A Prospective Randomized Controlled Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Kidney Specimen (STTELS)
试验速览
- 阶段
- 不适用
- 入组人数
- 106
- 主要终点
- Patient and Observer Scar Assessment Scale (POSAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient and Observer Scar Assessment Scale (POSAS)
时间窗: 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?
次要结局
- Post-op pain assessment(post-op 48hrs)
- Vaginal wound assessment(post-op 8 weeks)
- Female Sexual Function Index (FSFI) questionnaire(post-op 5 months)