NCT06776536|Recruiting
Evaluation of Rectal Infiltration Depth and Length in Bowel Involvement of Deep Infiltrative Endometriosis (DIE) Using Intraoperative Transrectal Ultrasound (TRUS)
DIE IO TRUS
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DIE IO TRUS
Sponsor study identifier
interventional
15
1 country
1
Study Start
January 7, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 7, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 10, 2025
Actual (reported)January 15, 2025
Actual (reported)April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Demographic informations, patient characteristics, disease related pain scores, surgical informations
From enrollment to 16 months.
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
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.
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Basaksehir Cam ve Sakura City Hospital, Başakşehir Mahallesi G-434 Caddesi No: 2L Başakşehir / İSTANBUL
Istanbul, 34480, Turkey (Türkiye)
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.
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.
Baris Kaya, Associate Professor,MD
Başakşehir Çam & Sakura City Hospital
First Submitted
January 10, 2025
First Posted
January 15, 2025
Study Start
January 7, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
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.
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.
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.
Primary Completion
April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 15, 2025
Record last verified: 2025-01
"IPD will not be shared due to concerns regarding patient confidentiality and privacy, as well as the sensitivity of the data related to rectal endometriosis and intraoperative findings.
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