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

Sponsor
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia (Other)
Overall Status
Completed
CT.gov ID
NCT04406155
Collaborator
(none)
60
1
24
2.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 3D-RWC-TVS with bowel preparation
  • Procedure: 3D-RWC-TVS without bowel preparation

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Bowel Preparation Before Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography for Diagnosing the Presence and Describing the Characteristics of Rectosigmoid Endometriosis
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Patients with suspicion of rectosigmoid endometriosis

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.

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.

Outcome Measures

Primary Outcome Measures

  1. To compare the accuracy of 3D-RWC-TVS with and without bowel preparation in the diagnosis of rectosigmoid endometriosis. [At maximum 6 months before laparoscopic surgical approach]

    The results of imaging will be compared with surgical and histological findings.

Secondary Outcome Measures

  1. 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 [At maximum 6 months before laparoscopic surgical approach]

    The results of imaging will be compared with surgical and histological findings.

  2. To compare the accuracy of 3D-RWC-TVS with and without bowel preparation in the diagnosis of multifocal rectosigmoid endometriosis. [At maximum 6 months before laparoscopic surgical approach]

    The results of imaging will be compared with surgical and histological findings.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Ospedale Policlinico San Martino Genova Italy

Sponsors and Collaborators

  • Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Investigators

  • Study Director: Simone Ferrero, MD, PhD, IRRCS Ospedale Policlinico San Martino

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Simone Ferrero, Principal Investigator, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
ClinicalTrials.gov Identifier:
NCT04406155
Other Study ID Numbers:
  • BP-3DRWC-TVS-RECTOSIG
First Posted:
May 28, 2020
Last Update Posted:
Jul 27, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Simone Ferrero, Principal Investigator, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2020