NCT06921668 Perioperative Dynamics of Energy Expenditure in Oesophagectomy Patients
| NCT ID | NCT06921668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Rouen |
| Condition | Oesophagectomy |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-09-01 with a primary completion date of 2027-07-01.
⚠ 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
Carcinological oesophageal resection surgery is one of the so-called major digestive surgeries, i.e. involving a high perioperative risk (morbidity and mortality) in patients who are malnourished or at high risk of malnutrition. Nutritional therapy for these patients is an important part of overall perioperative management. Lewis-Santy oesophageal surgery requires a thoracic approach (thoracotomy or thoracoscopy) and an abdominal approach (laparotomy or laparoscopy). Resumption of oral feeding is contraindicated in the immediate postoperative period. The use of a feeding jejunostomy is not systematic. The methods used to manage artificial nutritional support vary between centres, but the foreseeable duration of fasting and/or intake of less than 50% of nutritional requirements is always greater than 5 days. At present, total energy requirements are calculated using formulae that take into account the patient's inflammatory state (stable, unstable or stabilised patient), theoretical ideal weight and previous nutritional status, in order to come as close as possible to actual energy expenditure, and are the subject of perioperative nutrition protocols specific to each centre. Indirect calorimetry makes it possible to reliably measure energy expenditure during the perioperative period. The OESOCAL study continues this line of reasoning. It assumes that energy expenditure may vary according to the surgical approach, and that indirect calorimetry can be used to optimise nutritional support in order to avoid over- or under-nutrition, which may be responsible for an increase in infectious complications.
Eligibility Criteria
Inclusion Criteria: * Any adult patient admitted for scheduled digestive surgery for Lewis Santy oesophagectomy whose care pathway includes a stay in an intensive care unit or continuing care unit. * Member or beneficiary of a social protection scheme * Patient who has read and understood the information letter and does not object to taking part in the study. Exclusion Criteria: * Contraindication to indirect calorimetry (oxygen therapy, etc.) * Refusal to take part in the study * No social security affiliation * Patient is a minor * Patient under legal protection (guardianship) * Pregnant women * Oesophagectomy with cervical approach (3-way oesophagectomy) * Participation in an interventional research protocol likely to have an effect on perioperative nutritional status or surgical technique
Contact & Investigator
Emilie EO OCCHIALI, Doctor
STUDY CHAIR
Surgical Intensive Care Unit, UH of Rouen
Frequently Asked Questions
Who can join the NCT06921668 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oesophagectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06921668 currently recruiting?
Yes, NCT06921668 is actively recruiting participants. Contact the research team at Secretariat.DRC@chu-rouen.fr for enrollment information.
Where is the NCT06921668 trial being conducted?
This trial is being conducted at Amiens, France, Brest, France, Rouen, France, Vandœuvre-lès-Nancy, France.
Who is sponsoring the NCT06921668 clinical trial?
NCT06921668 is sponsored by University Hospital, Rouen. The principal investigator is Emilie EO OCCHIALI, Doctor at Surgical Intensive Care Unit, UH of Rouen. The trial plans to enroll 120 participants.