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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05125692
Other study ID # osama Istmocele
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 4, 2021
Est. completion date December 20, 2022

Study information

Verified date September 2021
Source Mansoura University
Contact osama M Warda, MD
Phone 01066153212
Email osamawarda@mans.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

20 WOMEN WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE (NICHE) WILL BE RECRUITED EVALUATED AND SUBJECTED TO A VAGINAL REPAIR OF THE DEFECT, RESULTS WILL BE ANALYZED.


Description:

METHODS: - 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 20, 2022
Est. primary completion date August 20, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - women diagnosed with symptomatic post cesarean isthmocele. - should present with abnormal uterine bleeding . Exclusion Criteria: - presence of any other uterine pathology, - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Egypt Mansoura University Hospitals Mansoura Dakahlya Governorate

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary myometrial thickness in supracervical area the myometrial thickness in the supracervical region is measured by transvaginal ultrasound postoperatively at 1 month postoperative
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