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

Başakşehir Çam & Sakura City Hospital

Status: Enrolling

Conditions: Bowel Endometriosis; Deep Infiltrating Endometriosis (DIE); Bowel Resection; Transrectal Ultrasound

Treatments: Diagnostic Test: Transrectal ultrasound of the bowel endometriosis during operation

Study type: Interventional

Funder types: Other

Identifiers

NCT06776536

E-96317027-514.10-263823748

Details and patient eligibility

About

we aim to evaluate the success of intraoperative transrectal ultrasound in measuring the depth and extent of bowel involvement in patients preoperatively diagnosed with intestinal endometriosis using transvaginal ultrasound and MRI, and who are planned for bowel resection

Full description

This is a prospective, single-arm study aimed at evaluating the efficacy of intraoperative transrectal ultrasound (TRUS) in assessing rectal infiltration depth and length in patients with bowel involvement due to deep infiltrative endometriosis (DIE). The study will include 15-40 female patients aged 18-55, diagnosed with intestinal endometriosis preoperatively using transvaginal ultrasound and MRI, and scheduled for bowel resection.

Preoperative evaluations will include pelvic examination, imaging (TVUS and MRI), and pain assessment using a visual analog scale (VAS). During surgery, TRUS will be used to measure the depth and length of rectal involvement, and findings will be compared with preoperative MRI results. Data will be analyzed using statistical methods, including sensitivity, specificity, and ROC curve analysis, to determine the diagnostic performance of TRUS.

The study will be conducted at Istanbul Başakşehir Çam and Sakura City Hospital, with multidisciplinary contributions from gynecology, radiology, and general surgery teams.

Enrollment: 15 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The study will include a minimum of 15 female patients aged 18-55 with bowel involvement due to deep infiltrative endometriosis, requiring bowel resection.

Exclusion criteria

Patients with bowel endometriosis who does not require bowel resection, patients who have other bowel diseases, such as rectal tumors, Crohn's disease, or ulcerative colitis, will be excluded.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Evaluation of Rectal Infiltration Depth and Length in Bowel Infiltrating Endometriosis

Experimental group

Description:

This study aims to investigate the feasibility of measuring the depth and extent of bowel involvement using intraoperative transrectal ultrasound in patients undergoing surgery for intestinal endometriosis

Treatment:

Diagnostic Test: Transrectal ultrasound of the bowel endometriosis during operation