Effectiveness of Three Steps Hysteroscopic Repair of Post Caesarean Isthmocele in Patients With Post Menstrual Spotting

September 21, 2021 updated by: Mervit Sersy

Isthmocele is one complications of repeat cesarean sections which is considered as a pocket .that accumulate menstrual blood causing post- menstrual spotting Hysteroscopic resection of the edges of the isthmocele is considered the best treatment option available up to date. Aim of the work: Asses the effectiveness of three steps method resection using hysteroscopy of an isthmocele in patients complained of post -menstrual bleeding with confirmed presence of isthmocele.

.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The incidence rate of cesarean deliveries has been dramatically increased in Egypt.(1) Isthmocele is one of the known complications of repeat cesarean sections.(2) Post- menstrual spotting and many other gynecological complains have been correlated to this isthmocele which is considered as a pocket that accumulate menstrual blood. (3) Hysteroscopic resection of the edges of the isthmocele is considered the best treatment option available up to date.(4) Aim of the work: Asses the effectiveness of three steps method resection using hysteroscopy of an isthmocele in patients complained of post-menstrual bleeding with confirmed presence of isthmocele.

Patients: 50 patients complained of post-menstrual bleeding with confirmed presence of isthmocele. After written consent, the patient will be subjected to three steps hysteroscopic resection of an isthmocele by removing the distal edge of the niche then the proximal edge and lastly ball cauterization of the floor of the pouch of the isthmocele. Post-operative trans-vaginal ultrasound and follow up for 2 menstrual cycles.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El-Khartoum Square
      • Alexandria, El-Khartoum Square, Egypt, 21131
        • Recruiting
        • Shatby maternity university hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female
  • previous cesarean sections
  • complain post menstrual spotting

Exclusion Criteria:

  • other genital tract abnormality
  • other uterine causes pf bleeding residual myometrial thickness less than 3mm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervetion group
50 patients complained of post-menstrual bleeding with confirmed presence of isthmocele. After written consent, the patient will be subjected to three steps hysteroscopic resection of an isthmocele by removing the distal edge of the niche then the proximal edge and lastly ball cauterization of the floor of the pouch of the isthmocele. Post-operative trans vaginal ultrasound and follow up for 2 menstrual cycles.
Procedure: three steps hysteroscopic resection of an isthmocele
removing the distal edge of the niche then the proximal edge and lastly ball cauterization of the floor of the pouch of the isthmocele. Post-operative trans vaginal ultrasound and follow up for 2 menstrual cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
size of the the niche post operatively
Time Frame: 2 months
effectiveness of three steps method resection using hysteroscopy of an isthmocele
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improving of post menstrual bleeding
Time Frame: 2months
no more post menstrual spotting
2months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mervit Sersy

Investigators

  • Principal Investigator: Mervat MD Elsersy, MD, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2021

Primary Completion (Anticipated)

October 15, 2021

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0305227

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe