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Vaginal Repair of Post Cesarean Istmocele

Vaginal Repair of Symptomatic Postcesarean Isthmocele: Evaluating A Simple Novel Technique

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05125692
Acronym
OWarda
Enrollment
20
Registered
2021-11-18
Start date
2021-09-04
Completion date
2022-12-20
Last updated
2021-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Disease

Brief 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.

Detailed 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.

Interventions

PROCEDUREvaginal surgical repair of isthmocele

after preoperative identification of the borders of the isthmocele using transvaginal ultrasound measurements, the isthmocele is repaired via vaginal approach

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

WOMEN IN CHILDBEARING PERIOD WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
myometrial thickness in supracervical areaat 1 month postoperativethe myometrial thickness in the supracervical region is measured by transvaginal ultrasound postoperatively

Countries

Egypt

Contacts

Primary Contactosama M Warda, MD
osamawarda@mans.edu.eg01066153212

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026