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

Abnormal Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05062551
• Other study ID #: 0305227
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: September 2021
• Source: Alexandria University
• Contact: Mervat AM Elsersy, MD
• Phone: +201096311548
• Email: msersy[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Metrorrhagia
• Uterine Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
Egypt	Shatby Maternity University Hospital	Alexandria	El-Khartoum Square

Sponsors (1)

Lead Sponsor	Collaborator
Mervit Sersy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	size of the the niche post operatively	effectiveness of three steps method resection using hysteroscopy of an isthmocele	2 months
Secondary	improving of post menstrual bleeding	no more post menstrual spotting	2months