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Perioperative Dynamics of Energy Expenditure in Oesophagectomy Patients

Perioperative Dynamics of Energy Expenditure in Lewis-Santy Oesophagectomy Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06921668
Acronym
OESOCAL
Enrollment
120
Registered
2025-04-10
Start date
2024-09-01
Completion date
2028-01-02
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophagectomy

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.

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.

Interventions

None listed

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Determining perioperative dynamics of energy expenditurePerioperative resting energy expenditure: preoperatively on Day-21/Day-15 or Day-1 of the operation and postoperatively on Day2-Day4 and Day6-Day8Describe 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

MeasureTime frameDescription
Total nutritional intake (vitamin intake)pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4Assessing patients' total nutritional intake in the perioperative period
Total nutritional intake (parenteral/enteral nutrition)pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4Post-operative nutritional support: parenteral/enteral nutrition intake
Total nutritional intake (Trace elements)pre-operatively on Day-21/Day-15 or Day-1 of the operation and post-operatively on Day2-Day4Post-operative nutritional support: trace elements intake
Comparison of calorie targets set with data measured by indirect calorimetryPerioperative resting energy expenditure: preoperatively on Day-21/Day-15 or Day-1 of the operation and postoperatively on Day2-Day4 and Day6-Day8Comparison of calorie targets set by the postoperative artificial nutrition protocol with data measured by indirect calorimetry
Post-operative complicationsat 6 and 12 monthsPostoperative morbidity and mortality, surgical complications evaluation

Countries

France

Contacts

Primary ContactDavid DM MALLET, Director
Secretariat.DRC@chu-rouen.fr2 32 88 82 65
Backup ContactVincent VF FERRANTI, Arc
vincent.ferranti@chu-rouen.fr2 32 88 82 65

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026