A Prospective Randomized Controlled Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen (STTELS)
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 106
- Primary Endpoint
- Patient and Observer Scar Assessment Scale (POSAS)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Transabdominal specimen extraction
The outcomes of transabdominal specimen extraction in a classic way in patients who underwent multiport laparoscopic surgery for resection of kidney
Intervention: Transabdominal specimen extraction (Procedure)
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
Intervention: Transvaginal natural orifice specimen extraction (NOSE) (Procedure)
Outcomes
Primary Outcomes
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: 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?
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: post-op 1 week
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 Outcomes
- Post-op pain assessment(post-op 48hrs)
- Vaginal wound assessment(post-op 8 weeks)
- Female Sexual Function Index (FSFI) questionnaire(post-op 5 months)
- Vaginal wound assessment(post-op 1 week)
- Post-op pain assessment(post-op 2hrs)
- Post-op pain assessment(post-op 6hrs)
- Post-op pain assessment(post-op 24hrs)