Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen

Urologic Neoplasms Clinical Trial

Official title:

A Prospective Randomized Controlled Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen (STTELS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05135520
• Other study ID #: SNUBH B-2105-687-003
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Urologic Neoplasms

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