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

NCT06776536 | Recruiting

• 1 other identifier: E-96317027-514.10-263823748
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Deeply infiltrating endometriosis; bowel endometriosis; transrectal ultrasound; bowel resection

Outcome Measures

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.

  From enrollment to the 16 months

Secondary Outcomes (1)

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

  From enrollment to 16 months.

Study Arms (1)

Evaluation of Rectal Infiltration Depth and Length in Bowel Infiltrating Endometriosis

EXPERIMENTAL

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

Diagnostic Test: Transrectal ultrasound of the bowel endometriosis during operation

Interventions

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.

Evaluation of Rectal Infiltration Depth and Length in Bowel Infiltrating Endometriosis

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Female with deep endometriosis patients with bowel endometriosis will be enrolled
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

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

Istanbul, 34480, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Hardman D, Bennett R, Mikhail E. Laparoscopic shaving of rectosigmoid deep infiltrating endometriosis under laparoscopic ultrasound guidance. Fertil Steril. 2023 Jul;120(1):206-207. doi: 10.1016/j.fertnstert.2023.04.026. Epub 2023 Apr 26.

  PMID: 37116640 BACKGROUND

• Hudelist G, Ballard K, English J, Wright J, Banerjee S, Mastoroudes H, Thomas A, Singer CF, Keckstein J. Transvaginal sonography vs. clinical examination in the preoperative diagnosis of deep infiltrating endometriosis. Ultrasound Obstet Gynecol. 2011 Apr;37(4):480-7. doi: 10.1002/uog.8935.

  PMID: 21433168 BACKGROUND

• Griffiths A, Koutsouridou R, Vaughan S, Penketh R, Roberts SA, Torkington J. Transrectal ultrasound and the diagnosis of rectovaginal endometriosis: a prospective observational study. Acta Obstet Gynecol Scand. 2008;87(4):445-8. doi: 10.1080/00016340801948318.

  PMID: 18382872 BACKGROUND

• Doniec JM, Kahlke V, Peetz F, Schniewind B, Mundhenke C, Lohnert MS, Kremer B. Rectal endometriosis: high sensitivity and specificity of endorectal ultrasound with an impact for the operative management. Dis Colon Rectum. 2003 Dec;46(12):1667-73. doi: 10.1007/BF02660773.

  PMID: 14668593 BACKGROUND

• Roman H, Kouteich K, Gromez A, Hochain P, Resch B, Marpeau L. Endorectal ultrasound accuracy in the diagnosis of rectal endometriosis infiltration depth. Fertil Steril. 2008 Oct;90(4):1008-13. doi: 10.1016/j.fertnstert.2007.07.1361. Epub 2007 Nov 26.

  PMID: 18023444 BACKGROUND

Related Links

• The European Endometriosis League (EEL) h The aim is to extend public awareness and support scientific research in the field of Endometriosis

Study Officials

• Baris Kaya, Associate Professor,MD

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baris Kaya, Associate Professor

CONTACT

+905323469156; mdbariskaya@gmail.com

Sercan Yuksel, Associate Professor

CONTACT

+905057001666; drsercanyuksel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The radiologist (A) interpreting the preoperative MRI and the radiologist (B) performing the intraoperative TRUS will be different individuals. The radiologist performing the TRUS will be blinded to the patient's clinical information and MRI findings.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professori,MD

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: January 7, 2025
• Primary Completion: April 7, 2026
• Study Completion: April 7, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)