Gastric Volume and Colorectal Surgery (EVOL)

Ultrasonographic Evaluation of the Evolution of the Gastric Volume After Colorectal

Postoperative ileus (POI) is a serious complication after colorectal surgery. One of its most frequent consequences is the replacement of nasogastric tube because of the vomiting. Vomiting is due to the distension of the stomach and information on the evolution of gastric filling after surgery could help to better understand the physiopathology of POI. It could also give indication to help the physician in the management of POI.

The ultrasonography has been shown to be a reliable technic to assess the gastric emptying.

To date, there is no indication in the literature about the evolution of the gastric filling after colorectal surgery while these information could help to identify patients at risk for POI and to predict the need for POI replacement.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Ileus
• Intervention / Treatment: Diagnostic test: ultrasonography

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • CHU Angers
    • Contact: Aurélien Venara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient undergoing colorectal resection whatever the surgical access

Exclusion Criteria:

• contra-indication to ultrasonography performance
• history of gastrectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastric antrum measurement	Diagnostic test: ultrasonography; Ultrasonography of the stomach is performed to measure the diameter of the antrum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diameter of the gastric antrum	immediately before the procedure and each postoperative day up to discharge (mean 7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative ileus		in the morning up to 30 postoperative days
Postoperative quality of life: GIQLI	GIQLI	before discharge
postoperative morbidity	Dindo Clavien Scale (from 1 (minor) to 5 (death))	within 30 postoperative days

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Aurélien VENARA, MD, PhD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 19.12.02.56807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No