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NCT Number: NCT06921668

Perioperative Dynamics of Energy Expenditure in 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Anesthésie-Réanimation, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Determining perioperative dynamics of energy expenditure

    Time frame: 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 ).

Secondary outcomes

  1. Total nutritional intake (vitamin intake)

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

    Assessing patients' total nutritional intake in the perioperative period

  2. Total nutritional intake (parenteral/enteral nutrition)

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

    Post-operative nutritional support: parenteral/enteral nutrition intake

  3. Total nutritional intake (Trace elements)

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

    Post-operative nutritional support: trace elements intake

  4. Comparison of calorie targets set with data measured by indirect calorimetry

    Time frame: Perioperative resting energy expenditure: preoperatively on Day-21/Day-15 or Day-1 of the operation and postoperatively on Day2-Day4 and Day6-Day8

    Comparison of calorie targets set by the postoperative artificial nutrition protocol with data measured by indirect calorimetry

  5. Post-operative complications

    Time frame: at 6 and 12 months

    Postoperative morbidity and mortality, surgical complications evaluation

Study contacts

Contact information is provided by the study sponsor or research team.

David DM MALLET, Director

CONTACT

[email protected]

2 32 88 82 65 ext. +33

Vincent VF FERRANTI, Arc

CONTACT

[email protected]

2 32 88 82 65 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Perioperative Dynamics of Energy Expenditure in Lewis-Santy Oesophagectomy Patients

Acronym: OESOCAL

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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