Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver SurgerEVOL2NCT07063069
Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting
A study testing Abdominal ultrasound in people with Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver Surger, run by University Hospital, Angers at 1 site in France.
Trial summary
The advent of enhanced rehabilitation after surgery has helped to reduce surgical stress, thereby improving postoperative outcomes by reducing the time it takes for patients to recover their transit and autonomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver Surger
- What is being tested?
- Abdominal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2025to 19 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Major patient
- Indication for major abdominal surgery (submesocolic, parietal, left pancreas or liver)
- Patient affiliated to or benefiting from a social security scheme
- Non-inclusion criteria
- Patient refusal to participate in study
- Need for immediate post-operative ICU stay
Show all 10Show fewer
- Surgery performed as an emergency
- Esophageal, gastric or cephalic pancreatic surgery
- Person deprived of liberty by judicial or administrative decision
- Person under compulsory psychiatric care
Who cannot join
- Discharge with nasogastric tube
- Immediate admission to post-operative intensive care unit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Angers
Angers
Jean-Baptiste Philippe, MD
drci-promotion-interne@chu-angers.fr
About this study
The advent of enhanced rehabilitation after surgery has helped to reduce surgical stress, thereby improving postoperative outcomes by reducing the time it takes for patients to recover their transit and autonomy.
Despite this, some 10-30% of patients undergoing abdominal surgery will experience postoperative ileus or nausea/vomiting. In addition to increasing the length of hospital stay, these complications increase patient discomfort and, above all, the risk of inhalation pneumonitis.
Read more
With the advent of enhanced rehabilitation, patients are receiving less drainage, particularly nasogastric drainage, which is now virtually outlawed in scheduled sub-mesocolic abdominal surgery.
In a recent international multicenter study of patients undergoing colorectal surgery, the authors reported that less than 10% of patients received a nasogastric tube routinely, and that 20% received it for clinical reasons (before or after nausea/vomiting). The authors also reported an overall inhalation pneumonitis rate of 4.2%. The authors concluded from this study that nasogastric tubes should not be inserted routinely, but that delay in nasogastric tube insertion was a risk factor for pneumopathy.
As the onset of postoperative pneumopathy is associated with a risk of mortality, it seems important to predict its risk of onset in order to target patients who could benefit from early nasogastric tube placement.
A recent study carried out in the visceral surgery department of the CHU d'Angers evaluated the evolution of gastric distension. One of the objectives of the ancillary study was to evaluate the interest of the ratio of gastric antrum distension measurement in 2 axes (longitudinal and axial) at D2 postoperative / D preoperative.
As this was an ancillary study of a preliminary study, the number of events was 12, making it impossible to assert with high power that the appearance of nausea/vomiting is linked to the ratio described above. An observational study including more patients is therefore needed to confirm this hypothesis before carrying out a randomized controlled trial.
- Conditions
- Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver Surger
- Being tested
- Abdominal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasoundOther
All patients included will have an abdominal ultrasound scan to mesure anterior/posterior external diameter of gastric antrum upstream of pyloru and external diameter upper/lower of gastric antrum upstream of pylorus
| Study group | Role | What they receive |
|---|---|---|
| Abdominal ultrasound | Experimental | All patients included will have an abdominal ultrasound scan Receives: Other: Abdominal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the sensitivity and specificity of the diagnostic character of the gastric diameter ratio at Day 2 / Day 0
Postoperative ileus is defined according to the Vather et al. criteria.
