Urologic Neoplasms
Conditions
Keywords
natural orifice specimen extraction, laparoscopic surgery, transvaginal, female
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.
Interventions
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
PROCEDURETransabdominal 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
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Intervention model description
Transvaginal specimen extraction vs Transabdominal specimen extraction
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Vaginal wound assessment | post-op 1 week | assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain |
| Post-op pain assessment | post-op 2hrs | Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10) |
| 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 |
Outcome results
None listed