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

NCT05062551 | Unknown DMC

• 1 other identifier: 0305227
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. .

Conditions

Abnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

• size of the the niche post operatively

  effectiveness of three steps method resection using hysteroscopy of an isthmocele

  2 months

Secondary Outcomes (1)

• improving of post menstrual bleeding

  2months

Study Arms (1)

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.

Procedure: three steps hysteroscopic resection of an isthmocele

Interventions

three steps hysteroscopic resection of an isthmocele PROCEDURE

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.

intervetion group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female
• previous cesarean sections
• complain post menstrual spotting

You may not qualify if:

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

Sponsors & Collaborators

• Mervit Sersy: lead

Study Sites (1)

Shatby Maternity University Hospital

Alexandria, El-Khartoum Square, 21131, Egypt

RECRUITING

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mervat MD Elsersy, MD

  Assistant professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mervat AM Elsersy, MD

CONTACT

+201096311548; msersy@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: July 16, 2021
• Primary Completion: October 15, 2021
• Study Completion: December 15, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

EG (1)