Fallopian Tube Occlusion
Conditions
Brief summary
Is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of women, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF and in tubal sterilization.
Detailed description
The study will be conducted according to the guidelines on human experimentation of the 1975 Declaration of Helsinki. For all patients after taking signed informed consent , transcervical hysteroscopic cannulation of the proximal one centimeter of both fallopian tubes, will be done using a 5 Fr, 42cm long, polyethylene ureteric catheter, where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected in each side. All the surgical procedures will be performed without anesthesia, only premedication with an NSAID (e.g. NaproxenR) is given orally one hour before the procedure. Each patient will be under close observation for the first 24 hours postprocedure for any signs of inflammation as abdominal pain, tenderness or fever and for the vital data. Total abdominal hysterectomy and bilateral salpingoophorectomy will be done, second day, a week, two weeks and three weeks and four weeks after injection,. Hysterectomy samples will be sent to histopathologist to assess the degree of tubal occlusion and the extent and the severity of inflammation in the tubal wall.
Interventions
DRUGIsoamyl-2-cyanoacrylate
Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter
Sponsors
Ain Shams University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* patients planned for abdominal hysterectomy with well seen tubal ostia through hysteroscope
Exclusion criteria
* Any patient with Upper or lower genital tract infection as evidenced by fever, lower abdominal pain or tenderness and abnormal vaginal discharge will be excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fallopian tube obstruction | from one day to four weeks | assessed by failure of passage of methylene blue through fallopian tubes after injecting it transcervical in the hysterectomy spacements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| degree and extend of inflammation in the fallopian tubes | from one day to four weeks | assessments of this outcome will be done by histopathological examination for severity of inflammatory cellular changes and extend of these inflammatory changes through different layers of the wall of the fallopian tubes |
Countries
Egypt
Contacts
Primary ContactMohamed I Amer, MD
Outcome results
None listed