Clinical trial NCT04296760: Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis
Official title: Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis, Rectum
Endometriosis of Vagina
Endometriosis Rectovaginal Septum
Endometriosis Pelvic
Endometriosis of Colon
Endometriosis
Keywords: rectosigmoid endometriosis; posterior pelvic deep endometriosis; vaginal endometriosis; rectovaginal endometriosis
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspicion of posterior deep infiltrating endometriosis, referring to our academic department for diagnostic purposes

Brief summary: As the surgical treatment of posterior deep endometriosis may be challenging for surgeons and carry significant risks for patients, preoperative assessment of the location, characteristics and presence of nodules of posterior deep endometriosis is important in order to inform the patient about the various treatment possibilities and to allow adequate counseling regarding treatment strategy. The aim of this study is to investigate the accuracy of rectal water-contrast transvaginal ultrasonography (RWC-TVS), and sonovaginography (SVG) in patients with clinical suspicion of posterior deep endometriosis (DIE).


Eligibility criteria: Inclusion Criteria:

* clinical presentation suggestive of the presence of posterior deep infiltrating endometriosis

Exclusion Criteria:

* previous diagnosis of posterior deep infiltrating endometriosis by radiologic imaging (i.e. magnetic resonance, computed tomography)
* previous surgical diagnosis of posterior deep infiltrating endometriosis

Primary outcomes:
measure: Accuracy in diagnosing the presence of the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina
timeFrame: At maximum 6 months before undergoing laparoscopic surgical approach
Secondary outcomes:
measure: Accuracy in estimating the deep of infiltration in the intestinal muscolari propria of nodules of rectosigmoid endometriosis
timeFrame: At maximum 6 months before undergoing laparoscopic surgical approach
measure: Accuracy in estimating the distance between rectosigmoid endometriosis nodules and the anal verge
timeFrame: At maximum 6 months before undergoing laparoscopic surgical approach
measure: Accuracy in diagnosing the presence of multifocal rectosigmoid endometriosis
timeFrame: At maximum 6 months before undergoing laparoscopic surgical approach
measure: Accuracy in estimating the largest diameter of endometriosis nodules in the following sites of posterior deep endometriosis: rectovaginal septum, rectosigmoid, uterosacral ligaments, and vagina
timeFrame: At maximum 6 months before undergoing laparoscopic surgical approach
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: Ospedale Policlinico San Martino
Study officials:
affiliation: Ospedale Policlinico San Martino
name: Fabio Barra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leone Roberti Maggiore U, Biscaldi E, Vellone VG, Venturini PL, Ferrero S. Magnetic resonance enema vs rectal water-contrast transvaginal sonography in diagnosis of rectosigmoid endometriosis. Ultrasound Obstet Gynecol. 2017 Apr;49(4):524-532. doi: 10.1002/uog.15934.
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.