A Prospective Clinical Study of Transvaginal Versus Transabdominal Extraction of Laparoscopically-excised Specimen (STTELS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 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 solid organs including kidney, liver, stomach, adrenal gland and bladder.
详细描述
Study design:
This was a prospective, single center, single arm study. 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. All participants underwent demographic and history taking, laboratory tests and a gynecological examination to determine whether specimen removal through vagina is possible. The patients who was adequate for this study were planned to perform multiport laparoscopic surgery and patients were subjected to transvaginal NOSE.
To perform transvaginal NOSE procedure, the patients were placed in the lithotomy position with Trendelenburg position. After about 1-2cm incision at the posterior vaginal fornix, endopouch was introduced into the abdominal cavity through vaginal incision site. The specimen was placed inside a endopouch and removed through vagina. Closure of vaginal incision site was achieved by transvaginally with 2/0 absorbable suture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 stomach, colon, kidney and spleen 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: 8 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.
次要结局
- Female Sexual Function Index (FSFI) questionnaire(6 months)