Immunohistopathologic Findings of Cesarean Scar Niche

NCT06466343 | Recruiting

• 1 other identifier: Soh-Med-24-05-06MD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 myometrium's 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.

Conditions

Cesarean Scar Niche

Keywords

cesarean scar, Niche

Outcome Measures

Primary Outcomes (1)

• the incidence and type of different pathological variations within examined CS niche specimens.

  measure the incidence and type of different pathological variations within examined CS niche specimens.

  three weeks

Secondary Outcomes (1)

• correlation of predominant pathological variation with symptoms of patient and radiological findings.

  2 weeks

Study Arms (1)

symptomatic non pregnant women

OTHER

Operative hysteroscopy will be used for surgical treatment in the cases. Hysteroscopic management of niche will be done according to the following steps: Operative procedure will be done postmenstrual, cervical preparation will be done by giving the patients misoprostol (misotac®) 400mcg two hours preoperative. Surgically, operative resectoscope (KARL STORZ, Germany,27 Fr gauge) will be inserted into the uterine cavity after cervical dilatation by Hegar uterine dilator up to 8. Distilled water will be used as distension media. Using a resectoscope, the lower edge of the niche will be trimmed, the base will be coagulated by using monopolar cutting current at 30-50 MHz.

Procedure: hysteroscopic resection of lower edge of cesarean scar niche

Interventions

hysteroscopic resection of lower edge of cesarean scar niche PROCEDURE

Operative hysteroscopy will be used for surgical treatment in the cases. Hysteroscopic management of niche will be done according to the following steps: Operative procedure will be done postmenstrual, cervical preparation will be done by giving the patients misoprostol (misotac®) 400mcg two hours preoperative. Surgically, operative resectoscope (KARL STORZ, Germany,27 Fr gauge) will be inserted into the uterine cavity after cervical dilatation by Hegar uterine dilator up to 8. Distilled water will be used as distension media. Using a resectoscope, the lower edge of the niche will be trimmed, the base will be coagulated by using monopolar cutting current at 30-50 MHz. The resected parts will be submitted together as one sampled specimen in one container of formaldehyde 30% (dissolved 800 ml water and 200 ml formaldehyde)

symptomatic non pregnant women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Any Women with history of previous CS once or more with period more than one year from the last CS and had CS scar defect diagnosed by TVUS.

You may not qualify if:

• All women diagnosed with pelvic inflammatory disease, suspected with gynecological malignancy, postmenopausal women, women with heart disease, liver disease, renal impairment or bleeding tendency will be excluded from the study.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospitals

Sohag, Egypt

RECRUITING

Study Officials

• mohamed Ab Galal, A.lecturer

  sohag faculty of medicine sohag university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed Ab Galal, A.Lecturer

CONTACT

01095926603; mohamed_hussien1@med.sohag.edu.eg

Amr O Abelkareem, A.lecturer

CONTACT

01001259562; amr.oth@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 20, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)