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临床试验/NCT06554964
NCT06554964尚未招募不适用

Feasibility, Safety and Effectiveness of Chromotubation on the Remaining Fallopian Tube After a Laparoscopic Salpingectomy Due to Tubal Pregnancy

Assaf-Harofeh Medical Center0 个研究点目标入组 100 人开始时间: 2024年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Precentage of successful chromotubation (passing of blue dye through the fallopian tube) during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy.

研究概览

简要总结

Ectopic pregnancy prevalence is approximately 1-2% of all pregnancies, majority of which located in the fallopian tube. Among the risk factors for ectopic pregnancy is tubal factor - meaning a mechanical problem within the fallopian tube resulting in the pregnancy remaining in the fallopian tube. The treatment o tubal pregnancy can be expectant, medical via metotrexate or surgicl via laparoscopic salpingectomy of the involved fallopian tube. The purpose of this study is to assess the feasibility of chromotubation during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy hence assessing the function of the remaining fallopian tube and trying to predict future fertility for the patient.

详细描述

Ectopic pregnancy occurs approximately in 1-2% of all pregnancies. The risk is higher among patients with risk factors such as previous ectopic pregnancy, history of pelvic inflammatory disease, endometriosis, past tubal surgery, pregnancy following in vitro fertilization, and pregnancy conceived with an intrauterine device. In 97% of the cases the location of the ectopic pregnancy would be in the fallopian tube. The management of fallopian tube ectopic pregnancy can be expectant, medical (with intramuscular methotrexate) or surgical via laparoscopic salpingectomy of the involved fallopian tube. The optimal management is chosen depending on the clinical presentation, sonographic and laboratory findings and patient's wishes.

Laparoscopic salpingectomy is indicated in cases of suspected ruptured ectopic pregnancy. Salpingectomy is also offered in cases of recurrent ipsilateral ectopic pregnancy, contraindications to medical management with methotrexate, and patients who prefer surgical over medical treatment.

The risk of recurrent ectopic tubal pregnancy following unilateral laparoscopic salpingectomy varies according to the functionality of the remaining fallopian tube and between different studies. In cases of an abnormal contralateral fallopian tube, the risk of recurrent tubal pregnancy is high. For patients with a healthy contralateral fallopian tube some studies found that the long-term fertility after salpingectomy was not significantly impacted, while other studies reported a mild reduction in natural conception rates. Thus, it is estimated that a functional remaining fallopian tube may capture oocytes from both ovaries, and may compensate for the loss of the other fallopian tube. Overall, the patency and functionality of the remaining fallopian tube is the most important factor in determining the risk of recurrent ectopic pregnancy and the rates of subsequent natural intrauterine conception.

Chromotubation is a procedure used in order to assess the patency of the fallopian tubes, mostly at time of laparoscopy under general anesthesia. It involves the injection of colored blue dye (mostly methylene blue or indigo carmine) through the cervix and into the uterine cavity and the fallopian tubes. During laparoscopy, the flow of the dye through the fallopian tubes may be observed, and the patency of the fallopian tubes may be determined.

The intracervical use of methylene blue or indigo-carmine for laparoscopic chromotubation is generally considered safe. Rare adverse reactions were described among patients with G6PD deficiency for whom methylene blue may cause hemolysis and for patient who are treated with SSRI for whom methylene blue may cause serotonin toxicity due to inhibition of monoamine oxidase.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy.

排除标准

  • Patients with a history of unilateral salpingectomy
  • Patients with suspected heterotopic pregnancy
  • Patients with suspected allergic reaction to blue dye injection

结局指标

主要结局

Precentage of successful chromotubation (passing of blue dye through the fallopian tube) during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy.

时间窗: 1 year

How many cases would demonstrate patent fallopian tube via blue dye injected verses how many occluded ones.

次要结局

  • Percentage of adverse reaction to chromotubation during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy.(1 year)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Neta Eisenberg Kogan

Attending physician in the gynecology endoscopy unit

Assaf-Harofeh Medical Center

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