CClinicalTrials.gg
Status unknownNCT05062551Updated Sep 30, 2021

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

An interventional study of three steps hysteroscopic resection of an isthmocele in Abnormal Uterine Bleeding, sponsored by Mervit Sersy. Status unknown at 1 site in Egypt. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-09-30.

Sponsored by Mervit Sersy · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
25 Years to 45 Years
Sex
Female
01

Study 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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Read the 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.

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Conditions studied

  • Abnormal Uterine Bleeding
03

In context

Uterine Hemorrhage

156 studies on the registry are indexed under Uterine Hemorrhage; 19 are open to participants now.

This study's planned enrollment of 50 is below the median of 96 across 111 interventional studies indexed under Uterine Hemorrhage.

Browse Uterine Hemorrhage studies →

Lead sponsor

This is the only study on the registry with Mervit Sersy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • female
  • previous cesarean sections
  • complain post menstrual spotting

Exclusion criteria

Exclusion Criteria:

  • other genital tract abnormality
  • other uterine causes pf bleeding residual myometrial thickness less than 3mm
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • Procedurethree 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.

06

What researchers measure

Primary outcomes

  1. size of the the niche post operatively

    effectiveness of three steps method resection using hysteroscopy of an isthmocele

    Time frame: 2 months

Secondary outcomes

  1. improving of post menstrual bleeding

    no more post menstrual spotting

    Time frame: 2months

07

Study locations

1 of 1 sites recruiting
  • Shatby Maternity University Hospital
    Alexandria, El-Khartoum Square 21131, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05062551
Lead sponsor
Mervit Sersy
Responsible party
Mervit Sersy (Assistant professor, Alexandria University) — Sponsor-investigator
First posted
Sep 30, 2021
Start date
Jul 16, 2021
Primary completion
Oct 15, 2021 (estimated)
Completion
Dec 15, 2021 (estimated)
Last update
Sep 30, 2021

Study contacts

Mervat AM Elsersy, MD
Contact
msersy@hotmail.com
+201096311548
Mervat MD Elsersy, MD
principal investigator · Assistant professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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