Development of Isthmocele Symptom Severity and Quality of Life Scale

NCT06562231 | Recruiting DMC

• 1 other identifier: isthmocele and quality of life
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

Isthmocele, also known as cesarean scar defect (CSD), is the disruption of the integrity of the myometrium in the cesarean section incision and the indentation of the opening in the myometrium towards the visceral peritoneum. Residual menstrual blood accumulating in the isthmocele sac can cause chronic endometritis, anormal uterine bleeding, infertility and chronic pelvic pain. There is currently no quality of life scale that assesses isthmocele symptoms. A scale is needed to determine the positive effect on the patient's quality of life after the surgeries are performed. This study it is aimed to develop a scale that evaluates the severity of isthmocele symptoms and the impact on quality of life due to isthmocele.

Conditions

Quality of Life

Keywords

isthmocele; quality of life; questionnaire; abnormal uterine bleeding

Outcome Measures

Primary Outcomes (1)

• Development of isthmocele symptom severity and quality of life scale

  In the literature review, there is currently no quality of life scale for isthmocele symptoms. There is a need for a scale to detect changes in patients' quality of life after surgery due to isthmocele.This study aimed to create a questionnaire that can be administered immediately before surgery and six weeks after surgery to assess the severity of isthmocele symptoms and the impact of isthmocele on quality of life.

  3 year

Study Arms (1)

questionnaire group

The patient will fill out the questionnaire form with the diagnosis of isthmocele.

Other: quality of life scale

Interventions

quality of life scale OTHER

This study will be conducted on women diagnosed with symptomatic isthmocele after cesarean section. Researchers will prepare scale questions, and the survey questions will be developed after obtaining an expert opinion from 20 experts to be evaluated by psychiatry, obstetrics, and public health experts. The patient will fill out the questionnaire form with the diagnosis of isthmocele. Oral and written consent will be obtained from the patients.

questionnaire group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study will be conducted on women diagnosed with symptomatic isthmocele after cesarean section.

You may qualify if:

• Patients with isthmocele symptoms three months after cesarean delivery will be included in the study.

You may not qualify if:

• The study will not include findings that may be confused with isthmocele symptoms, such as uterine fibroids and endometrial polyps.
• Patients with acute vaginitis and pelvic inflammatory disease will not be included in the study.

Sponsors & Collaborators

• Hilal Yuvacı: lead

Study Sites (1)

Sakarya University School of Medicine

Sakarya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hilal Uslu Yuvacı

  Sakarya University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilal Uslu Yuvacı

CONTACT

+905056236937; hilaly@sakarya.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Obstetrics and Gynecology

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: August 20, 2024
• Study Start: January 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 30, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)