Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04339946
Other study ID # 3Dvs2D-RWC-TVS
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date March 1, 2022

Study information

Verified date March 2021
Source Ospedale Policlinico San Martino
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

An accurate diagnosis of the presence, location and extent of the rectosigmoid endometriosis is of paramount importance for the clinicians in order to inform the patients on the potential surgical or medical treatments. It is well established that transvaginal ultrasonography is the first-line investigation in patients with suspicion of deep infiltrating endometriosis. An improvement in the performance of transvaginal ultrasonography in diagnosing rectosigmoid endometriosis may be obtained by using rectal water contrast during transvaginal ultrasonographic scan.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 240
Est. completion date March 1, 2022
Est. primary completion date January 1, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - pain and intestinal symptoms suggestive of rectosigmoid endometriosis Exclusion Criteria: - previous surgical diagnosis of intestinal endometriosis - previous radiological diagnosis of intestinal endometriosis (based on Magnetic Resonance or double-contrast barium enema) - history of colorectal surgery (except appendectomy) - contraindications to bowel preparation or computed colonography (such as non-compliant patients and rectal malformations) - previous bilateral ovariectomy - psychiatric disorders

Study Design


Intervention

Diagnostic Test:
Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS)
Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. Three-dimensional reconstructions convert standard 2D grayscale ultrasound acquisitions into a volumetric dataset.
Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)
Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution.

Locations

Country Name City State
Italy IRCCS Ospedale Policlinico San Martino Genoa

Sponsors (1)

Lead Sponsor Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Morotti M, Ferrero S, Bogliolo S, Venturini PL, Remorgida V, Valenzano Menada M. Transvaginal ultrasonography with water-contrast in the rectum in the diagnosis of bowel endometriosis. Minerva Ginecol. 2010 Jun;62(3):179-85. Review. English, Italian. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the accuracy of 3D-RWC-TVS and 2D-RWC-TVS in the diagnosis of rectosigmoid endometriosis. The results of imaging will be compared with surgical and histological findings. At maximum 6 months before laparoscopic surgical approach
Secondary To compare the precision of 3D-RWC-TVS and 2D-RWC-TVS in estimating the length (mid-sagittal diameter) of the rectosigmoid endometriotic nodules The results of imaging will be compared with surgical and histological findings. At maximum 6 months before laparoscopic surgical approach
Secondary To compare the accuracy of 3D-RWC-TVS and 2D-RWC-TVS in the diagnosis of multifocal rectosigmoid endometriosis. The results of imaging will be compared with surgical and histological findings. At maximum 6 months before laparoscopic surgical approach
Secondary To compare the precision of 3D-RWC-TVS and 2D-RWC-TVS in estimating and the distance between the lower margin of the rectosigmoid endometriotic nodules and the anal verge The results of imaging will be compared with surgical and histological findings. At maximum 6 months before laparoscopic surgical approach
Secondary To compare the precision of 3D-RWC-TVS and 2D-RWC-TVS in estimating rectosigmoid lumen stenosis due to endometriotic nodule The results of imaging will be compared with surgical and histological findings. At maximum 6 months before laparoscopic surgical approach
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Withdrawn NCT03481842 - Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis Phase 1/Phase 2
Recruiting NCT03532074 - Indocyanine Green and Rectosigmoid Endometriosis N/A
Completed NCT03138954 - Endoscopic Rectal UltraSound With Elastosonography and Contrast in Deep Pelvic Endometriosis With Bowel Involvement
Completed NCT04411004 - Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis
Completed NCT04338035 - Fertility in Untreated Rectosigmoid Endometriosis
Active, not recruiting NCT01291576 - Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum N/A
Completed NCT04295343 - Three-dimensional (3D) Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis
Recruiting NCT04398641 - Surgery for Lower Rectum Deep Endometriosis (Segmental/Disc) - Prospective Comparison of Digestive Symptoms and Pain
Completed NCT04406155 - Bowel Preparation Before 3D Rectal Water Contrast Transvaginal Ultrasonography for Rectosigmoid Endometriosis
Completed NCT04296760 - Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis
Recruiting NCT04891003 - The Identification of Optimal Ultrasonografic Tecniques for Determining the Location , Size and the Surgical Methods of Intestinal Endometriotric Nodules
Recruiting NCT05677269 - The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
Active, not recruiting NCT04204707 - Patient Reported Outcomes After Surgery for Rectal Endometriosis
Completed NCT04494568 - Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis N/A
Not yet recruiting NCT04491305 - EHP-5 in Preoperative Assessment in Women With Endometriosis