Bowel Preparation Before 3D Rectal Water Contrast Transvaginal Ultrasonography for Rectosigmoid Endometriosis

Endometriosis, Rectum Clinical Trial

Official title:

Bowel Preparation Before Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography for Diagnosing the Presence and Describing the Characteristics of Rectosigmoid Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04406155
• Other study ID #: BP-3DRWC-TVS-RECTOSIG
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: July 2020
• Source: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Three-dimensional (3D) rendering may be employed during transvaginal rectal water-contrast transvaginal ultrasonography (RWC-TVS) for detecting the presence and describe the characteristics of rectosigmoid endometriosis. This study aims to evaluate the impact of bowel preparation on the diagnostic parameters of 3D-RWC-TVS in women with suspicion of rectosigmoid endometriosis.

Description:

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. In the last years, three-dimensional (3D) rendering has been employed during transvaginal ultrasound for benign gynecological diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2020
• Est. primary completion date: December 1, 2019
• 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

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis, Rectum

Intervention

Procedure:
• 3D-RWC-TVS with bowel preparation
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. Bowel preparation is based on a low-residue diet given in the two days before the examination and a rectal enema administered a few hours before the procedure.
• 3D-RWC-TVS without bowel preparation
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.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Policlinico San Martino	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Ferrero S, Barra F, Stabilini C, Vellone VG, Leone Roberti Maggiore U, Scala C. Does Bowel Preparation Improve the Performance of Rectal Water Contrast Transvaginal Ultrasonography in Diagnosing Rectosigmoid Endometriosis? J Ultrasound Med. 2019 Apr;38(4):1017-1025. doi: 10.1002/jum.14790. Epub 2018 Sep 24. — View Citation

Ferrero S, Scala C, Stabilini C, Vellone VG, Barra F, Leone Roberti Maggiore U. Transvaginal sonography with vs without bowel preparation in diagnosis of rectosigmoid endometriosis: prospective study. Ultrasound Obstet Gynecol. 2019 Mar;53(3):402-409. doi: 10.1002/uog.19194. Epub 2019 Feb 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the accuracy of 3D-RWC-TVS with and without bowel preparation 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 with and without bowel preparation 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 with and without bowel preparation 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