Gastric Volume and Colorectal Surgery | NCT04461067

Studies
Gastric Volume and Colorectal Surgery

NCT04461067

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Jul 28, 2022Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Postoperative Ileus

Interventions

ultrasonography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2020Actual

Primary Completion Date

Aug 2022Estimated

Completion Date

Sep 2022Estimated

First Submitted Date

Jun 24, 2020

First Submission Date that Met QC Criteria

Jul 3, 2020

First Posted Date

Jul 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2022

Last Update Posted Date

Jul 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gastric antrum measurement	Experimental		Diagnostic Test: ultrasonography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasonography	Diagnostic Test	Ultrasonography of the stomach is performed to measure the diameter of the antrum	Gastric antrum measurement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
postoperative ileus		in the morning up to 30 postoperative days
Postoperative quality of life: GIQLI	GIQLI	before discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient undergoing colorectal resection whatever the surgical access

Exclusion Criteria:

contra-indication to ultrasonography performance
history of gastrectomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
aurélien venara, MD, PhD	Contact	0033241353618		auvenara@chu-angers.fr

Overall Officials

Name	Affiliation	Role
Aurélien VENARA, MD, PhD	University Hospital, Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Angers	Recruiting	Angers		49933	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41588201	Derived	Venara A, Paisant A, Gillet J, Morgado L, Rebmann E, Hamel JF. The ultrasonographic measure of postoperative day 2 gastric volume may be a useful tool to improve the management of colorectal surgery patients: results of an ancillary study. Int J Colorectal Dis. 2026 Jan 27;41(1):48. doi: 10.1007/s00384-026-05092-z.

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis