Gastric Volume and Colorectal Surgery

Postoperative Ileus Clinical Trial

— EVOL  

Official title:

Ultrasonographic Evaluation of the Evolution of the Gastric Volume After Colorectal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04461067
• Other study ID #: 19.12.02.56807
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2020
• Est. completion date: September 2022

Study information

• Verified date: July 2021
• Source: University Hospital, Angers
• Contact: aurélien venara, MD, PhD
• Phone: 0033241353618
• Email: auvenara[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient undergoing colorectal resection whatever the surgical access

Exclusion Criteria:

• contra-indication to ultrasonography performance
• history of gastrectomy

Related Conditions & MeSH terms

• Postoperative Ileus

Intervention

Diagnostic Test:
• ultrasonography
Ultrasonography of the stomach is performed to measure the diameter of the antrum

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diameter of the gastric antrum		immediately before the procedure and each postoperative day up to discharge (mean 7 days)
Secondary	postoperative ileus		in the morning up to 30 postoperative days
Secondary	Postoperative quality of life: GIQLI	GIQLI	before discharge
Secondary	postoperative morbidity	Dindo Clavien Scale (from 1 (minor) to 5 (death))	within 30 postoperative days