Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer: a Pilot Study
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Frequency of pelvic lymphocele
研究概览
简要总结
Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies.
Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment.
A number of surgical techniques have developed, but failed to reduce the incidence of pelvic lymphoceles after PLND.
The investigators hypothesized that floseal can prevent lymphoceles in patients with gynecologic cancer who has undergone PLND.
The investigators designed prospective randomized controlled study as a pilot study.
The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and observe the occurence of pelvic lymphoceles after 6 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gynecologic cancer patients who need laparotomic bilateral PLND
排除标准
- •Incomplete PLND which can influence the occurrence of lymphocele (surgeon's decision)
研究组 & 干预措施
Floseal
application of floseal to one side of pelvis after pelvic lymphadenectomy
干预措施: Floseal (Drug)
结局指标
主要结局
Frequency of pelvic lymphocele
时间窗: 6 month
Frequency of ipsilateral pelvic lymphocele at post-operative 6th month.
次要结局
- Post-operative drainage(post-operative 3 days)
- lymphedema(post-operative 3 and 6 month)
研究者
Yun Hwan KIM
Assistant Professor
Ewha Womans University Mokdong Hospital