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Kan betere voeding gewichts- en spierverlies bij patiënten die een slokdarmoperatie ondergaan tegengaan?

Can goal directed nutritional support reduce sarcopenia in surgical esophagus patients?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25924
Enrollment
100
Registered
2017-01-11
Start date
2017-02-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Esophageal cancer patients undergoing an esophagectomy

Interventions

Strict nutrtional protocol consisting of: • One dietitian: case manager during all stages of treatment • Use PG-SGA-questionnaire before consult • Weekly registration of nutritional intake • Energ

Sponsors

University Medical Center Groningen Secundary Gelre Hospital Apeldoorn
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patients that undergo a (minimally invasive or hybrid: laparoscopy and thoracotomy or conventional open surgery) esophagectomy for cancer with cervical or intrathoracic anastomosis • Written informed consent • Age > 18 years • Histologically confirmed, previously untreated esophageal cancer • Considered suitable for radical surgery with curative intent. • Squamous cell carcinoma, adenocarcinoma, and undifferentiated carcinoma are included. • Tumor location included the upper, middle, lower thirds of the esophagus and esophagogastric junction tumors, but excluded postcricoid cancers.

Exclusion criteria

Exclusion criteria: • Salvage esophagectomy; after previous histologically confirmed esophageal cancer treated by ‘definitive’ radio- or radiochemotherapy • Inability to provide written consent or inability to fill out questionnaires • Previous or concomitant malignant disease, apart from basal-cell carcinoma • Cervical lymph-node involvement or evidence of metastases. • Karnofsky Performance Status < 80

Design outcomes

Primary

MeasureTime frame
Sarcopenia (muscle loss) measured by psoas muscle index by a CT-scan

Secondary

MeasureTime frame
• Loss of muscle mass, measured by handgrip strength; arm circumference & triceps skinfold thickness; creatinin & urea in 24-hour urine. • Incidence of Clavien Dindo complications • Length of hospital stay and re-admittance rate • Survival • Quality of Life

Contacts

Public ContactMarjo Campmans-Kuijpers

Afdeling Maag, darm- en leverziekten, BB041

M.J.E.Campmans-Kuijpers@UMCG.nl06-55256587

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)