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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
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Female with deep endometriosis patients with bowel endometriosis will be enrolled
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baris Kaya, Associate Professor | Contact | +905323469156 | mdbariskaya@gmail.com | |
| Sercan Yuksel, Associate Professor | Contact | +905057001666 | drsercanyuksel@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Baris Kaya, Associate Professor,MD | Başakşehir Çam & Sakura City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basaksehir Cam ve Sakura City Hospital, Başakşehir Mahallesi G-434 Caddesi No: 2L Başakşehir / İSTANBUL | Recruiting | Istanbul | 34480 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37116640 | Result | 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. | |
| 21433168 | Result | 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. |
| Label | URL |
|---|---|
| The European Endometriosis League (EEL) h The aim is to extend public awareness and support scientific research in the field of Endometriosis | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| institutional review board | View IPD |
"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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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.
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|
| From enrollment to 16 months. |
| 18382872 | Result | 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. |
| 14668593 | Result | 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. |
| 18023444 | Result | 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. |