Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen
NCT ID: NCT05135520
Last Updated: 2021-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
106 participants
INTERVENTIONAL
2021-11-29
2023-11-29
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Transabdominal specimen extraction
The outcomes of transabdominal specimen extraction in a classic way in patients who underwent multiport laparoscopic surgery for resection of kidney
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
FEMALE
Yes
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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SNUBH B-2105-687-003
Identifier Type: -
Identifier Source: org_study_id