Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 5:09 AM
Study NCT ID:
NCT07063069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting
Sponsor:
University Hospital, Angers
Organization:
Study Overview
Official Title:
Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVOL2
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-A00733-46 | OTHER | ANSM | View |