Vaginal Repair of Post Cesarean Istmocele | NCT05125692

Studies
Vaginal Repair of Post Cesarean Istmocele

NCT05125692

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Nov 18, 2021Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Gynecologic Disease

Interventions

vaginal surgical repair of 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

Sep 4, 2021Actual

Primary Completion Date

Aug 20, 2022Estimated

Completion Date

Dec 20, 2022Estimated

First Submitted Date

Sep 15, 2021

First Submission Date that Met QC Criteria

Nov 6, 2021

First Posted Date

Nov 18, 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

Nov 6, 2021

Last Update Posted Date

Nov 18, 2021Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

20 WOMEN WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE (NICHE) WILL BE RECRUITED EVALUATED AND SUBJECTED TO A VAGINAL REPAIR OF THE DEFECT, RESULTS WILL BE ANALYZED.

Detailed Description

METHODS:

Subjects: women in childbearing period with abnormal uterine bleeding or infertility attributed to post cesarean isthmocele (sample size to be calculated)
Preoperative evaluation: transvaginal ultrasound to exclude any other uterine or adnexal pathology, and to measure:
1. Distance from the external cervical os to the lower end of the isthmocele (A)
2. Distance from the external cervical os to the upper end of the isthmocele(B)
3. Length of the isthmocele (B-A)
4. Residual myometrial thickness (the least) of the isthmocele.
Routine preoperative workup.
The technique:
- Postmenstrual
- Spinal anesthesia
- Sterilization of the perineum and vagina
- Cervical dilation up to 8mm using Hegar's dilators
- Marking the previously measured points A & B
- Making 2 transverse incisions, one 5mm below A and the other 5 mm above B.
- The rectangular area between the 2 incisions is excised while the Hegar's dilator number 8 in in situ.
- Hemostasis is performed using diathermy.
- The upper and lower edges of the incision are approximated using number 2/0 vicryl on cutting needle taking 3 to 4 interrupted sutures
The patients with uneventful postoperative course are discharged from hospital after 8 hours with doxycycline 100 mg bid for 5 days.
Sexual intercourse is avoided for 4 weeks postoperative
postoperative transvaginal ultrasound follow up; at 1 month postoperative.
Data will be statistically analyzed and results will be tabulated.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
women with symptomatic post cesarean Istmocele	Other	vaginal surgical repair of post cesarean symptomatic isthmocele using conventional low cost surgical techniques	Procedure: vaginal surgical repair of isthmocele

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vaginal surgical repair of isthmocele	Procedure	after preoperative identification of the borders of the isthmocele using transvaginal ultrasound measurements, the isthmocele is repaired via vaginal approach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
myometrial thickness in supracervical area	the myometrial thickness in the supracervical region is measured by transvaginal ultrasound postoperatively	at 1 month postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women diagnosed with symptomatic post cesarean isthmocele.
should present with abnormal uterine bleeding .

Exclusion Criteria:

presence of any other uterine pathology,
presence of adnexal pathology,
presence of malignancies,
presence of pregnancy,
presence of infection in the lower genital tract ,
general cause of bleeding
women not accepting the procedure,
women not consented

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
osama M Warda, MD	Contact	01066153212	+20	osamawarda@mans.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University Hospitals	Recruiting	Al Mansurah	Dakahlya Governorate	35516	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D005831	Genital Diseases, Female

Ancestor Terms

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

Browse Leaves

Not provided

Browse Branches

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