Vaginal Repair of Post Cesarean Istmocele (OWarda)

Mansoura University

Status: Unknown

Conditions: Gynecologic Disease

Treatments: Procedure: vaginal surgical repair of isthmocele

Study type: Interventional

Funder types: Other

Identifiers

NCT05125692

osama Istmocele

Details and patient eligibility

About

20 WOMEN WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE (NICHE) WILL BE RECRUITED EVALUATED AND SUBJECTED TO A VAGINAL REPAIR OF THE DEFECT, RESULTS WILL BE ANALYZED.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

women with symptomatic post cesarean Istmocele

Other group

Description:

vaginal surgical repair of post cesarean symptomatic isthmocele using conventional low cost surgical techniques

Treatment:

Procedure: vaginal surgical repair of isthmocele