Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen
A Prospective Randomized Controlled Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen (STTELS)
1 other identifier
interventional
106
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 26, 2021
CompletedStudy Start
First participant enrolled
November 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2023
CompletedNovember 26, 2021
November 1, 2021
1 year
November 4, 2021
November 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (7)
Vaginal wound assessment
post-op 1 week
Vaginal wound assessment
post-op 8 weeks
Post-op pain assessment
post-op 2hrs
Post-op pain assessment
post-op 6hrs
Post-op pain assessment
post-op 24hrs
- +2 more secondary outcomes
Study Arms (2)
Transabdominal specimen extraction
ACTIVE COMPARATORThe 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)
EXPERIMENTALThe outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who underwent multiport laparoscopic surgery for resection of kidney
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
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2021
First Posted
November 26, 2021
Study Start
November 29, 2021
Primary Completion
November 29, 2022
Study Completion
November 29, 2023
Last Updated
November 26, 2021
Record last verified: 2021-11