Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-09-04
2022-12-20
Brief Summary
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Detailed Description
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* Subjects: women in childbearing period with abnormal uterine bleeding or infertility attributed to post cesarean isthmocele (sample size to be calculated)
* Preoperative evaluation: transvaginal ultrasound to exclude any other uterine or adnexal pathology, and to measure:
1. Distance from the external cervical os to the lower end of the isthmocele (A)
2. Distance from the external cervical os to the upper end of the isthmocele(B)
3. Length of the isthmocele (B-A)
4. Residual myometrial thickness (the least) of the isthmocele.
* Routine preoperative workup.
* The technique:
* Postmenstrual
* Spinal anesthesia
* Sterilization of the perineum and vagina
* Cervical dilation up to 8mm using Hegar's dilators
* Marking the previously measured points A \& B
* Making 2 transverse incisions, one 5mm below A and the other 5 mm above B.
* The rectangular area between the 2 incisions is excised while the Hegar's dilator number 8 in in situ.
* Hemostasis is performed using diathermy.
* The upper and lower edges of the incision are approximated using number 2/0 vicryl on cutting needle taking 3 to 4 interrupted sutures
* The patients with uneventful postoperative course are discharged from hospital after 8 hours with doxycycline 100 mg bid for 5 days.
* Sexual intercourse is avoided for 4 weeks postoperative
* postoperative transvaginal ultrasound follow up; at 1 month postoperative.
* Data will be statistically analyzed and results will be tabulated.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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women with symptomatic post cesarean Istmocele
vaginal surgical repair of post cesarean symptomatic isthmocele using conventional low cost surgical techniques
vaginal surgical repair of isthmocele
after preoperative identification of the borders of the isthmocele using transvaginal ultrasound measurements, the isthmocele is repaired via vaginal approach
Interventions
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vaginal surgical repair of isthmocele
after preoperative identification of the borders of the isthmocele using transvaginal ultrasound measurements, the isthmocele is repaired via vaginal approach
Eligibility Criteria
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Inclusion Criteria
* should present with abnormal uterine bleeding .
Exclusion Criteria
* presence of adnexal pathology,
* presence of malignancies,
* presence of pregnancy,
* presence of infection in the lower genital tract ,
* general cause of bleeding
* women not accepting the procedure,
* women not consented
20 Years
40 Years
FEMALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Locations
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Mansoura University Hospitals
Al Mansurah, Dakahlya Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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osama m warda, MD
Role: primary
Other Identifiers
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osama Istmocele
Identifier Type: -
Identifier Source: org_study_id