直肠剃毛术治疗深部直肠阴道子宫内膜异位症结节后血管形成的评估 (INDIE)
使用吲哚菁绿注射液直肠剃毛治疗深部直肠阴道子宫内膜异位结节后血管形成的估计。可行性研究
Indocyanine green is a dye, using in surgery to bring out the intraoperative evaluation of tissue perfusion.
After intravenous injection of indocyanine green, using a near infrared light, the vascularisation becomes fluorescent.
In endometriosis disease, the treatment of recto vaginal node can be complicated by rectovaginal fistula.
An abnormal vascularisation related to the surgery would be a risk factor of post operative fistulas.
The aim of this study is to evaluate the rectal and vaginal vascularisation during the treatment of a recto vaginal endometriosis nodule with rectal shaving, using indocyanine green fluorescence.
研究概览
详细说明
Investigators are going to inject, at the end of a rectal shaving, a bolus of 0,2mg/kg of indocyanine green after dilution (2,5mg/ml). With de SPIES system (KARL STORZ GmbH & Co. KG, Tuttlingen, Germany), the vascularisation would be imediately fluorescent. Investigators are going to estimate the vascularization of the rectal serosa and mucosa where the nodule was located.
If a vaginal resection has been performed, investigators are going to estimate the vascularization of the vaginal scar.
To estimate de vascularization, investigators are going tu use a scale with a score between 0 and 4.
After the surgery, the post-operative follow-up with be the same as usual after a Rectal Shaving.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
-
Clermont-Ferrand、法国、63003
- CHU Clermont-Ferrand
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients above the age of 18 year
- Patients with endometriosis recto vaginal node
- Patients with operative indications of rectal shaving, with or without vaginal resection
- Patients who have accepted to participate
Exclusion Criteria:
- minors patients
- Patients under guardianship or wardship
- Patients who refused the participation
- Iodine allergy
- Pregnant woman
- Patients during lactation
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：子宫内膜异位症阴道直肠淋巴结
|
Use of Indocyanine Green during Rectal shaving by laparoscopy. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Per-operative evaluation of the rectum
大体时间：at day 1
|
Per-operative evaluation of the rectum after Shaving, using indocyanine green fluorescence, by transperitoneal and intra-rectal approach, and vaginal suture if there is an associated vaginal resection. A fluorescence score between 0 and 4 will be used, based on a Likert scale |
at day 1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
注射吲哚菁绿后的副作用
大体时间：在第 1 天
|
在第 1 天
|
|
|
Post operative complications
大体时间：at day 1
|
infections, abdominal abscess, abdominal hematoma, post operative fistula. |
at day 1
|
合作者和调查者
调查人员
- 首席研究员：Nicolas BOURDEL、University Hospital, Clermont-Ferrand
出版物和有用的链接
一般刊物
- Bar-Shavit Y, Jaillet L, Chauvet P, Canis M, Bourdel N. Use of indocyanine green in endometriosis surgery. Fertil Steril. 2018 Jun;109(6):1136-1137. doi: 10.1016/j.fertnstert.2018.02.113. Epub 2018 Jun 6.
- Bourdel N, Jaillet L, Bar-Shavit Y, Comptour A, Pereira B, Canis M, Chauvet P. Indocyanine green in deep infiltrating endometriosis: a preliminary feasibility study to examine vascularization after rectal shaving. Fertil Steril. 2020 Aug;114(2):367-373. doi: 10.1016/j.fertnstert.2020.03.042. Epub 2020 Jul 7.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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