Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in France / NCT06921668
Recruiting Observational

Perioperative Dynamics of Energy Expenditure in Oesophagectomy Patients

NCT06921668 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Rouen
Phase
Observational
Started
2024-09-01
Last updated
2025-04-10

Condition(s) studied

Oesophagectomy

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Determining perioperative dynamics of energy expenditure — Perioperative resting energy expenditure: preoperatively on Day-21/Day-15 or Day-1 of the operation and postoperatively on Day2-Day4 and Day6-Day8
    Describe the perioperative dynamics of energy expenditure in patients undergoing Lewis-Santy carcinological oesophagectomy as a function of surgical technique by indirect calorimetry (assessing resting energy expenditure ).

Trial sites (4)

FacilityCityRegionStatus
Service d'Anesthésie-Réanimation Amiens France Not Yet Recruiting
Department of Anaesthesia and Intensive Care Brest France Not Yet Recruiting
Surgical Intensive Care Department Rouen France Recruiting
Department of Anaesthesia, Intensive Care and Perioperative Medicine Vandœuvre-lès-Nancy France Not Yet Recruiting

More University Hospital, Rouen trials in France

Megarectum in Adults Starting soon
Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot Recruiting
Ticagrelor Hemoadsorption Using Cytosorb® for Reduction of Bleeding During Cardiac Surgery Starting soon
Evaluation of the Influence of Aromatherapy and Music Therapy on Stress During the Management of Cerebral Arteriography Recruiting
Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06921668 on ClinicalTrials.gov ↗ ← All trials in France