Perioperative Dynamics of Energy Expenditure in Oesophagectomy Patients

NCT06921668 | Recruiting

• 2 other identifiers: 2023/0271/OBIDRCB : 2023-A02724-41
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 4

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.

Conditions

Oesophagectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total nutritional intake (vitamin intake)

  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)

  pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4

• Total nutritional intake (Trace elements)

  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

  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

  at 6 and 12 months

Eligibility Criteria

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

Study Population

Consecutive adult patient admitted for digestive surgery for Lewis Santy oesophagectomy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (4)

Service d'Anesthésie-Réanimation

Amiens, 80054, France

NOT YET RECRUITING

Department of Anaesthesia and Intensive Care

Brest, 29200, France

NOT YET RECRUITING

Surgical Intensive Care Department

Rouen, 76031, France

RECRUITING

Department of Anaesthesia, Intensive Care and Perioperative Medicine

Vandœuvre-lès-Nancy, 54511, France

NOT YET RECRUITING

Study Officials

• Emilie EO OCCHIALI, Doctor

  Surgical Intensive Care Unit, UH of Rouen

  STUDY CHAIR

Central Study Contacts

David DM MALLET, Director

CONTACT

2 32 88 82 65; Secretariat.DRC@chu-rouen.fr

Vincent VF FERRANTI, Arc

CONTACT

2 32 88 82 65; vincent.ferranti@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 10, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 2, 2028
• Last Updated: April 10, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)