Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04357054 |
| Other study ID # |
Darwish test in myoma |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 5, 2023 |
| Est. completion date |
May 25, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Woman's Health University Hospital, Egypt |
| Contact |
Atef Darwish |
| Phone |
0201001572723 |
| Email |
atef_darwish[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to test the impact of different types of liomyoma on Darwish test
(hysteroscopic bubble suction test and tubal peristalsis of Darwish triad ) in women
subjected to postmenstrual combined laparoscopy and hysteroscopy.
Description:
It will include infertile women planned for combined laparoscopy and hysteroscopy as an
integral part of infertility wok-up. 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, 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. All cases should have basic TVS examination, normal husband's semen analysis, and
a recent HSG. Basic TVs should comment on any uterine pathology . If a uterine myoma is seen
with its characteristic hypoechoic, but can be isoechoic, or even hyperechoic shadow compared
to normal myometrium. Calcification is seen as echogenic foci with posterior shadowing.
Cystic areas of necrosis or degeneration may be seen. Definition of the number, site and
proximity to corneal ends of the uterus should be addressed.
Sample size calculation based on our previous study on the prevalence of tubal patency using
bubble suction test in infertility patients with normal FT (5). 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
liomyomata, 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).
Eligible women will subjected to combined laparoscopy and hysteroscopy essentially
postmenstrual. Since this study will include infertility patients consenting for all options
of endoscopic management of any infertility problem, a decision of general anesthesia will be
made in all cases. The abdomen, vulva, vagina and the thighs will be disinfected with a 10%
povidone-iodine solution. Sterile draping will be applied. The procedure started by a
standard double puncture laparoscopy to search for any possible cause of infertility. An
additional auxiliary portal will be made whenever a therapeutic procedure is needed. After
completion of laparoscopic procedures to enhance fertility like myomectomy, adhesiolysis or
management of endometriosis, tubal perchromation test using methylene blue dye will be done
with comment on tubal patency in both sides. FT length, integrity, size, external surface and
fimbriae will be reported bilaterally.
Thereafter, conventional diagnostic hysteroscopy will be performed using a 4mm 30° rigid
scope with a 5mm outer sheath (Karl Storz, Tutlingen, Germany), and 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
as previously described (5). 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, myoma, and growth.
If the uterus appears externally and internally normal , the patient allocated as group A. If
there is one or more liomyomata the patient allocated as group B.
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 polypi
or fine adhesions (figure 3, video 2) 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 (figure 4). 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 repeated on the contralateral side and reported.
