The Identification of Optimal Ultrasonografic Tecniques for Determining the Location , Size and the Surgical Methods of Intestinal Endometriotric Nodules (Sonography)

The identification of optimal ultrasonografic tecniques for determining the location , size and the surgical methods of intestinal endometriotric nodules

Study Overview

• Status: Recruiting
• Conditions: Endometriosis, Rectum; ULTRASONOGRAPHY
• Intervention / Treatment: Diagnostic test: Ultrasonography

Detailed Description

Nulliparous patients who had diagnosed with endometriosis ( endometrioma and/or deep endometriosis) without additional gynecological patology applying for routine gynecological check-up to Zeynep Kamil Training and Research Hospital, Gnecology and Obstetrics Clinic between March 2020 and March 2021 will be included in the study.Inclusion criteria in the study. Inclusion criterias are the presence of endometrioma and/or endometriosis diagnosed with ultrasonographic evaluation, nulliparity,no additional gynecological patology such as myoma uteri, polype, a history of pelvic inflammatuar disease, a history of cervical or uterine surgery, uterine anomalies as well as patients in the control group will be nulliparous and have no gynecological patology including endometrioma and/or endometriosis.All patients will be evaluated in the follicular phase.With the ultrasonographic examination, the uterine version ( anteversion or retroversion) will be evaluated, the length of the uterus (from fundus to cervix on the saggital axis), the anterior-posterior widest uterin length ( at the level of corpus uteri), the cervical length (the distance between the internal os and external os), the cervical anteroposterior length ath the internal os level and the servical canal length at the internal os level, uterocervical angle (the angle between the longitudinal axis of the cervix and the longitudinal axis of the uterine body will be measured three times consecutively , the avarage of the three measurements will be recoreded).with the 90 degree rotation of the probe at the transverse axis the width of the widest corpus level of uterus and the width of the cervix will be measured.Measurements will be made by the same clinician with the same ultrasound device. These measurements and the patients' age, BMI(body mass index), menarche cycle duration, dysmenorrhea, dyspareunia, family history in terms of endometriosis, endometrisosis stage will be recorded.

• Study Type: Observational
• Enrollment (Anticipated): 16

Contacts and Locations

• Study Contact: Name: Resul Karakus, MD; Phone Number: 00905059164216; Email: resul-karakus@hotmail.com

Study Locations

• Turkey
  • Uskudar
    • Istanbul, Uskudar, Turkey, 34668
      • Recruiting
      • Zeynep Kamil Maternity and Childrens Training and Research Hospital
      • Contact: Resul Karakus, MD; Phone Number: 05059164216; Email: resul-karakus@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Non- virgin Female Patients having only intestinal findings of deep infiltrative endometriosis aged between 18-45 years old ,

Description

Inclusion Criteria:

• Diagnosed with deep infiltrative endometriosis and intestinal involvement
• Treatment will be done surgically
• Patients should be nonvirgin

Exclusion Criteria:

• Patient has one or more extra -intestinal findings of deep infiltrative endometiosis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients Diagnosed with Endometriosis (or endometrioma alone); Nulliparous patients who had diagnosed with endometriosis, no additional gynecological patology such as myoma uteri, polype, a history of pelvic inflammatuar disease, a history of cervical or uterine surgery, uterine anomalies	Diagnostic test: Ultrasonography; The identification of optimal ultrasonografic tecniques for determining the location , size and the surgical methods of intestinal endometriotric nodules.
Patients With No Gynecological Pathology; Nulliparous patients who had not diagnosed with endometriosis, no additional gynecological patology such as myoma uteri, polype, a history of pelvic inflammatuar disease, a history of cervical or uterine surgery, uterine anomalies	Diagnostic test: Ultrasonography; The identification of optimal ultrasonografic tecniques for determining the location , size and the surgical methods of intestinal endometriotric nodules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometriosis,intestinal	Ultrrasonographic imaging of endometriosis	4 months

Collaborators and Investigators

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): March 8, 2021
• Study Completion (Anticipated): May 8, 2021

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Endometriosis; Diagnostic Imaging
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 2020/147

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No