To investigate the predictive factors for sarcopenia in high risk surgical oncological patients undergoing a CRS + HIPEC procedure. The secondary goal is to investigate the predictive factors for malabsorption and the incidence of anastomic leakage…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Electrolyte and fluid balance conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sarcopenia (Muscle loss), measured by the psoas muscle density is the primary
outcome
Secondary outcome
Malabsorption, measured by the fecal energy by bomb calorimetry [kcal/d] is the
secondary outcome.
Other endpoints are anastomic leakage, pneumonia, infection, length of hospital
stay, readmission rate, and one-year survival.
Background summary
Cytoreductive surgery (CRS) in combination with hyperthermic intraperitoneal
chemotherapy (HIPEC) provides a promising therapeutic strategy for patients
with gastrointestinal cancer. Sarcopenia and malabsorption are common in
patients after CRS + HIPEC surgery and are associated with an increase on
postoperative complications. therefore, this study aims to investigate the
predictive factors for sarcopenia and malabsorption in high risk surgical
oncological patients undergoing a CRS + HIPEC procedure
Study objective
To investigate the predictive factors for sarcopenia in high risk surgical
oncological patients undergoing a CRS + HIPEC procedure. The secondary goal is
to investigate the predictive factors for malabsorption and the incidence of
anastomic leakage, pneumonia, infection and length of hospital stay,
readmission rate and survival in these patients, one year after surgery.
Study design
A one-year observational study
Study burden and risks
5x measuring upper arm and handgrip strength
5x physical examination and questions about nutrition (PG_SGA) (5 minutes)
3 x questionnaire quality of life (5 minutes)
3x collection 24-hour urine
2x keep their dieet steady and notate their food intake during 4 consecutive
days and collection of feces on 2nd, 3rd and 4th day (bomb calorimetry)
2x analysis of oxygen and cardioxide while lying on a bed (15 minutes)
(indirect calorimetry)
3x 2 extra tubes of blood
Wear a pedometer for 2 days prior to visiting the surgeon
All these test together will take about 3 hours to complete. The blood donation
can cause pain and bruising. Their is no extra punction needed for this
donation. Keeping the diet steady for 4 consecutive days and collect the stool
can be burdensome for the patient.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Patients > 18 years that undergo CRS and HIPEC procedure at the University Medical Center Groningen (UMCG)
Exclusion criteria
All patients not eligible for CRS and HIPEC procedure
not fit for surgery or
unable to provide written consent or inability to fill out questionnaires
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL57812.042.16 |
| OMON | NL-OMON28190 |