Clinical trial NCT05062551: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Abnormal Uterine Bleeding
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: size of the the niche post operatively
timeFrame: 2 months
Secondary outcomes:
measure: improving of post menstrual bleeding
timeFrame: 2months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Shatby Maternity University Hospital
state: El-Khartoum Square
Study officials:
affiliation: Assistant professor
name: Mervat MD Elsersy, MD
role: PRINCIPAL_INVESTIGATOR
References: