Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT05125692
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.
Study:
NCT05125692
Study Brief:
Protocol Section:
NCT05125692