Measured: Day 2/Day 0 after surgical intervention
Secondary outcomes (2)
assess the sensitivity and specificity of the gastric diameter ratio at D2/D0 in predicting the onset of inhalation pneumonitis
the onset of inhalation pneumonitis, defined as a cough with varying degrees of fever secondary to surgery. Inhalation pneumonitis is clinically suspected and confirmed on imaging with a standard chest X-ray
Measured: Day 2/Day 0 after surgical intervention
code a computer program to automatically measure the diameter of the gastric antrum
Gastric antrum diameter measurements and images
Measured: Day 2/Day 0 after surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start8 Aug 2025
- Primary completion19 Mar 2028 (estimated)
- Study completion19 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver SurgerStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063069
- Sponsor's protocol ID
- 49RC24_0252
- Other IDs
- 2025-A00733-46
- Acronym
- EVOL2
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting
- ClinicalTrials.gov ID
- NCT07063069
- Acronym / sponsor ID
- EVOL2 / 49RC24_0252
- Conditions
- Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver Surger
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 19 Mar 2028 (estimated)
- Study completion
- 19 Mar 2028 (estimated)
- First posted
- 14 Jul 2025 (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.
The advent of enhanced rehabilitation after surgery has helped to reduce surgical stress, thereby improving postoperative outcomes by reducing the time it takes for patients to recover their transit and autonomy.
Despite this, some 10-30% of patients undergoing abdominal surgery will experience postoperative ileus or nausea/vomiting. In addition to increasing the length of hospital stay, these complications increase patient discomfort and, above all, the risk of inhalation pneumonitis.
With the advent of enhanced rehabilitation, patients are receiving less drainage, particularly nasogastric drainage, which is now virtually outlawed in scheduled sub-mesocolic abdominal surgery.
In a recent international multicenter study of patients undergoing colorectal surgery, the authors reported that less than 10% of patients received a nasogastric tube routinely, and that 20% received it for clinical reasons (before or after nausea/vomiting). The authors also reported an overall inhalation pneumonitis rate of 4.2%. The authors concluded from this study that nasogastric tubes should not be inserted routinely, but that delay in nasogastric tube insertion was a risk factor for pneumopathy.
As the onset of postoperative pneumopathy is associated with a risk of mortality, it seems important to predict its risk of onset in order to target patients who could benefit from early nasogastric tube placement.
A recent study carried out in the visceral surgery department of the CHU d'Angers evaluated the evolution of gastric distension. One of the objectives of the ancillary study was to evaluate the interest of the ratio of gastric antrum distension measurement in 2 axes (longitudinal and axial) at D2 postoperative / D preoperative.
As this was an ancillary study of a preliminary study, the number of events was 12, making it impossible to assert with high power that the appearance of nausea/vomiting is linked to the ratio described above. An observational study including more patients is therefore needed to confirm this hypothesis before carrying out a randomized controlled trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal ultrasound | Experimental | Other: Abdominal ultrasoundAll patients included will have an abdominal ultrasound scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Major patient
- Indication for major abdominal surgery (submesocolic, parietal, left pancreas or liver)
- Patient affiliated to or benefiting from a social security scheme
- Non-inclusion criteria
- Patient refusal to participate in study
Key exclusion criteria (2 listed)
- Discharge with nasogastric tube
- Immediate admission to post-operative intensive care unit
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 |
|---|---|---|
| Abdominal ultrasoundAll patients included will have an abdominal ultrasound scan to mesure anterior/posterior external diameter of gastric antrum upstream of pyloru and external diameter upper/lower of gastric antrum upstream of pylorus | Other | Abdominal ultrasound |
Primary outcome
Evaluate the sensitivity and specificity of the diagnostic character of the gastric diameter ratio at Day 2 / Day 0
Time frame: Day 2/Day 0 after surgical intervention
Postoperative ileus is defined according to the Vather et al. criteria.
2 secondary outcomes
assess the sensitivity and specificity of the gastric diameter ratio at D2/D0 in predicting the onset of inhalation pneumonitis
Time frame: Day 2/Day 0 after surgical intervention
code a computer program to automatically measure the diameter of the gastric antrum
Time frame: Day 2/Day 0 after surgical intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal ultrasound in people with Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver Surger, 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 10 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Baptiste Philippe, MD (0241353618 ext. +33, JeanBaptiste.Philippe@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the sensitivity and specificity of the diagnostic character of the gastric diameter ratio at Day 2 / Day 0 (time frame: Day 2/Day 0 after surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.