Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-01-03 @ 9:15 PM
Study NCT ID:
NCT05125692
Status:
UNKNOWN
Last Update Posted:
2021-11-18
First Post:
2021-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Repair of Post Cesarean Istmocele
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Vaginal Repair of Symptomatic Postcesarean Isthmocele: Evaluating A Simple Novel Technique
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OWarda
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.
* 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: