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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorBaşakşehir Çam & Sakura City Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Transrectal ultrasound of the bowel endometriosis during operation

    Diagnostic test

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Evaluation of Rectal Infiltration Depth and Length in Bowel Infiltrating EndometriosisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative transrectal ultrasound of the rectal involvement of the deep infiltrating endometriosis will be compared with preoperative MRI

Patients diagnosed with rectal endometriosis and planned for bowel resection will undergo intraoperative transrectal ultrasound during laparoscopy. The transrectal ultrasound will be performed by a blinded radiologist, and the location, depth, and length of rectal involvement in DIE will be measured in millimeters using TRUS. These findings will be recorded. The results will be compared with preoperative MRI results which was performed by another radiologist for this study.

Time frame
From enrollment to the 16 months

Secondary outcomes

1

Demographic informations, patient characteristics, disease related pain scores, surgical informations

Patient demographic information, including age, BMI, known comorbidities, mode and number of deliveries, previous surgeries, and preoperative medical treatments, will be collected. Pain characteristics and visual analog score (VAS) scores for dysmenorrhea, dyspareunia, dysuria, dyschezia, and chronic pelvic pain will be retrieved from the hospital records or patient files. Surgical parameters, such as the type and duration of surgery will be recorded. Early postoperative complications will be recorded.

Time frame
From enrollment to 16 months.

Other outcomes

Sponsors and contacts

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