Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04367415 |
| Other study ID # |
Darwish test and polyp(s) |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 20, 2021 |
| Est. completion date |
December 26, 2022 |
Study information
| Verified date |
August 2021 |
| Source |
Woman's Health University Hospital, Egypt |
| Contact |
Atef Darwish, MD PhD |
| Phone |
0201001572723 |
| Email |
atef_darwish[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Anatomic Fallopian tubal patency and physiologic patency testing are feasible via
hystertoscopy. This study aims to test the impact of different types of intrauterine polyp(s)
on Darwish test (office hysteroscopic bubble suction test and tubal peristalsis).
Description:
It will include women with suspected intrauterine polyp(s) as diagnosed by transvaginal
ultrasonography (TVS) or saline infusion sonography (SIS). They will be women complaining
from abnormal uterine bleeding in the form of menorrhagia, metorrhagia, intermenstrual
spotting or postcoital bleeding, or infertility. Intrauterine polyp(s) could be included
based on a recent hysterosalpingography (HSG) with an intrauterine circumscribed filling
defect with sharp border. Preoperative counseling of all patients followed by an informed
written consent taken from those who will agree. The included patients subjected to complete
history taking and meticulous physical examination. A suspected pregnancy, heavy vaginal
bleeding, active pelvic inflammatory disease (PID), severe co-morbidity, e.g., severe
cardiac, neurologic, or chest disease, and other medical contraindications to pregnancy will
be exclusion criteria of this study. Selected cases will be subjected to office hysteroscopy.
Sample size calculation is based on the investigator's previous study on the prevalence of
tubal patency using bubble suction test in infertility patients with normal FT. The
percentage of agreement between office hysteroscopy and diagnostic laparoscopy will be 92%
and 88% for the right and left tubes respectively. If it is supposed that bubble suction test
would be positive in about 90% of apparently normal FT and it would be positive in about 60%
of cases with intrauterine polyp(s), sample size in each group would be 51 cases needed to
have a confidence level of 95% with α error of 0.05 (the real value is within ±5% of the
measured/surveyed value). The vulva, vagina and the thighs will be disinfected with a 10%
povidone-iodine solution. Sterile draping will be applied.
Office diagnostic hysteroscopy will be performed using a 2.6 mm 30° rigid scope with a 3.2mm
outer sheath (Karl Storz, Tutlingen, Germany). At the beginning in all cases vaginoscopic
approach is tried but if any difficulty will be encountered, grasping of the anterior lip of
cervix with a volsellum will be done. Therafter, the uterus will be distended with normal
saline at 100-150 mmHg generated from a pneumatic cuff of sphygmomanometer wrapped around the
500-cm3 infusion bottle. As attached to a 250-W Xenon light source, the scope will be
introduced gently through the cervical canal and internal os. To perfectly perform
hysteroscopic tubal patency testing the following tricks should be followed. Clear view of
the endometrial cavity should be achieved on panoramic view by placing the hysteroscope at
internal os waiting for a while to achieve homogenous distension. The uterine cavity should
be systematically examined starting by its anterior and posterior walls, the fundus, and the
borders. Examination will be considered complete if the both tubal ostia will be reached
describing any gross pathology, e.g., septum, adhesions, polyp(s), myoma, and any growth.
If the uterine cavity is normal the patient will be allocated as group A. If there is one or
more polyp(s) the patient will be allocated as group B. Localization and size estimation of
the polyp(s) is mandatory.
Prerequisites for a successful access to evaluate tubal patency include utilization of a 300
telescope with gaining skill of its rotation to reach both cornea and most importantly
orientation with a fundamental anatomic triad (Darwish triad) (DT). The most proximal corneal
fine wide circle is the ostium (the end of the endometrial cavity) representing a base of a
cone which is followed by a shallow conical groove (the first millimeters of the intramural
part of FT). Finally, a distal pinhole dark spot (the narrowest part of the FT) representing
the tip of the cone. Putting DT (ostium, intramural part and dark spot) in mind is the key
step to evaluate tubal patency and physiology via hysteroscopy. If DT is clearly accessible,
the hysteroscopist should comment on this. If there are some osteal lesions like tiny
polyp(s) or fine adhesions that may hinder proper evaluation of the tubal anatomy and
physiology, the hysteroscopist should notice and document. Passage of any air bubbles in the
irrigating fluid towards DT is reported. If no observed air bubbles, the hysteroscopist
should inject just 2 ml of air into the rubber end of the sterile infusion set. Hysteroscopic
bubble suction test is considered positive if air bubbles are sucked by DT within 1 min.
During this period, neither injection of air nor increased pressure will be done. If no
suction of gas bubbles occurred, the examiner should wait for 1 min more to exclude tubal
spasm. Again, if no suction of the bubbles by DT and their accumulation at the corneal end,
the test will be considered negative. Simultaneously, careful visualization of any change in
the shape of the ostium and intramural part of FT particularly during suction of the air
bubbles will be recorded in all cases. Tubal peristalsis is defined as observed osteal and
intramural tubal rhythmic opening and closing on maintained intrauterine pressure, i.e.,
periodic changes of DT in the form of widening followed by collapse on meticulous
observation. If the ostium and intramural part of the tube is obviously opened followed by
collapse and non-visualization of the pinhole dark spot of DT for a while, positive
peristalsis will be reported. The same steps will be repeated on the contralateral side and
reported.
