Clinical trial NCT04295343: Three-dimensional (3D) Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis
Official title: Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis, Sigmoid
Endometriosis, Rectum
Keywords: Rectosigmoid endometriosis
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical presentation suspected for rectosigmoid endometriosis

Brief summary: Rectosigmoid involvement by endometriosis causes intestinal symptoms such as constipation, diarrhea, and dyschezia. A non-invasive diagnosis of bowel endometriosis is relevant to provide the patients information on the potential hormonal or surgical treatments. The objective of the current study was to compare the performance of three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS) and computed colonography (CTC) in predicting the presence and characteristics of rectosigmoid endometriosis.


Eligibility criteria: 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

Primary outcomes:
measure: To compare the accuracy of 3D-RWC-TVS and CTC in the diagnosis of rectosigmoid endometriosis.
timeFrame: At maximum 6 months before laparoscopic surgical approach
Secondary outcomes:
measure: To compare the precision of 3D-RWC-TVS and CTC in estimating the length (mid-sagittal diameter) of the rectosigmoid endometriotic nodules
timeFrame: At maximum 6 months before laparoscopic surgical approach
measure: To compare the accuracy of 3D-RWC-TVS and CTC in the diagnosis of multifocal rectosigmoid endometriosis.
timeFrame: At maximum 6 months before laparoscopic surgical approach
measure: To compare the precision of 3D-RWC-TVS and CTC in estimating and the distance between the lower margin of the rectosigmoid endometriotic nodules and the anal verge
timeFrame: At maximum 6 months before laparoscopic surgical approach
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
Study officials:
affiliation: IRCCS Ospedale Policlinico San Martino
name: Simone Ferrero, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Ferrero S, Biscaldi E, Vellone VG, Venturini PL, Leone Roberti Maggiore U. Computed tomographic colonography vs rectal water- contrast transvaginal sonography in diagnosis of rectosigmoid endometriosis: a pilot study. Ultrasound Obstet Gynecol. 2017 Apr;49(4):515-523. doi: 10.1002/uog.15905.
citation: 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. English, Italian.
citation: Barra F, Biscaldi E, Scala C, Lagana AS, Vellone VG, Stabilini C, Ghezzi F, Ferrero S. A Prospective Study Comparing Three-Dimensional Rectal Water Contrast Transvaginal Ultrasonography and Computed Tomographic Colonography in the Diagnosis of Rectosigmoid Endometriosis. Diagnostics (Basel). 2020 Apr 24;10(4):252. doi: 10.3390/diagnostics10040252.