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Clinical Trials/NCT05062551
NCT05062551UnknownNot Applicable

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

Mervit Sersy1 site in 1 country50 target enrollmentStarted: July 16, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
size of the the niche post operatively

Study Overview

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.

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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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • previous cesarean sections
  • complain post menstrual spotting

Exclusion Criteria

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

Arms & Interventions

intervetion group

Experimental

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.

Intervention: three steps hysteroscopic resection of an isthmocele (Procedure)

Outcomes

Primary Outcomes

size of the the niche post operatively

Time Frame: 2 months

effectiveness of three steps method resection using hysteroscopy of an isthmocele

Secondary Outcomes

  • improving of post menstrual bleeding(2months)

Investigators

Sponsor
Mervit Sersy
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mervit Sersy

Assistant professor

Alexandria University

Study Sites (1)

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