Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
FEMALE
ID06776536

Evaluation of Rectal Infiltration Depth and Length in Bowel Involvement of Deep Infiltrative Endometriosis Using Intraoperative Transrectal Ultrasound

Led by Başakşehir Çam & Sakura City Hospital · Updated on 2025-01-15

15

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of intraoperative transrectal ultrasound (TRUS) to measure the depth and length of bowel involvement in women with deep infiltrating endometriosis (DIE) who have been diagnosed preoperatively with intestinal endometriosis. The goal is to compare TRUS measurements taken during surgery with preoperative MRI results to assess its effectiveness in this setting. The study focuses on female patients aged 18 to 55 who require bowel resection due to DIE. This is a prospective, single-arm study involving 15 to 40 female participants. Before surgery, patients will undergo pelvic exams, transvaginal ultrasound (TVUS), MRI imaging, and pain assessments using a visual analog scale (VAS). During the bowel resection surgery, TRUS will be performed to measure rectal infiltration depth and length. The TRUS results will then be compared to the MRI findings using statistical methods including sensitivity, specificity, and ROC curve analysis. Participants will be closely monitored from enrollment through 16 months. Evaluations include imaging studies, clinical exams, and pain assessments. The main outcome measure is comparing intraoperative TRUS with preoperative MRI to determine accuracy in assessing rectal involvement. The study is conducted at Istanbul Başakşehir Çam and Sakura City Hospital with teams from gynecology, radiology, and general surgery collaborating.

CONDITIONS

Official Title

Evaluation of Rectal Infiltration Depth and Length in Bowel Involvement of Deep Infiltrative Endometriosis (DIE) Using Intraoperative Transrectal Ultrasound (TRUS)

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 55
  • Diagnosed with bowel involvement due to deep infiltrative endometriosis
  • Requires bowel resection surgery
  • Minimum of 15 participants included
Not Eligible

You will not qualify if you...

  • Patients with bowel endometriosis not requiring bowel resection
  • Patients with other bowel diseases such as rectal tumors, Crohn's disease, or ulcerative colitis

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Trial Site Locations

Total: 1 location

1

Basaksehir Cam ve Sakura City Hospital, Başakşehir Mahallesi G-434 Caddesi No: 2L Başakşehir / İSTANBUL

Istanbul, Turkey (Türkiye), 34480

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Research Team

B

Baris Kaya, Associate Professor

S

Sercan Yuksel, Associate Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Transrectal ultrasound and the diagnosis of rectovaginal endometriosis: a prospective observational study.

Anthony Griffiths, Roxani Koutsouridou, Sue Vaughan...

https://pubmed.ncbi.nlm.nih.gov/18382872

Rectal endometriosis: high sensitivity and specificity of endorectal ultrasound with an impact for the operative management.

J Marek Doniec, Volker Kahlke, Frederik Peetz...

https://pubmed.ncbi.nlm.nih.gov/14668593