NCT07183501

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Jun 2024Mar 2027

Study Start

First participant enrolled

June 1, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

September 5, 2025

Last Update Submit

September 17, 2025

Conditions

Cesarean Section ComplicationsAbnormal Uterine Bleeding

Keywords

Cesarean SectionnicheCSD

Outcome Measures

Primary Outcomes (1)

  • change in Residual Myometrial Thickness

    in mm

    3 months

Secondary Outcomes (1)

  • Number of patients complete resolution of symptoms

    3 months

Study Arms (1)

Patients with symptomatic uterine niche

EXPERIMENTAL
Procedure: Combined hystroscopic and laparoscopic repair

Interventions

Combined hystroscopic and laparoscopic repairPROCEDURE

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

Patients with symptomatic uterine niche

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • symptomatic uterine Niche :postmenstrual spotting

You may not qualify if:

  • contraindications for endoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university, women health hospital

Asyut, Asyut Governorate, 71511, Egypt

RECRUITING

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Abdulrahman Rageh, Lecturer

CONTACT

+201005056259Abdulrahmanrageh@med.aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 19, 2025

Study Start

June 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

EG(1)