NCT04461067

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 8, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

June 24, 2020

Last Update Submit

July 27, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diameter of the gastric antrum

    immediately before the procedure and each postoperative day up to discharge (mean 7 days)

Secondary Outcomes (3)

  • postoperative ileus

    in the morning up to 30 postoperative days

  • Postoperative quality of life: GIQLI

    before discharge

  • postoperative morbidity

    within 30 postoperative days

Study Arms (1)

Gastric antrum measurement

EXPERIMENTAL
Diagnostic Test: ultrasonography

Interventions

ultrasonographyDIAGNOSTIC_TEST

Ultrasonography of the stomach is performed to measure the diameter of the antrum

Gastric antrum measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient undergoing colorectal resection whatever the surgical access

You may not qualify if:

  • contra-indication to ultrasonography performance
  • history of gastrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, 49933, France

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Aurélien VENARA, MD, PhD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

aurélien venara, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2020

First Posted

July 8, 2020

Study Start

August 8, 2020

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

July 28, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations