Three-dimensional (3D) Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis

Completed

• Conditions: Endometriosis, Sigmoid; Endometriosis, Rectum
• Interventions: Diagnostic Test: Three-dimensional (3D) rectal water contrast transvaginal ultrasonography; Diagnostic Test: Computed colonography

• Registration Number: NCT04295343
• Lead Sponsor: Ospedale Policlinico San Martino

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2019-09-01
• Study Completion: 2020-02-01
• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-04
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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 suspicious of rectosigmoid endometriosis	Computed colonography	-
Patients with suspicious of rectosigmoid endometriosis	Three-dimensional (3D) rectal water contrast transvaginal ultrasonography	-

Primary Outcome Measures

Name	Time	Method
To compare the accuracy of 3D-RWC-TVS and CTC 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 accuracy of 3D-RWC-TVS and CTC 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.
To compare the precision of 3D-RWC-TVS and CTC 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 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	At maximum 6 months before laparoscopic surgical approach	The results of imaging will be compared with surgical and histological findings.

Trial Locations

Locations (1)

Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy