Vaginal Repair of Post Cesarean Istmocele

Not Applicable

• Conditions: Gynecologic Disease
• Interventions: Procedure: vaginal surgical repair of isthmocele

• Registration Number: NCT05125692
• Lead Sponsor: Mansoura University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-04
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-11-06
• Last Update Submitted: 2021-11-06
• Study First Posted: 2021-11-18
• Last Update Posted: 2021-11-18
• Primary Completion: 2022-08-20
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• women diagnosed with symptomatic post cesarean isthmocele.
• should present with abnormal uterine bleeding .

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
women with symptomatic post cesarean Istmocele	vaginal surgical repair of isthmocele	vaginal surgical repair of post cesarean symptomatic isthmocele using conventional low cost surgical techniques

Primary Outcome Measures

Name	Time	Method
myometrial thickness in supracervical area	at 1 month postoperative	the myometrial thickness in the supracervical region is measured by transvaginal ultrasound postoperatively

Trial Locations

Locations (1)

Mansoura University Hospitals; 🇪🇬 Mansoura, Dakahlya Governorate, Egypt