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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05135520
Other study ID # SNUBH B-2105-687-003
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 29, 2021
Est. completion date November 29, 2023

Study information

Verified date November 2021
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 106
Est. completion date November 29, 2023
Est. primary completion date November 29, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Vaginal wound assessment assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain post-op 1 week
Secondary Vaginal wound assessment assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain post-op 8 weeks
Secondary Post-op pain assessment Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10) post-op 2hrs
Secondary Post-op pain assessment Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10) post-op 6hrs
Secondary Post-op pain assessment Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10) post-op 24hrs
Secondary Post-op pain assessment Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10) post-op 48hrs
Secondary 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
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