Vaginal Repair of Post Cesarean Istmocele

Gynecologic Disease Clinical Trial

— OWarda  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05125692
• Other study ID #: osama Istmocele
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Gynecologic Disease

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