Effectiveness of Three Steps Hysteroscopic Repair of Post... | NCT05062551

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

NCT05062551

Sponsor

Mervit Sersy

Status

Unknown status

Last Update Posted

Sep 30, 2021Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Abnormal Uterine Bleeding

Interventions

three steps hysteroscopic resection of an isthmocele

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2021Actual

Primary Completion Date

Oct 15, 2021Estimated

Completion Date

Dec 15, 2021Estimated

First Submitted Date

Sep 21, 2021

First Submission Date that Met QC Criteria

Sep 21, 2021

First Posted Date

Sep 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2021

Last Update Posted Date

Sep 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
size of the the niche post operatively	effectiveness of three steps method resection using hysteroscopy of an isthmocele	2 months

Secondary Outcomes

Measure	Description	Time Frame
improving of post menstrual bleeding	no more post menstrual spotting	2months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mervat AM Elsersy, MD	Contact	+201096311548		msersy@hotmail.com

Overall Officials

Name	Affiliation	Role
Mervat MD Elsersy, MD	Assistant professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shatby Maternity University Hospital	Recruiting	Alexandria	El-Khartoum Square	21131	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D008796	Metrorrhagia

Ancestor Terms

ID	Term
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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.