Urologic NeoplasmsNCT05135520
Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen
A study testing Transvaginal natural orifice specimen extraction (NOSE) and Transabdominal specimen extraction in people with Urologic Neoplasms, run by Seoul National University Bundang Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urologic Neoplasms
- What is being tested?
- Transvaginal natural orifice specimen extraction (NOSE) and Transabdominal specimen extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2021to 29 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Prospective Randomized Controlled Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen (STTELS)
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.
Read the 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.
- Conditions
- Urologic Neoplasms
- Being tested
- Transvaginal natural orifice specimen extraction (NOSE), Transabdominal specimen extraction
- Keywords
- natural orifice specimen extraction, laparoscopic surgery, transvaginal, female
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal natural orifice specimen extraction (NOSE)Procedure or surgery
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 extractionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Transabdominal specimen extraction | Active comparator | The outcomes of transabdominal specimen extraction in a classic way in patients who underwent multiport laparoscopic surgery for resection of kidney Receives: Procedure: Transabdominal specimen extraction |
| Transvaginal natural orifice specimen extraction (NOSE) | Experimental | The outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who underwent multiport laparoscopic surgery for resection of kidney Receives: Procedure: Transvaginal natural orifice specimen extraction (NOSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: post-op 1 week
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?
Measured: post-op 8 weeks
Secondary outcomes (7)
Vaginal wound assessment
assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain
Measured: post-op 1 week
Vaginal wound assessment
assessment scale: No (0) - Yes (3) Vaginal bleeding Vaginal discharge Vaginal wound pain
Measured: post-op 8 weeks
Post-op pain assessment
Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)
Measured: post-op 2hrs
Post-op pain assessment
Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)
Measured: post-op 6hrs
Post-op pain assessment
Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)
Measured: post-op 24hrs
Post-op pain assessment
Pain assessment with Visual analogue scale: No pain (0) - Worst pain (10)
Measured: post-op 48hrs
Female Sexual Function Index (FSFI) questionnaire
Assessment Domain: Desire/ Arousal/ Lubrication/ Orgasm/ Satisfaction/ Pain Full scale score range: min 2.0 - max 36
Measured: post-op 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start29 Nov 2021 (estimated)
- Primary completion29 Nov 2022 (estimated)
- Study completion29 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Transvaginal specimen extraction vs Transabdominal specimen extraction
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135520
- Sponsor's protocol ID
- SNUBH B-2105-687-003
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen (STTELS)
- ClinicalTrials.gov ID
- NCT05135520
- Acronym / sponsor ID
- SNUBH B-2105-687-003
- Conditions
- Urologic Neoplasms
- Keywords
- natural orifice specimen extraction, laparoscopic surgery, transvaginal, female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 29 Nov 2021 (estimated)
- Primary completion
- 29 Nov 2022 (estimated)
- Study completion
- 29 Nov 2023 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Transvaginal specimen extraction vs Transabdominal specimen extraction
| Arm | Type | Receives |
|---|---|---|
| Transabdominal specimen extraction | Active comparator | Procedure: Transabdominal specimen extractionThe outcomes of transabdominal specimen extraction in a classic way in patients who underwent multiport laparoscopic surgery for resection of kidney |
| Transvaginal natural orifice specimen extraction (NOSE) | Experimental | 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Transvaginal natural orifice specimen extraction (NOSE) |
| Transabdominal specimen extractionUnder 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 | Procedure or surgery | Transabdominal specimen extraction |
Primary outcome
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?
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?
7 secondary outcomes
Vaginal wound assessment
Time frame: post-op 1 week
Vaginal wound assessment
Time frame: post-op 8 weeks
Post-op pain assessment
Time frame: post-op 2hrs
Post-op pain assessment
Time frame: post-op 6hrs
Post-op pain assessment
Time frame: post-op 24hrs
Post-op pain assessment
Time frame: post-op 48hrs
Female Sexual Function Index (FSFI) questionnaire
Time frame: post-op 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal natural orifice specimen extraction (NOSE) and Transabdominal specimen extraction in people with Urologic Neoplasms, run by Seoul National University Bundang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Observer Scar Assessment Scale (POSAS) (time frame: post-op 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.