Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04661098 |
| Other study ID # |
Darwish hymenotomy technique |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2013 |
| Est. completion date |
October 2019 |
Study information
| Verified date |
December 2020 |
| Source |
Woman's Health University Hospital, Egypt |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to test the use of a 10 mm laparoscopy trocar tip for formation of a new
vaginal orifice with preservation of an annular hymen (Darwish hymenotomy technique) in cases
of post pubertal imperforate hymen (IH). A prospective interventional case series done at a
minimally invasive surgery unit of a tertiary university hospital between July 2013 and
October 2019 comprising patients with primary amenorrhea and hematocolpus. Circular
hymenotomy using a 10 mm laparoscopy trocar tip and sleeve done under general anesthesia was
done in 36 cases. Documented vaginal patency with formation of an annular hymen in all cases
was reported on follow-up visits without reported intraoperative complications. Patient and
family satisfaction with excellent sensation of preserved hymen was also documented. Using a
10 mm laparoscopy trocar tip for formation of a new vaginal opening with preservation of
annular hymen (Darwish technique) in cases of postpubertal IH is a simple, effective and safe
procedure suitable for Islamic and conservative societies with excellent impact on the
psychological and emotional status of the patient and her family.
Description:
This study is a prospective interventional case series conducted at the Minimally Invasive
Surgery Unit of the Woman's Health University Hospital, Assiut, Egypt, between July 2013 and
October 2019. It was approved in May 2013 by the local ethical committee of the faculty of
Medicine, Assiut University. After detailed explanation of the study, all cases or parents
signed an informed consent to participate in this study. It comprised 43 cases with primary
amenorrhea and hematocolpus. Patients' complaints included a gradually progressive central
abdominal mass, pelvic pain getting worse over time disturbing her studies, urinary
retention, dysuria, constipation and dyschezia separately or collectively depending on the
chronicity of retained menstruation. Clinical examination started by downward labial traction
to separate the labia majora and minora sufficiently to visualize the distal introitus. Girls
with only IH as diagnosed after puberty (postpubertal) without any suspicion of associated
congenital anomaly were included in this study. Low transverse vaginal septum was diagnosed
in 4 cases that were excluded from this study. Differentiation between IH and transverse
vaginal septum relied mainly on clinical examination in the lithotomy position with insertion
of a uterine sound into the dimple. If the sound fails to go up, it is a case of IH. If it
goes up this means a low transverse vaginal septum that requires an advancement operation
with fixation of the edges of the septum to the introitus. In such cases, hymentomy will fail
with reformation of the septum as it is thick in contrast to the thin hymen. During
examination, distal vaginal atresia was excluded by the absence of hymnal distension on
Valsalva and absence of its bluish discoloration in addition to far existence of the
hematocolpos away from the vulva. It was reported in two cases that were also excluded from
the study. If the abdominal mass was noticed to be deviated to one side, a possibility of
type I obstructed hemi-vagina and ipsilateral renal agenesis (OHVIRA) raised and a
confirmatory MRI was requested. Only one case with OHVIRA type I (Blind hemi-vaginal septum
without an opening) was detected and excluded from the study. This case presented with
primary amenorrhea due to a rudimentary contralateral horn. Clinical examination of 36 cases
with IH was relatively easy as the patient presented with a vaginal bulge of thin hymenal
tissue with a dark or bluish hue caused by the hematocolpos behind it. If the physical
examination revealed a bulging hymen and ultrasonography confirmed the diagnosis of
hematocolpos, further imaging was not required. In selected cases with ambiguous diagnosis,
MRI was requested to assess the vaginal and the perineum in a meticulous way. For surgical
safety, prepubertal girls with IH were excluded.
The procedure stars by putting the patient in the lithotomy position in the OR. After
induction of general anesthesia, sterilization and toweling of the perineum was done.
Insertion of an indwelling urethral catheter and PR to exclude other anomalies or
abnormalities were done. The tip of a 10 mm laparoscopy trocar with a sharp triangular point
(Karl Storz, Tuttlingen, Germany) was inserted in the center of the most bulging point of the
IH. Once the edge of the sleeve followed the tip of the trocar tip into the hymen, no further
advancement of the trocar tip was made to avoid unintentional injuries by the trocar itself.
After its withdrawal, the sleeve was left insitu for drainage of the retained blood.
Suprapubic pressure was not done to avoid ascending infection by the negative pressure. After
complete stoppage of flow of the retained menstruation the sleeve was removed. Usually no
further intervention was needed. If oozing points were seen, a gentle bipolar coagulation was
used. The remaining hymenal ring was evaluated and documented in the patient's file whether
intact circular or not. All technical steps are shown in figure 1. After recovery, the
patient was kept for few hours in the postoperative ward then discharged. She was advised to
come for follow-up after the coming menstruation or after 40 days if no menses occur. She was
examined to ensure patency of the vagina, the integrity of the hymen and sonographically to
ensure absence of retained menstruation and to assess both kidneys. Subsequent follow-up
visits were optional whenever they notice any change in the menstrual flow. Otherwise
telephone calls were kept with them thereafter. Outcomes included hymenal ring integrity on
naked eye examination, patient satisfaction, relief of symptoms, and a feeling of well-being.
Due to rarity of cases, the same patient was used to compare preoperative and postoperative
results.
