Vaginal Repair of Post Cesarean Istmocele (OWarda)

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

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

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Disease
• Intervention / Treatment: Procedure: vaginal surgical repair of isthmocele

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: osama m warda, MD; Phone Number: +20 01066153212; Email: osamawarda@mans.edu.eg

Study Locations

• Egypt
  • Dakahlya Governorate
    • Mansoura, Dakahlya Governorate, Egypt, 35516
      • Recruiting
      • Mansoura University Hospitals
      • Contact: osama m warda, MD; Phone Number: +20 01066153212; Email: osamawarda@mans.edu.eg
      • Principal Investigator: osama m warda, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: women with symptomatic post cesarean Istmocele; vaginal surgical repair of post cesarean symptomatic isthmocele using conventional low cost surgical techniques	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
myometrial thickness in supracervical area	the myometrial thickness in the supracervical region is measured by transvaginal ultrasound postoperatively	at 1 month postoperative

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2021
• Primary Completion (Anticipated): August 20, 2022
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: November 6, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: osama Istmocele

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No