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临床试验/NCT04037813
NCT04037813已完成不适用

Comparative Study of Hysteroscopic Versus Laparoscopic Tubal Occlusion in Cases of Communicating Hydrosalpinx and Planning for IVF

Cairo University2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2019年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
2
主要终点
The percentage of patients with successful hysteroscopic tubal occlusion

研究概览

简要总结

compare the efficacy of hysteroscopic tubal occlusion versus laparoscopic tubal occlusion for the patients of communicating hydrosalpinx scheduled for IVF. half of the patients will undergo hysteroscopic tubal occlusion while the other half will undergo laparoscopic tubal occlusion.

详细描述

The study will include 108 patients complaining of infertility associated with unilateral or bilateral tubal communicating hydrosalpinx. All the patients will be subjected to informed consent, history taking, full physical examination, ultrasound examination via transvaginal approach using ultrasound machine ( Voluson Pro-V and GE Voluson E 10) and HSG within the last 6 months showing unilateral or bilateral communicating hydrosalpinx.

The patients (108) will be equally randomized into two groups :

Group (A): 54 patients (Hysteroscopic tubal occlusion group). Group (B): 54 patients (Laparoscopic tubal occlusion group). Randomization will be done using 108 opaque sealed envelopes that will be numbered serially from 1-108 and each envelope corresponding letter which denotes the allocated group will be put according to randomization table then all envelopes will be closed and put in one box, when the first patient arrives, after giving informed consent, the first envelope will be opened and the patient will be allocated according to the letter inside.

For hysteroscopic tubal occlusion group it will be done under general anesthesia using standard, rigid 4-mm hysteroscopy with a 30° forward-oblique lens and a 5.5-mm diagnostic sheath (Karl Storz , Germany). Uterine distension allowed a panoramic view of the uterine cavity and identification of the tubal ostia.The roller ball (Ball Electrode, unipolar, 5 Fr) will be used for the coagulation of the interstitial part of the tube and the uterine cornu area.

For laparoscopic tubal occlusion group it will be done under general anesthesia using bipolar coagulation and a proximal tubal cut. The contraindications for laparoscopy were mainly extensive abdominal or pelvic adhesions of various etiologies (e.g. previous surgery, pelvic inflammatory disease, and pelvic endometriosis) and morbid obesity.

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
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Primary or secondary infertility.
  • The presence of communicating hydrosalpinx diagnosed by HSG,TV U/S showing distended tubes and intrauterine fluid or patient complaining of prolonged brownish vaginal discharge.
  • Candidate for IVF procedure.

排除标准

  • Uterine anomalies.
  • Serious medical condition and unfit for surgery.
  • Contraindication for laparoscopic tubal occlusion.
  • Contraindication for pregnancy.

结局指标

主要结局

The percentage of patients with successful hysteroscopic tubal occlusion

时间窗: one month post-operative.

Successful tubal occlusion will be measured by the presence of negative spill and proximal tubal block on HSG.

次要结局

  • The post-operative pain in both groups (using VAS ).(24 hours post-operative.)
  • The percentage of patients with successful laparoscopic tubal occlusion(one month post-operative.)
  • Compare the success rate of tubal occlusion in both groups.(one month post-operative.)
  • The operative time and complications in both groups.(Intra-operative duration.)

研究者

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

Mahmoud Ahmed Abdel Salam

Assistant lecturer in obstetrics and gynecology department

Cairo University

研究点 (2)

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