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Hoe is de opname van voeding bij mensen die een HIPEC ondergaan?


- candidate number26470
- NTR NumberNTR6327
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jan-2017
- Secondary IDsNL57812.042.16  SMal-Hipec 201600362
- Public TitleHoe is de opname van voeding bij mensen die een HIPEC ondergaan?
- Scientific TitlePredictive factors for sarcopenia and malabsorption in high risk surgical oncological patients after cytoreductive surgery and HIPEC procedure
- ACRONYMSMal-HIPEC
- hypothesisPossible predictive factors for sarcopenia (primary outcome) could be: 1. The length and part of the resected small intestine, 2. Adjuvant (and type of) chemotherapy postoperatively, 3. Complications (like sepsis), 4. Nutritional intake (Energy and protein), 5. Preoperative muscle loss (sarcopenia), 6. Movement.
Possible predictive factors for malabsorption (secondary outcome) could be 1. The length and part of the resected small intestine 2. Adjuvant (and type of) chemotherapy postoperatively 3. Small intestinal bacterial overgrowth, especially when the ileocecal valve dysfunctions
- Healt Condition(s) or Problem(s) studiedHIPEC
- Inclusion criteria Patients that undergo CRS and HIPEC procedure at the University Medical Center Groningen (UMCG)
Written informed consent
Age > 18 years
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
Not fit for surgery
Inability to provide written consent or inability to fill out questionnaires
Karnofsky Performance Status < 80
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2017
- planned closingdate1-okt-2020
- Target number of participants70
- InterventionsNone, this is an explorative observational trial
- Primary outcomeSarcopenia defined as the degenerative loss of skeletal muscle mass that can be quantified by the CT measurement of the psoas muscle surface, normalized for patient height [cm2 m−2].
- Secondary outcome Malabsorption
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
- TimepointsSarcopenia will be measured before surgery and 12 months after surgery.
The other endpoints will be registered at 3 and 6 months after surgery as well
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Marjo Campmans-Kuijpers
- CONTACT for SCIENTIFIC QUERIESDr. Marjo Campmans-Kuijpers
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryIn this explorative observational study we will study the predictive factors for sarcopenia and malabsorption in patients with abdominal cancer undergoing cytoreductive surgery (CRS) combined with hyperthermal intraperitoneal chemotherapy
- Main changes (audit trail)
- RECORD11-jan-2017 - 12-okt-2017


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