Combined Hystroscopic and Laparoscopic Repair of CS Scar... | NCT07183501

Studies
Combined Hystroscopic and Laparoscopic Repair of CS Scar Disorder

NCT07183501

Sponsor

Assiut University

Status

Recruiting

Last Update Posted

Sep 19, 2025Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Cesarean Section Complications
Abnormal Uterine Bleeding

Interventions

Combined hystroscopic and laparoscopic repair

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 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Mar 1, 2027Estimated

First Submitted Date

Sep 5, 2025

First Submission Date that Met QC Criteria

Sep 17, 2025

First Posted Date

Sep 19, 2025Actual

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 17, 2025

Last Update Posted Date

Sep 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Combined hystroscopic and laparoscopic repair of symptomatic uterine Niche as new technique to maximize resolution of symptoms after niche repair with concomitant increase in RMT

Detailed Description

Not provided

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with symptomatic uterine niche	Experimental		Procedure: Combined hystroscopic and laparoscopic repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Combined hystroscopic and laparoscopic repair	Procedure	Hystroscopic isthmoplasty will be done first to ensure removal of chronically inflamed Unhealthy edges of niche, then laparoscopic exison of scar will be dine, followed by repair of the defect

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in Residual Myometrial Thickness	in mm	3 months

Secondary Outcomes

Measure	Description	Time Frame
Number of patients complete resolution of symptoms	dissappearance of symptoms	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

symptomatic uterine Niche :postmenstrual spotting

Exclusion Criteria:

contraindications for endoscopy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 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
Abdulrahman Rageh, Lecturer	Contact	+201005056259		Abdulrahmanrageh@med.aun.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university, women health hospital	Recruiting	Asyut	Asyut Governorate	71511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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