Perioperative Dynamics of Energy Expenditure in Oesophagectomy Patients

NCT ID: NCT06921668

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2028-01-02

Brief Summary

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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

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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.

Conditions

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Oesophagectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilie EO OCCHIALI, Doctor

Role: STUDY_CHAIR

Surgical Intensive Care Unit, UH of Rouen

Locations

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Service d'Anesthésie-Réanimation

Amiens, , France

Site Status NOT_YET_RECRUITING

Department of Anaesthesia and Intensive Care

Brest, , France

Site Status NOT_YET_RECRUITING

Surgical Intensive Care Department

Rouen, , France

Site Status RECRUITING

Department of Anaesthesia, Intensive Care and Perioperative Medicine

Vandœuvre-lès-Nancy, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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David DM MALLET, Director

Role: CONTACT

2 32 88 82 65 ext. +33

Vincent VF FERRANTI, Arc

Role: CONTACT

2 32 88 82 65 ext. +33

Facility Contacts

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Léonie LV VILLERET, Doctor

Role: primary

3 22 08 78 78 ext. +33

Thomas TG GARGADENNEC, Doctor

Role: primary

2 30 33 78 94 ext. +33

Emilie EO OCCHIALI, Doctor

Role: primary

2 32 88 17 29 ext. +33

Anaïs AC CREY, Doctor

Role: backup

2 32 88 17 29 ext. +33

Julien JB BIRCKENER, Doctor

Role: primary

3 83 15 52 39 ext. +33

Other Identifiers

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IDRCB : 2023-A02724-41

Identifier Type: OTHER

Identifier Source: secondary_id

2023/0271/OB

Identifier Type: -

Identifier Source: org_study_id

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