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Perioperative Dynamics of Energy Expenditure in Oesophagectomy Patients (OESOCAL)

U

University Hospital, Rouen

Status

Enrolling

Conditions

Oesophagectomy

Study type

Observational

Funder types

Other

Identifiers

NCT06921668
2023/0271/OB
IDRCB : 2023-A02724-41 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

4

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Central trial contact

Vincent VF FERRANTI, Arc; David DM MALLET, Director

Data sourced from clinicaltrials.gov

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