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

Primary Purpose

Abnormal Uterine Bleeding

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

three steps hysteroscopic resection of an isthmocele

About this trial

This is an interventional treatment trial for Abnormal Uterine Bleeding

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Shatby Maternity University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervetion group

Arm Description

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.

Outcomes

Primary Outcome Measures

size of the the niche post operatively

effectiveness of three steps method resection using hysteroscopy of an isthmocele

Secondary Outcome Measures

improving of post menstrual bleeding

no more post menstrual spotting

Full Information

NCT ID

NCT05062551

First Posted

September 21, 2021

Last Updated

September 21, 2021

Sponsor

Mervit Sersy

1. Study Identification

Unique Protocol Identification Number

NCT05062551

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 16, 2021 (Actual)

Primary Completion Date

October 15, 2021 (Anticipated)

Study Completion Date

December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mervit Sersy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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. .

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abnormal Uterine Bleeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

the 50 patients 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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intervetion group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

three steps hysteroscopic resection of an isthmocele

Intervention Description

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.

Primary Outcome Measure Information:

Title

size of the the niche post operatively

Description

effectiveness of three steps method resection using hysteroscopy of an isthmocele

Time Frame

2 months

Secondary Outcome Measure Information:

Title

improving of post menstrual bleeding

Description

no more post menstrual spotting

Time Frame

2months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mervat AM Elsersy, MD

Phone

+201096311548

msersy@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mervat MD Elsersy, MD

Organizational Affiliation

Assistant professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shatby Maternity University Hospital

City

Alexandria

State/Province

El-Khartoum Square

ZIP/Postal Code

21131

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mervat AM Elsersy, MD

Phone

+201096311548

msersy@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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