Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466343
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-10
Brief Title:
Immunohistopathologic Findings of Cesarean Scar Niche
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Immunohistopathologic Findings of Cesarean Scar Niche
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Niche is iatrogenic pouch like defect present on the uterine isthmus anterior wall where a previous caesarean section scar was made Still a niche has generally been defined as the myometriums depression of at least 2 mm Lumbanraja et al 2024
The literature is lacking in information about the accurate histopathologic characteristics of cesarean scar niche ridges that have been removed by hysteroscopy as well as what critical findings to highlight and what gynaecologists can anticipate from pathology reports of cesarean scar niche specimens AbdullGaffar Almulla 2022
In this study the aim of the work is to study the histopathologic findings in cesarean scar niche specimens repaired by hysteroscopy in our institution identify the causes of local thinning of the uterine scar after c-section to direct gynecologists regarding the efficacy of their hysteroscopic corrective repair of cesarean scar niche concerning the amelioration of symptoms restoration of fertility and patient follow-up
The literature is lacking in information about the accurate histopathologic characteristics of cesarean scar niche ridges that have been removed by hysteroscopy as well as what critical findings to highlight and what gynaecologists can anticipate from pathology reports of cesarean scar niche specimens AbdullGaffar Almulla 2022
In this study the aim of the work is to study the histopathologic findings in cesarean scar niche specimens repaired by hysteroscopy in our institution identify the causes of local thinning of the uterine scar after c-section to direct gynecologists regarding the efficacy of their hysteroscopic corrective repair of cesarean scar niche concerning the amelioration of symptoms restoration of fertility and patient follow-up
Detailed Description:
Subjects Methods Study will be conducted on non-pregnant women with symptomatic uterine scar niche after lower segment CS at Obstetrics and Gynecology department at Sohag University Hospitals
Patient recruitment
All eligible patients attending at the Obstetrics and Gynecology outpatient clinic at the department will be approached by the attending physician A through explanation about the nature of the study to each patient All patients agreeing to participate in the study will be asked to sign the informed written consent before enrollment in the study
Ultrasound examination
Uterine scar niche will be diagnosed by transvaginal Logic P7 GE US frequency 5060Hz postmenstrual In longitudinal plane of the uterus at anterior wall at site of CS the depth width and residual myometrial thickness will be measured All measures will be done by single operator
Niche is iatrogenic pouch like defect present on the uterine isthmus anterior wall where a previous caesarean section scar was madeThe myometriums depression of at least 2 mm
Operative procedure
For every patient related clinical data will be gathered age parity clinical presentation number of previous CSs history of secondary infertility history of previous niche repair surgeries and follow-up data will be included in this
Operative hysteroscopy will be used for surgical treatment in the cases
Histopathological examination
The hematoxylin and eosin HE slides will be inspected to identify any changes related to the mucosa as well as the types of lining mucosa of the resected edges the types of stroma and stroma-associated changes the presence of myometrial tissue and scarring Slides will be also screened for inflammatory hemorrhagic degenerative changes foreign body giant cell reaction and Masson trichrome stain for staining of fibrosis Higuchi et al 2022
Immunohistochemistry
Using a sliding microtome all paraffin-embedded blocks will be cut into 4-µm-thick sections The parts will be floated in a water bath at 42C before being put on slides The antigens will be recovered in an antigen retrieval reagent following deparaffinization CD3 a marker for T lymphocyte CD20 a marker for B lymphocytes and CD34 a marker for angiogenesis
Follow up
Patients will be asked to come after 3 months for asking about improvement of symptoms quality of life transvaginal US evaluation will be done and a questionnaire will be filled out Herdman et al2003
Statistical analysis
The collected data was organized tabulated and statistically analyzed using Statistical Package for Social Science SPSS version 16 SPSS Inc USA For quantitative data mean and standard deviation SD will be calculated and for comparison between two means the students t test will be used For qualitative data the frequency and percent distribution will be calculated and for comparison between groups chi square X2 will be used For interpretation of results p value will be significant if less than 005
Patient recruitment
All eligible patients attending at the Obstetrics and Gynecology outpatient clinic at the department will be approached by the attending physician A through explanation about the nature of the study to each patient All patients agreeing to participate in the study will be asked to sign the informed written consent before enrollment in the study
Ultrasound examination
Uterine scar niche will be diagnosed by transvaginal Logic P7 GE US frequency 5060Hz postmenstrual In longitudinal plane of the uterus at anterior wall at site of CS the depth width and residual myometrial thickness will be measured All measures will be done by single operator
Niche is iatrogenic pouch like defect present on the uterine isthmus anterior wall where a previous caesarean section scar was madeThe myometriums depression of at least 2 mm
Operative procedure
For every patient related clinical data will be gathered age parity clinical presentation number of previous CSs history of secondary infertility history of previous niche repair surgeries and follow-up data will be included in this
Operative hysteroscopy will be used for surgical treatment in the cases
Histopathological examination
The hematoxylin and eosin HE slides will be inspected to identify any changes related to the mucosa as well as the types of lining mucosa of the resected edges the types of stroma and stroma-associated changes the presence of myometrial tissue and scarring Slides will be also screened for inflammatory hemorrhagic degenerative changes foreign body giant cell reaction and Masson trichrome stain for staining of fibrosis Higuchi et al 2022
Immunohistochemistry
Using a sliding microtome all paraffin-embedded blocks will be cut into 4-µm-thick sections The parts will be floated in a water bath at 42C before being put on slides The antigens will be recovered in an antigen retrieval reagent following deparaffinization CD3 a marker for T lymphocyte CD20 a marker for B lymphocytes and CD34 a marker for angiogenesis
Follow up
Patients will be asked to come after 3 months for asking about improvement of symptoms quality of life transvaginal US evaluation will be done and a questionnaire will be filled out Herdman et al2003
Statistical analysis
The collected data was organized tabulated and statistically analyzed using Statistical Package for Social Science SPSS version 16 SPSS Inc USA For quantitative data mean and standard deviation SD will be calculated and for comparison between two means the students t test will be used For qualitative data the frequency and percent distribution will be calculated and for comparison between groups chi square X2 will be used For interpretation of results p value will be significant if less than 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None