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

• Sponsor: Mervit Sersy (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05062551
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 10

Study Details

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.

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Condition or Disease	Intervention/Treatment	Phase
Abnormal Uterine Bleeding	Procedure: three steps hysteroscopic resection of an isthmocele	N/A

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
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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.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)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Three Steps Hysteroscopic Repair of Post Caesarean Isthmocele in Patients With Post Menstrual Spotting
• Actual Study Start Date: Jul 16, 2021
• Anticipated Primary Completion Date: Oct 15, 2021
• Anticipated Study Completion Date: Dec 15, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: intervetion group 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; 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.

Outcome Measures

Primary Outcome Measures

1. size of the the niche post operatively [2 months]

   effectiveness of three steps method resection using hysteroscopy of an isthmocele

Secondary Outcome Measures

1. improving of post menstrual bleeding [2months]

   no more post menstrual spotting

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shatby Maternity University Hospital	Alexandria	El-Khartoum Square	Egypt	21131

Sponsors and Collaborators

• Mervit Sersy

Investigators

• Principal Investigator: Mervat MD Elsersy, MD, Assistant professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mervit Sersy, Assistant professor, Alexandria University
• ClinicalTrials.gov Identifier: NCT05062551
• Other Study ID Numbers: 0305227
• First Posted: Sep 30, 2021
• Last Update Posted: Sep 30, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Uterine Hemorrhage; Metrorrhagia

Study Results

No Results Posted as of Sep 30, 2021