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

Completed

• Conditions: Endometriosis, Rectum
• Interventions: Procedure: 3D-RWC-TVS with bowel preparation; Procedure: 3D-RWC-TVS without bowel preparation

• Registration Number: NCT04406155
• Lead Sponsor: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

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.

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-01
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with suspicion of rectosigmoid endometriosis	3D-RWC-TVS without bowel preparation	-
Patients with suspicion of rectosigmoid endometriosis	3D-RWC-TVS with bowel preparation	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy