
female
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 106
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Transvaginal specimen extraction vs Transabdominal specimen extraction
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: post-op 1 week
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: post-op 8 weeks
Secondary outcomes:
measure: Vaginal wound assessment
timeFrame: post-op 1 week
measure: Vaginal wound assessment
timeFrame: post-op 8 weeks
measure: Post-op pain assessment
timeFrame: post-op 2hrs
measure: Post-op pain assessment
timeFrame: post-op 6hrs
measure: Post-op pain assessment
timeFrame: post-op 24hrs
measure: Post-op pain assessment
timeFrame: post-op 48hrs
measure: Female Sexual Function Index (FSFI) questionnaire
timeFrame: post-op 5 months
Other outcomes:
Locations:
Study officials:
References: