Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting

NCT07063069 | Recruiting

• 2 other identifiers: 49RC24_02522025-A00733-46
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver Surger

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Day 2/Day 0 after surgical intervention

• code a computer program to automatically measure the diameter of the gastric antrum

  Day 2/Day 0 after surgical intervention

Study Arms (1)

Abdominal ultrasound

EXPERIMENTAL

All patients included will have an abdominal ultrasound scan

Other: Abdominal ultrasound

Interventions

Abdominal ultrasound OTHER

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

Abdominal ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major patient
• Indication for major abdominal surgery (submesocolic, parietal, left pancreas or liver)
• Patient affiliated to or benefiting from a social security scheme
• 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

You may not qualify if:

• Discharge with nasogastric tube
• Immediate admission to post-operative intensive care unit

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital of Angers

Angers, France

RECRUITING

Central Study Contacts

Jean-Baptiste Philippe, MD

CONTACT

0241353618; JeanBaptiste.Philippe@chu-angers.fr

Aurelien Venara, MD, PhD

CONTACT

0241353618; auvenara@chu-angers.fr

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 12, 2025
• First Posted: July 14, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): March 19, 2028
• Study Completion (Estimated): March 19, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)