Postoperative IleusEVOLNCT04461067
Gastric Volume and Colorectal Surgery
A study testing ultrasonography in people with Postoperative Ileus, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2020to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient undergoing colorectal resection whatever the surgical access
Who cannot join
- contra-indication to ultrasonography performance
- history of gastrectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Postoperative Ileus
- Being tested
- ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDiagnostic test
Ultrasonography of the stomach is performed to measure the diameter of the antrum
| Study group | Role | What they receive |
|---|---|---|
| Gastric antrum measurement | Experimental | Not described Receives: Diagnostic Test: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of the gastric antrum
Measured: immediately before the procedure and each postoperative day up to discharge (mean 7 days)
Secondary outcomes (3)
postoperative ileus
Measured: in the morning up to 30 postoperative days
Postoperative quality of life: GIQLI
GIQLI
Measured: before discharge
postoperative morbidity
Dindo Clavien Scale (from 1 (minor) to 5 (death))
Measured: within 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start8 Aug 2020
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aurélien VENARA, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461067
- Sponsor's protocol ID
- 19.12.02.56807
- Acronym
- EVOL
- Status last verified
- Jul 2021
- First submitted
- 24 Jun 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41588201
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of the Evolution of the Gastric Volume After Colorectal
- ClinicalTrials.gov ID
- NCT04461067
- Acronym / sponsor ID
- EVOL / 19.12.02.56807
- Conditions
- Postoperative Ileus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric antrum measurement | Experimental | Diagnostic Test: ultrasonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient undergoing colorectal resection whatever the surgical access
Key exclusion criteria (2 listed)
- contra-indication to ultrasonography performance
- history of gastrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonographyUltrasonography of the stomach is performed to measure the diameter of the antrum | Diagnostic test | Gastric antrum measurement |
Primary outcome
Diameter of the gastric antrum
Time frame: immediately before the procedure and each postoperative day up to discharge (mean 7 days)
3 secondary outcomes
postoperative ileus
Time frame: in the morning up to 30 postoperative days
Postoperative quality of life: GIQLI
Time frame: before discharge
postoperative morbidity
Time frame: within 30 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Derived from this study: PubMed 41588201Venara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélien VENARA, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonography in people with Postoperative Ileus, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact aurélien venara, MD, PhD (0033241353618, auvenara@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diameter of the gastric antrum (time frame: immediately before the procedure and each postoperative day up to discharge (mean 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04461067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.