Perioperative Dynamics of Energy Expenditure in Oesophagectomy Patients (OESOCAL)

Perioperative Dynamics of Energy Expenditure in Lewis-Santy Oesophagectomy Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Oesophagectomy

Detailed Description

The results of this study should enable current nutrition protocols to evolve and nutritional support to be incorporated into a more global project of individualised perioperative medicine.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: David DM MALLET, Director; Phone Number: +33 2 32 88 82 65; Email: Secretariat.DRC@chu-rouen.fr
• Study Contact Backup: Name: Vincent VF FERRANTI, Arc; Phone Number: +33 2 32 88 82 65; Email: vincent.ferranti@chu-rouen.fr

Study Locations

• France
  • Amiens, France, 80054
    • Not yet recruiting
    • Service d'Anesthésie-Réanimation
    • Contact: Léonie LV VILLERET, Doctor; Phone Number: +33 3 22 08 78 78; Email: villeret.leonie@chu-amiens.fr
  • Brest, France, 29200
    • Not yet recruiting
    • Department of Anaesthesia and Intensive Care
    • Contact: Thomas TG GARGADENNEC, Doctor; Phone Number: +33 2 30 33 78 94; Email: thomas.gargadennec@chu-brest.fr
  • Rouen, France, 76031
    • Recruiting
    • Surgical Intensive Care Department
    • Contact: Emilie EO OCCHIALI, Doctor; Phone Number: +33 2 32 88 17 29; Email: emilie.occhiali@chu-rouen.fr
    • Contact: Anaïs AC CREY, Doctor; Phone Number: +33 2 32 88 17 29; Email: anais.crey@chu-rouen.fr
  • Vandoeuvre-les-Nancy, France, 54511
    • Not yet recruiting
    • Department of Anaesthesia, Intensive Care and Perioperative Medicine
    • Contact: Julien JB BIRCKENER, Doctor; Phone Number: +33 3 83 15 52 39; Email: j.birckener@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Consecutive adult patient admitted for digestive surgery for Lewis Santy oesophagectomy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining perioperative dynamics of energy expenditure	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 ).	Perioperative resting energy expenditure: preoperatively on Day-21/Day-15 or Day-1 of the operation and postoperatively on Day2-Day4 and Day6-Day8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total nutritional intake (vitamin intake)	Assessing patients' total nutritional intake in the perioperative period	pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4
Total nutritional intake (parenteral/enteral nutrition)	Post-operative nutritional support: parenteral/enteral nutrition intake	pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4
Total nutritional intake (Trace elements)	Post-operative nutritional support: trace elements intake	pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4
Comparison of calorie targets set with data measured by indirect calorimetry	Comparison of calorie targets set by the postoperative artificial nutrition protocol with data measured by indirect calorimetry	Perioperative resting energy expenditure: preoperatively on Day-21/Day-15 or Day-1 of the operation and postoperatively on Day2-Day4 and Day6-Day8
Post-operative complications	Postoperative morbidity and mortality, surgical complications evaluation	at 6 and 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Study Chair: Emilie EO OCCHIALI, Doctor, Surgical Intensive Care Unit, UH of Rouen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 2, 2028

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023/0271/OB; IDRCB : 2023-A02724-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data provided will be the property of the sponsor and will be used solely for its own research activities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No