NCT07063069 Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting
| NCT ID | NCT07063069 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver Surger |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2028-03-19 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-08-08 with a primary completion date of 2028-03-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * Discharge with nasogastric tube * Immediate admission to post-operative intensive care unit
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07063069 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver Surger. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07063069 currently recruiting?
Yes, NCT07063069 is actively recruiting participants. Contact the research team at JeanBaptiste.Philippe@chu-angers.fr for enrollment information.
Where is the NCT07063069 trial being conducted?
This trial is being conducted at Angers, France.
Who is sponsoring the NCT07063069 clinical trial?
NCT07063069 is sponsored by University Hospital, Angers. The trial plans to enroll 150 participants.