Evaluation of Rectal Infiltration Depth and Length in Bowel Involvement of Deep Infiltrative Endometriosis (DIE) Using Intraoperative Transrectal Ultrasound (TRUS)
NCT ID: NCT06776536
Last Updated: 2025-01-15
Study Results
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Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2025-01-07
2026-04-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Evaluation of Rectal Infiltration Depth and Length in Bowel Infiltrating Endometriosis
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
Transrectal ultrasound of the bowel endometriosis during operation
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.
Interventions
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Transrectal ultrasound of the bowel endometriosis during operation
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
\-
18 Years
55 Years
FEMALE
No
Sponsors
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Başakşehir Çam & Sakura City Hospital
OTHER_GOV
Responsible Party
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Baris KAYA
Associate Professori,MD
Principal Investigators
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Baris Kaya, Associate Professor,MD
Role: PRINCIPAL_INVESTIGATOR
Başakşehir Çam & Sakura City Hospital
Locations
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Basaksehir Cam ve Sakura City Hospital, Başakşehir Mahallesi G-434 Caddesi No: 2L Başakşehir / İSTANBUL
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Baris Kaya, Associate Professor
Role: backup
References
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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.
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.
Study Documents
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Document Type: institutional review board
View DocumentRelated Links
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The European Endometriosis League (EEL) h The aim is to extend public awareness and support scientific research in the field of Endometriosis
Other Identifiers
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E-96317027-514.10-263823748
Identifier Type: -
Identifier Source: org_study_id
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